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Cognitive Behaviour Therapy

ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/sbeh20

Tailored internet-based cognitive behavioral


therapy for individuals with chronic pain and
comorbid psychological distress: a randomized
controlled trial

Nils Gasslander, Gerhard Andersson, Frida Boström, Lisa Brandelius, Lotta


Pelling, Lovisa Hamrin, Torsten Gordh & Monica Buhrman

To cite this article: Nils Gasslander, Gerhard Andersson, Frida Boström, Lisa Brandelius,
Lotta Pelling, Lovisa Hamrin, Torsten Gordh & Monica Buhrman (2022) Tailored internet-
based cognitive behavioral therapy for individuals with chronic pain and comorbid psychological
distress: a randomized controlled trial, Cognitive Behaviour Therapy, 51:5, 408-434, DOI:
10.1080/16506073.2022.2065528

To link to this article: https://doi.org/10.1080/16506073.2022.2065528

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COGNITIVE BEHAVIOUR THERAPY
2022, VOL. 51, NO. 5, 408–434
https://doi.org/10.1080/16506073.2022.2065528

Tailored internet-based cognitive behavioral therapy for


individuals with chronic pain and comorbid psychological
distress: a randomized controlled trial
Nils Gasslander a, Gerhard Andersson b,c, Frida Boström a, Lisa Brandelius a,
Lotta Pelling a, Lovisa Hamrin a, Torsten Gordh d and Monica Buhrman a
a
Department of Psychology, Uppsala University, Uppsala, Sweden; bDepartment of Behavioural Sciences and
Learning; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden;
c
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; dDepartment of Surgical
Sciences, Pain Research, Uppsala University, Uppsala, Sweden

ABSTRACT ARTICLE HISTORY


Comorbid psychological problems are commonly related to chronic Received 3 June 2021
pain but addressing heterogeneous comorbidities in traditional Accepted 8 April 2022
settings is often difficult. Delivering individually tailored treatment KEYWORDS
using the internet could be a viable alternative. The present study Internet; cognitive behavior
investigates whether a guided, individually tailored and internet- therapy; chronic pain;
delivered cognitive behavioral therapy (ICBT) could improve mood depression; disability
and reduce disability in individuals suffering from chronic pain and
comorbid psychological distress.
Participants were recruited from a pain clinic and randomized to
either ICBT or waiting list. The participants (n = 187) individually
tailored treatments included 6–13 modules targeting different
types of psychological distress. Modules were designed to be com­
pleted weekly, and feedback was provided by clinicians.
Participants completed an average of 5.1 (49.7%) modules, with
22.9% completing all assigned modules. Intention-to-treat analyses
showed significantly larger improvements in depression, disability,
pain acceptance, catastrophizing, and quality of life in the ICBT-
group compared to the control group. Between-group effect sizes
were very small or small at post for the primary outcomes depres­
sion (d = 0.18) and pain interference (d = 0.22). Other effect sizes
ranged from very small to small, with the largest effect being
improvements in pain acceptance (d = 0.3). All significant changes
were stable at 12-month follow up.

Introduction
Comorbid psychological problems are commonly related to chronic pain, with depressed
mood and increased anxiety being more common than in the general population.
Consequently, comorbid psychiatric disorders are also more common (Demyttenaere
et al., 2007; Velly & Mohit, 2018). This is unsurprising since pain in itself is an inherently

CONTACT Nils Gasslander nils.gasslander@psyk.uu.se Department of Psychology, Uppsala University, Uppsala,


Sweden
This article has been corrected with minor changes. These changes do not impact the academic content of the article.
Supplemental data for this article can be accessed online at https://doi.org/10.1080/16506073.2022.2065528
© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License
(http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any med­
ium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
COGNITIVE BEHAVIOUR THERAPY 409

negative experience that limits functioning, and lowers overall activity levels.
Additionally, chronic pain can lead to psychosocial issues and many patients report
problems with communication, relationships, finances and stress (Westman, 2010).
Besides constituting an added burden to the patient, the relationship between pain and
psychological distress seem to be reciprocal, with psychological issues influencing how
pain affects daily functioning, and it has been observed that emotional distress can
contribute to, or even maintain, the pain condition (Dominick et al., 2012; Tunks
et al., 2008). This is in line with the biopsychosocial theory of pain, which highlights
the importance of taking into account physical and mental health as well as social issues
(Gatchel et al., 2007).
The link between chronic pain and major depressive disorder is especially well
documented, with the overlap in symptoms complicating diagnosis (IsHak et al., 2018).
While both depression and anxiety diagnoses are frequent in patients with chronic pain,
it has been observed that most patients with chronic pain report depressive symptoms.
Patients with chronic pain have also been reported to receive fewer benefits from
antidepressant medication (Roughan et al., 2021) highlighting the role of psychotherapy
in this population.
Comorbid psychopathology has also been shown to interfere with pain rehabilitation
(Dersh, 2002; Fuss et al., 2014), implying psychological treatments could improve
rehabilitation outcomes. Addressing psychological distress in traditional pain rehabilita­
tion settings is often difficult however, mainly due to time and resource constraints.
Although non-drug treatments are common, only a minority of patients in Europe report
having received psychotherapy, and access to multidisciplinary treatments varies (Breivik
et al., 2006, 2013). Further, pain rehabilitation is often conducted in a group format,
limiting treatment individualization, and professionals specializing in pain may lack the
experience to confidently treat psychiatric problems, resulting in comorbid issues going
untreated or patients being excluded from rehabilitation. A potential solution to these
issues is to administer treatment via the internet (Buhrman et al., 2016).
Cognitive behavioral therapy (CBT) aims to reduce distress by teaching concrete
strategies to affect changes in physical sensations, catastrophic thinking and maladaptive
behaviors (Eccleston et al., 2009). Internet-delivered CBT (ICBT) has been found effec­
tive in treating psychiatric problems (Andersson et al., 2013; Buhrman et al., 2015), and
has shown promising results in pain rehabilitation (Buhrman et al., 2016; Eccleston et al.,
2014). Though ICBT can save time and reduce costs (Hedman et al., 2012), a possible
problem with ICBT, which often involves structured self-help texts, is a lack of flexibility.
This can result in exclusion of those with pain and comorbid psychological distress, who
may benefit from treatments covering both pain and the comorbid issues. An alternative
approach is to individually tailor an ICBT program for each patient, combining the
flexibility of traditional face-to-face CBT with the availability and cost-effectiveness of
internet-delivered treatments (Andersson et al., 2011; Kraepelien et al., 2019). This allows
for a treatment that could include patients with a wide range of psychological issues, from
subclinical psychological distress to psychiatric comorbidities.
Due to the limited access and elevated costs of multidisciplinary pain treatments,
ICBT could be a good complement to the chronic pain rehabilitation field. Several studies
have evaluated ICBT for individuals with pain and comorbid psychological distress and
found positive results with effect sizes ranging from small to large when treating
410 N. GASSLANDER ET AL.

comorbid issues such as depression and anxiety (Buhrman et al., 2015; Dear et al., 2013),
depression (O’moore et al., 2018), and insomnia (Kaldo et al., 2015). The tailored
treatment approach is less well studied, though studies have indicated positive effects
on anxiety (Carlbring et al., 2011; Nordgren et al., 2014) and depression (Buhrman et al.,
2015; Johansson et al., 2012; Twomey et al., 2017). Finally, a 2017 meta-analysis found
that tailored ICBT was a promising approach when dealing with comorbidity, with effect
sizes similar to those of disorder specific treatments (Păsărelu et al., 2017).
The present study aims to investigate if a clinician-guided and individually tailored
ICBT can be beneficial in reducing disability and depression in individuals suffering from
chronic pain and comorbid psychological distress. A secondary objective is to determine
whether guided and tailored ICBT can reduce other types of distress such as anxiety,
stress, insomnia and worry.

Methods
Design
A two-armed randomized controlled trial was conducted during the period 2016–2018.
Participants were randomized to either a treatment group or a waiting-list control group,
which was offered the treatment at the conclusion of the post-treatment measurements (3
months after the start of the trial). Written informed consent was collected from all
participants. The study was approved by the regional ethics review board (2016/107), and
was registered at clinicaltrials.gov (NTC03316846).

Procedure
Participants were recruited from a specialist pain clinic at the Uppsala University
Hospital in Sweden. Invitation letters were sent to 2000 patients who constituted
a random selection of patients aged 16–70 years who had visited the pain clinic during
the previous year. The invitations supplied directions to a website with further informa­
tion, as well as an email address where they could apply to participate. After one week, the
majority (randomly selected) of invited patients who had not yet applied were invited by
phone to participate. Unfortunately, due to time constraints, not all invited participants
could be contacted by phone.
Screening consisted of a 30–60 minute structured telephone interview in two parts.
The first part consisted of a 33-question interview that collected demographic data,
assessed inclusion/exclusion criteria, determined general problem areas covered by the
available treatment modules, and gave participants the opportunity to ask questions.
The second part consists of a structured psychiatric screening interview (Mini
International Neuropsychiatric Interview 7.0.0, M.I.N.I, (Sheehan, 2014; Sheehan et al.,
1998) assessing symptoms of psychological distress as defined by the DSM-5. Lastly,
medical file data were retrieved and evaluated by a pain specialist M.D. (T.G.) to
categorize all main pain diagnoses according to ICD-11 (Treede et al., 2019).
The following inclusion criteria were used: Participants had experienced pain for more
than three months and reported at least one form of psychological distress. They had to
have been medically evaluated (as documented in the medical files) regarding their pain
COGNITIVE BEHAVIOUR THERAPY 411

condition during the last year. Further, they needed to have access to a compatible
personal computer with internet access, and be able to read and write Swedish fluently
(since the treatment material was written in Swedish). Participants were excluded if they
were currently undergoing CBT-treatment or planned to do so during the course of the
study, if they had made major changes to their pain- or psychiatric medications during
the last 2 months, had planned surgical interventions during the timeframe of the study,
or reported symptoms of severe depression (>16 points in M.I.N.I. suicide assessment
section with clinical assessment), psychosis (met M.I.N.I. criteria for ongoing psychotic
episode), or substance abuse (met M.I.N.I. criteria for ongoing substance abuse disorder).
Finally, participants who did not manage to log in to the treatment platform for initial
measurements were excluded.
Of the 933 interested individuals, 156 registered interest for the study on the website
and an additional 777 participants were recruited by phone. After screening, 226 indi­
viduals remained and were randomized to either the ICBT (n = 114) or a waiting list
control group (WLC, n = 112). However, after initial compatibility checks and technical
assistance, an additional 39 participants were excluded, leaving 187 eligible participants
(ICBT n = 95, WLC, n = 92) who filled out baseline measures (see Figure 1).
Simple randomization without restriction or stratification was used to select those
who would receive invitation letters, during assignment to treatment or control group, as
well as when assigning a therapist responsible for guiding each participant through the
treatment. Therapists were each assigned an average of 20.7 participants. All randomiza­
tions were carried out using an independent online random number service (http://www.
random.org) to ensure complete randomness.

Participants
A majority of included participants (73%) were female, and the mean age was 45.9 years
(19–64, SD = 11.2). Overall education level was high, with 51% of participants having
completed at least 2 years of university studies. Less than half of all participants (45%)
were currently employed in some capacity. A long history of chronic pain was common
(average of 14.9 years with pain, SD = 10.5) and at least a third (29%) of participants
reported previous participation in pain rehabilitation (in primary or specialist care). All
participants reported symptoms of psychological distress such as worry, depression,
troubled sleep, relationship issues or stress, and over a third of participants met DSM-5
criteria for at least one psychiatric diagnosis. Further participant characteristics are
shown in Table 1.

Intervention procedure
An online treatment platform used in regular care at the Uppsala University Hospital was
used to administer the treatment and collect data. Participants logged in to the secure
treatment platform using two-factor authentication. Once logged in, the participants
were asked to answer initial questionnaires, after which they would gain access to the
treatment material. The platform also included options to download treatment materials
412 N. GASSLANDER ET AL.

Figure 1. Flow of participants through the trial. * Primarily due to technical issues and unreachable
participants.

to their local computers, and participants could contact their assigned therapists at any
time using a secure messaging service on the platform. In case of technical difficulties
participants could contact one of the project leaders who would assist by phone.
Therapists were one licensed psychologist, as well as eight master’s students in their
last semester of a 5-year clinical psychology program. All therapists had completed their
basic CBT training and were supervised by a licensed psychologist and psychotherapist
with experience in treating patients with chronic pain (M.B.).
Both groups filled out online questionnaires during the treatment period. Participants
who did not log in to fill out questionnaires during the appointed week were reminded first
via messages and then via phone calls. All control group participants were invited to
participate in the treatment after having filled out post-treatment measures.
COGNITIVE BEHAVIOUR THERAPY 413

Table 1. Participant characteristics.


Total (n = 187) ICBT (n = 95) WLC (n = 92)
Age (mean [SD]) 45.9 [11.1] 45.6 [11.1] 46.2 [11.2]
Children (mean [SD]) 1.7 [1.4] 1.7 [1.5] 1.7 [1.3]
Daily computer use, hours (mean [SD]) 3 [2.8] 3.1 [2.8] 2.8 [2.7]
Psychiatric diagnoses1 (mean [SD]) 0.9 [1.2] 1.1 [1.4] 0.6 [0.8]
Psychiatric diagnoses2 (n [%])
None 91 [48.7] 41 [43.2] 50 [54.3]
1 58 [31] 28 [29.5] 30 [32.6]
2 20 [10.7] 11 [11.6] 9 [9.8]
3 10 [5.3] 7 [7.4] 3 [3.3]
≥4 8 [4.3] 8 [8.4] 0 [0]
Psychiatric medication3 (n [%]) 81 [43.3] 39 [41.1] 42 [45.7]
Previously received pain rehabilitation (n [%]) 53 [28.5] 35 [36.8] 18 [19.8]
Education (n [%])
9-year compulsory 15 [8] 7 [7.4] 8 [8.7]
Upper secondary 77 [41.2] 35 [36.8] 42 [45.7]
University ≤ 2 years 26 [13.9] 16 [16.8] 10 [10.9]
University > 2 years 69 [36.9] 37 [38.9] 32 [34.8]
Gender (n [%])
Female 137 [73.3] 70 [73.7] 67 [72.8]
Male 50 [26.7] 25 [26.3] 25 [27.2]
Days since last doctor visit (mean [SD]) 72.5 [141.8] 90.6 [186.2] 53.9 [67.7]
In a relationship (n [%]) 132 [70.6] 67 [70.5] 65 [70.7]
Opioid medication (n [%]) 107 [57.2] 51 [53.7] 56 [60.9]
Opioid strength (n [%])4
Weak 35 [32.7] 13 [25.5] 22 [39.3]
Strong 67 [62.6] 34 [66.7] 33 [58.9]
Pain duration, years (mean [SD]) 14.9 [10.4] 15.4 [11.1] 14.3 [9.8]
Pain frequency last month, days (mean [SD]) 30.1 [4.2] 30.4 [2.7] 29.8 [5.3]
Pain categories5 (n [%])
Primary pain 88 [0.5] 48 [0.5] 40 [0.4]
Postsurgical or -traumatic pain 48 [0.3] 20 [0.2] 28 [0.3]
Neuropathic pain 71 [0.4] 34 [0.4] 37 [0.4]
Headache or orofacial pain 12 [0.1] 8 [0.1] 4 [0]
Visceral pain 11 [0.1] 5 [0.1] 6 [0.1]
Musculoskeletal pain 63 [0.3] 32 [0.3] 31 [0.3]
Sick leave last 12 months, days (mean [SD]) 131.2 [151.7] 154.1 [161.4] 109.1 [139.2]
Occupational status (n [%])
Parental leave 3 [1.6] 1 [1.1] 2 [2.2]
Sick leave/compensation* full time (≥100%) 85 [45.5] 47 [49.5] 38 [41.3]
Sick leave/compensation* part time (<100%) 31 [16.6] 10 [10.5] 21 [22.8]
Unemployed full time (≥100%) 8 [4.3] 5 [5.3] 3 [3.3]
Unemployed part time (<100%) 3 [1.6] 2 [2.1] 1 [1.1]
Working/studying full time (≥100%) 51 [27.3] 26 [27.4] 25 [27.2]
Working/studying part time (<100%) 40 [21.4] 17 [17.9] 23 [25]
1. Ongoing diagnoses according to M.I.N.I criteria.
2. MDD (35.8%), GAD (10.2%), PTSD (9.6%), PD (9.1%), SAD (8.0%), AP (7.0%), OCD (3.2%), ME (2.1%), AUD (<1%)
3. Excluding psychiatric medications prescribed for the pain condition only.
4. Percentages of those with opioid medication. Opioid strength judged by medication type, dosage and use frequency as
data allowed (n = 180).
5. Main pain diagnoses according to ICD-11.

One year after the initial treatment, all included participants were asked to fill out the
questionnaires again, and invited to participate in a follow-up booster program.
Interested participants were then randomized to either a one week follow-up or
a longer 5-week booster treatment. At the end of this 5-week period, all participants
were asked to fill out final questionnaires.
414 N. GASSLANDER ET AL.

Table 2. Treatment Modules, Assignment and Completion.


Participant
Assigned evaluation Completed
Module Content n [%]1 mean [SD]2 n [%]3
Introduction Psychoeducation, values and goals. 95 [100] 2.17 [0.92] 84 [88.42]
Relaxation Applied relaxation, short form. 55 [57.89] 2.82 [0.81] 18 [32.73]
Stress coping Stress diary, planning, restoration. 41 [43.16] 2.54 [0.9] 26 [63.41]
Communication Relationship skills, asking for help, assertiveness 37 [38.95] 2.55 [1.15] 20 [54.05]
exercises.
Behavioral Psychoeducation, activity diary, planning, 62 [65.26] 2.55 [1.01] 40 [64.52]
activation 1 activation.
Behavioral Cont. activity diary and planning. Partitioning 62 [65.26] 2.26 [0.86] 34 [54.84]
activation 2 tasks, 5-minute method.
Behavioral Cont. activity diary and planning. Acceptance and 62 [65.26] 2.32 [0.98] 31 [50]
activation 3 mindfulness.
Worry coping 1 Psychoeducation, worry diary, worry time, worry 41 [43.16] 2.06 [1.2] 17 [41.46]
free zones.
Worry coping 2 Types of worry, problem solving techniques. 34 [35.79] 2.64 [1.12] 11 [32.35]
Worry coping 3 Worry hierarchy and exposure exercises. 22 [23.16] 1.17 [0.75] 6 [27.27]
Anxiety and Psychoeducation, behavioral experimentation. 38 [40] 2.65 [0.93] 20 [52.63]
Exposure 1
Anxiety and Anxiety diary, hierarchy, and exposure exercises. 36 [37.89] 2.53 [0.99] 15 [41.67]
Exposure 2
Sleep 1 Psychoeducation, sleep hygiene, sleep diary, 52 [54.74] 2.40 [1.29] 25 [48.08]
goals.
Sleep 2 Cont. sleep diary. Sleep restriction, stimulus 51 [54.74] 2.42 [1.17] 19 [36.54]
control and visualization.
Sleep 3 Cont. sleep diary, stimulus control and sleep 52 [54.74] 2.47 [1.28] 17 [32.69]
restriction. Evaluation and planning.
Trauma 1 Psychoeducation. Trigger analysis and exposure 12 [12.63] 3.40 [0.55] 6 [50]
hierarchy.
Trauma 2 Exposure exercises. Writing exercise. 12 [12.63] 3.00 [0.71] 6 [50]
Trauma 3 Cont. exposure and writing. Troubleshooting and 12 [12.63] 3.00 [1.73] 6 [50]
exposure planning.
Mid-treatment Goal evaluation, maintenance and process 95 [100] 2.68 [1.04] 48 [50.53]
measures.
Maintenance Maintenance, goal evaluation, relapse prevention. 95 [100] 2.63 [1.15] 38 [40]
Total 967 2.45 [1.05] 487 [.50]
1. Number (n) and percentage ([%]) of ICBT patients (n = 95) assigned each module.
2. Participants rated each modules helpfulness on a 0–4 scale after completion, where: 0 = not at all helpful, 4 = very
helpful.
3. Number (n) and percentage ([%]) of assigned ICBT patients who completed the module, where completion was defined
as having sent in all homework exercises.

Intervention
The CBT program was based on a previously evaluated treatment for patients with
chronic pain and depression (Buhrman et al., 2015). It consisted of 6–13 modules,
each designed to be completed in approximately 1 week. The modules included
written information and instructions, concluding with 1–3 exercises meant to be
carried out during the week. Treatment content was mainly presented in the form
of text and images, with audio files provided for some exercises (see, Table 2 for
details). Participants were asked to report the results of their exercises at the end
of each module, and received feedback from their assigned therapists within
24 hours on weekdays, using the secure messaging function. Feedback consisted
of clarifications and answers to questions regarding the treatment, as well as
COGNITIVE BEHAVIOUR THERAPY 415

positive reinforcement of treatment compliance. Text reminders were sent to the


participants who did not send in their assignments on time or showed more than
6 days of inactivity. The reminders were sent to both the treatment platform and
in the form of SMS messages. Participants who did not resume treatment activity
or respond to reminders within 2 days were contacted by phone to improve
treatment adherence.

Individualization/tailoring
A total of 20 treatment modules were created; 17 were used for tailoring while 3 were
mandatory. All participants were assigned the “Introduction” module (which included
practical information, basic psychoeducation and goal setting) as the first module, the
“Mid-treatment” module (focusing on goal evaluation and maintenance) at their indivi­
dual treatment midpoint, and the “Maintenance” module (revisiting maintenance stra­
tegies and goal evaluation) as their last module. Additionally, each participant was
individually assigned 3–9 additional modules, making up the bulk of the treatment
material. This procedure aimed to match participants to treatment modules correspond­
ing to their reported types of distress and was based on the results of the initial interview,
therapist clinical assessment as well as participant preferences. When more modules were
indicated than could fit during the treatment period, clinicians and participants discussed
priorities and made a joint decision. Generally, Behavioral activation 1–3, Sleep 1–3,
Anxiety and Exposure 2, Trauma 1–3 and Worry coping 1 were given higher priority, all
else being equal. Finally, module order was discussed with the participants. Guiding
principles were to keep module sequences intact, place high priority modules early in the
treatment, and to place Behavioral activation and Sleep before Anxiety and Exposure
when possible, following the reasoning that improvements in mood or sleep would
facilitate better adherence to an exposure regimen (see Supplement I for more details
on modules and tailoring process).

Follow up
Twelve-month follow up data was collected from both groups (ICBT, n = 37; WLC,
n = 23). Participants who had completed at least one module of the original treatment
(n = 137) were invited to participate in an additional booster treatment. Interested
participants (n = 66, 48.2%) were randomly assigned to either a 1-week follow up, or
5-week booster treatment. Since the booster treatment was offered to every participant
irrespective of previous treatment adherence, randomization was stratified (using http://
www.random.org) to ascertain an equal number of completers and non-completers in
each group. Before the follow up started, an additional 23 participants were excluded or
declined to participate. Finally, 42 participants remained (1-week follow up, n = 22;
Booster, n = 20) and started follow up (for CONSORT flowchart see Supplement II).
The 1-week follow up included goal evaluation, maintenance planning and relapse
prevention strategies (all of which were also covered by the original treatment material).
The 5-week booster treatment (see Supplement III) consisted of more varied content,
aiming to both rehearse and extend parts of the original program. In addition to the
content of the follow up, the booster treatment included a module on depression and
stress, one on thoughts and worry, and one on emotions and anxiety.
416 N. GASSLANDER ET AL.

Measurement
Measures were obtained at five time points using online self-report questionnaires in the
treatment platform. All measures were collected pre-intervention, post-intervention, at
12-month follow up and after the 5-week booster period. A smaller number of additional
measures (CPAQ, CSQ, and PCS) were collected mid-intervention, though this data is
not utilized in the current analyses.

Primary outcome measures


Montgomery-Åsberg Depression Ration Scale (MADRS-S). MADRS-S is a 9-item self-
report version of a questionnaire measuring depressive symptoms on a scale from 0 to 6.
Internal consistency of the scale has been found to be good, α = .84 (Fantino & Moore,
2009) and the self-report version is consistent with the original clinician rated version
and correlates with other depression scales (r = .87; Bondolfi et al., 2010; Svanborg &
Asberg, 2001). In the present study, the internal consistency was also good, with
a Cronbach’s alpha of .87.

Multidimensional Pain Inventory (MPI-S). The MPI measures psychosocial and beha­
vioral consequences of chronic pain (Kerns et al., 1985). The Swedish version MPI-S
(Bergström et al., 1998), consists of three parts. We used only the first section in the MPI-
S as it is the more stable part, with good psychometric properties. This measure consists
of 22 items and 5 subscales: pain severity, pain interference, life control, affective distress,
and social support. The internal consistency is α = .80 and test-retest coefficients of the
subscales range from r = .74 to .85. Reliability in the present study was acceptable, α = .73.

Secondary outcome measures


Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item questionnaire
measuring symptoms of depression and anxiety on two subscales. In contrast to similar
scales, HADS include no items referring to physical symptoms, reasoning that such
reactions may be attributed to the medical disease or treatment itself (Zigmond &
Snaith, 1983). Psychometric research has shown the latent structure of the HADS to be
unclear, therefore only the total scale is used as a general measure of emotional distress in
the present study (Cosco et al., 2012). Test-retest reliability after 2 weeks is good r = .80
(Lisspers et al., 1997) and reliability in the present study was good, α = .90.

Chronic Pain Acceptance Questionnaire (CPAQ). CPAQ is a 20-item questionnaire


assessing pain acceptance with two subscales: pain willingness and activity engagement.
Items are rated from 0 (“never true”) to 6 (“always true”), and the questionnaire gives
both a total score (0–120) and partial scores; higher results reflect higher pain acceptance
(McCracken et al., 2004). Studies show acceptable reliability (α = .72 to .92) and CPAQ
scores are correlated with measures of avoidance, distress, and daily functioning. Factor
analyses provide support for the 2-factor structure of the scale (Vowles et al., 2008;
Wicksell, Olsson et al., 2009). CPAQ has been validated in an internet sample with
similar psychometric properties to those reported involving paper-and-pencil adminis­
tration (Fish et al., 2010). Internal consistency for the present study was α = .88.
COGNITIVE BEHAVIOUR THERAPY 417

Coping Strategies Questionnaire (CSQ-R). The original CSQ is a 50-item questionnaire


assessing cognitive and behavioral coping strategies (Rosenstiel & Keefe, 1983). In the
present study a revised, 29-item version of the CSQ was used, consisting of seven
subscales: Distracting, catastrophizing, ignoring, distancing, coping self-statements and
praying (Robinson et al., 1997). The Swedish version has a high internal consistency
α = .7 to .8, and the test-retest reliabilities ranging between r = .40 and .90 (Jensen &
Linton, 1993). In the present trial, the internal consistency for the total scale was
acceptable, α = .78.

Pain Catastrophizing Scale (PCS). The PCS consists of 13 statements reflecting thoughts
and feelings that might arise when confronted with pain. The PCS total score (0–52)
provides an index of the catastrophizing construct and can be further divide in three
subscales, with higher scores indicating higher level of pain catastrophizing. The PCS
total scale has good internal reliability, α = .92 (Wheeler et al., 2019), but due to the
subscales having lower reliability, only the total score was used in this study. In the
present trial, the internal consistency was good for the total scale at α = .91.

Quality of Life Inventory (QOLI). QOLI consists of 32 items assessing life satisfaction.
The assessment yields an overall score and profile in 16 areas of life; health, self-esteem,
goals and values, money, work, play, learning, creativity, helping, love, friends, children,
relatives, home, neighborhood, and community. Each item is rated in terms of impor­
tance (0 = not at all important to 2 = extremely important) and satisfaction (−3 = very
dissatisfied to 3 = very satisfied). QOLI has been found to show adequate stability over
time with test-retest coefficients ranging between r = .80 and .91. The internal consistency
coefficients ranged from α = .77 to .89 across 3 clinical and 3 nonclinical samples. In the
present study, the internal consistency was acceptable, α = .84. QOLI has further been
validated in internet samples with similar psychometric properties to those reported
involving paper-and-pencil administration (Carlbring et al., 2007; Lindner et al., 2013).

Anxiety Sensitivity Index (ASI). ASI is a 16-item questionnaire that measures fear of
anxiety symptoms, which are rated from 0 to 4. Higher scores indicate a higher degree of
fear. ASI has a good construct validity and adequate 2-week test-retest reliability, r = .74.
The internal consistency is also good, α = .88 (Rodriguez et al., 2004). The reliability for
this questionnaire in the present sample was good, α = .91.

Pain Disability Index (PDI). The PDI is a 7-item scale measuring the degree to which
pain interferes with functioning across a range of activities. The seven different areas
measured are: home/family responsibilities, social activities, recreation, occupation, sex­
ual behavior, self-care, and life-support activity. Every item score can range from 0 (“no
interference”) to 10 (“total interference”), resulting in a total score from 0 to 70, with
higher scores indicating more interference (Tait et al., 1987). The internal consistency has
been reported to be good in several studies, α = .86 (Soer et al., 2015, 2013; Tait et al.,
1990). The more recent studies states that using the PDI as a 1-factor questionnaire is
preferred (Soer et al., 2015, 2013). In the present trial, the internal consistency was
acceptable, α = .82.
418 N. GASSLANDER ET AL.

Pain Self-Efficacy Questionnaire-2 (PSEQ-2). The original PSEQ is a 10-item measure


of pain self-efficacy; an individual’s belief that they can carry out daily activities despite
experiencing pain. It has been shown to predict disability as well as attrition and work
capacity. In this study, a two-item version was used. This version has shown an adequate
internal consistency of α = .76 and test-retest reliability of r = .76 (Nicholas et al., 2015).
In the present trial, internal consistency was α = .80.

Tampa Scale of Kinesiophobia (TSK-11). The TSK-11 is a 17-item questionnaire that


measures fear of movement and (re)injury (Miller et al., 1991). Each item is scored from 1
(“strongly disagree”) to 4 (“strongly agree”). The total score ranges from 17 to 68 points,
with higher scores signifying greater fear of re-injury due to movement (Woby et al.,
2005). Internal consistency range from α = .74 to .87 in a Swedish sample, and test-retest
is good, r = .75 (Larsson et al., 2014). The reliability in the present trial was acceptable,
α = .79.

Secondary additional and elective outcomes


The ISI, SMBQ, PCL-5 and GAD-7 questionnaires were administered only if the parti­
cipants were allocated to a treatment module related to the respective questionnaires area
of inquiry, whereas the TCS was administered to all participants at pre-treatment only.

Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire assessing the nature,
severity and impact of insomnia. The dimensions included in ISI are severity of sleep
onset, sleep maintenance, early awakening problems, sleep dissatisfaction, interference
with daytime functioning, noticeability of sleep problems by others, and distress caused
by sleep difficulties. A 5-point Likert scale is used to rate each item yielding a total score
from 0 to 28, with higher scores indicating more severe insomnia (Bastien et al., 2001).
Internal consistency has been reported as very good, α = .90–.91 (Morin et al., 2011) and
in the present trial the internal consistency was good, α = .81.

Shirom-Melamed Burnout Questionnaire (SMBQ). A 22-item questionnaire measuring


consequences of prolonged stress (Melamed et al., 1992). The items are rated a scale from
1 (“almost never”) to 7 (“almost always”), and the total score is computed as an average of
the 22-items resulting in a score of 1–7, where higher scores indicate higher levels of
stress, and a score ≥4 indicates clinically significant burnout. Internal consistency has
been reported as very good, α = .91 (Melamed et al., 1999), and in the present trial the
internal consistency of SMBQ was equally good at α = .94.

PTSD Checklist—fifth edition (PCL-5). The PCL-5 is a questionnaire comprising 20


items that measure the key symptoms of post-traumatic stress disorder (PTSD) as
defined by the DSM-5. Responders rate each item from 0 (not at all) to 4 (extremely)
to indicate the degree to which they have been bothered by that particular symptom over
the past month. Scores range from 0 to 80 where higher scores indicate higher degree of
PTSD symptoms. Test-retest reliability has been reported as .82 at 1 week and internal
consistency has been shown to be high at α = .94 (Blevins et al., 2015). In the present
sample, the internal consistency was also good, α = .95.
COGNITIVE BEHAVIOUR THERAPY 419

Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item anxiety and worry
scale. Scores range from 0 (“not at all”) to 3 (“nearly every day”) and the total score ranges
from 0 to 21 where higher scores indicate more severe symptoms. Scores above 10 are
considered to be in the clinical range (Spitzer et al., 2006). Internal consistency is good
across different samples, α = .89 (Löwe et al., 2008). In the present sample, the internal
consistency was α = .86.

Treatment credibility Scale (TCS). The TCS is a 5-item scale adapted from Borkovec
and Nau (1972). Items such as, “How logical does the treatment seem to you?” were rated
from 0 to 10 (Borkovec & Nau, 1972). The internal consistency is good, α = .84–.85 and
the test-retest reliability is also acceptable, r = .75–.82 (Devilly & Borkovec, 2000). In the
present study, the internal consistency was high at α = .96.

Analysis
Analyses were carried out using SPSS version 26. The intention-to-treat principle was
used with all available data regardless of completion of the actual treatment. Missing data
was imputed with the expectation-maximization method. This method computes miss­
ing values based on maximum likelihood estimates with observed data in an iterative
process (Blankers et al., 2010). No data were missing at baseline but 30.7% of data were
missing at post-intervention due to a combination of unanswered items and participant
attrition. These missing values at post-intervention were imputed using SPSS multiple
imputation procedure. A comparison of results based on the imputed intention-to-treat
sample versus the observed data resulted in similar outcomes. Results from the intention
to-treat analyses are reported when observed data and ITT does not differ, and when
there is a difference both results are presented
Comparisons were two-tailed and interpreted with an alpha of .05. Analysis of
covariance (ANCOVA) was used to analyze data. The method adjusts for pretest scores.
Data from the self-report measures were checked for normality assumptions and found
suitable for parametric analyses.
Cohen’s d was used to calculate the within- and between-group effect sizes at post-
intervention. Effect sizes of 0.20–0.50 were considered small, 0.50–0.80 as moderate, and
>0.80 as large (Cohen, 1988). To assess clinical significance, the number of participants
reporting improvements from pre to post of ≥30% was computed for all measures showing
statistically significant interaction effects. These frequencies were then compared between
groups using χ2 tests. Follow up data at 12 months was obtained for the treatment group
and analyzed with paired samples t-test. Pre-treatment group differences in demographic
data were analyzed with t-test and χ2 was used for categorical variables.
Power was estimated from previous ICBT effect sizes for health problems (Cuijpers
et al., 2008) and assuming a between-group effect size of d = 0.80 would require 80
individuals to establish an effect at p < .05 (Cohen, 1988). The aim was to include at least
120 participants to handle a higher level (n = 40) of attrition.
420 N. GASSLANDER ET AL.

Results
Primary outcomes
Primary outcomes were depression, as measured by MADRS, and pain disability
measured with the Pain Interference subscale of the MPI-S. Using ANCOVA to
adjust for baseline values, significant differences between the groups were observed at
post-treatment, indicating superiority of ICBT over the WLC-condition on both the
MADRS, F (1) = 13.7, p < .001, d = 0.18 (95% CI 0.46, −0.11), and the MPI Pain
Interference scale, F (1) = 9.41, p = .002, d = 0.22 (95% CI 0.5, −0.07). See, Table 3.
T-tests showed all significant changes on primary outcomes to remain significant from
pretreatment to 12-month follow up. Further analysis indicated changes in primary
outcomes to be stable or improved from posttreatment to the 12-months follow up.
On the MADRS an additional significant improvement was detected (t (30) = −2.34,
p = 0.026), while the rest of the outcomes showed no significant improvement or
deterioration in the treatment group. Regarding the booster treatment, ANCOVA
showed no significant differences between the groups at post-treatment on any of the
primary outcomes, indicating no significant improvement or deterioration after partici­
pating in the booster treatment.

Secondary and elective outcomes


ANCOVA showed significant differences between the groups at post for the HADS,
F (1) = 8.91, p = .003, d = 0.19 (95% CI 0.47, −0.1), as well as the MPI-S subscale Life
Control, F (1) = 5.73, p = .018, d = 0.1 (95% CI 0.39, −0.19), mirroring the results of the
primary outcomes.
The treatment was also shown to have a significant effect on pain acceptance as
measured by the CPAQ, F (1) = 8.26, p = .005, d = 0.3 (95% CI 0.58, 0.01).
Significant changes in coping strategies were observed on the CSQ subscales Ignoring,
F (1) = 4.21, p = .042, d = 0.34 (95% CI 0.63, 0.05) and Catastrophizing, F (1) = 12.23,
p = .001, d = −0.15 (95% CI 0.44, −0.14), both in favor of the treatment group.
Additionally, significant effects on quality of life were obtained on the QOLI,
F (1) = 11.85, p = .001, d = 0.02 (95% CI 0.31, −0.26). See, Table 4 for all secondary results.
Analyses of the observed data also showed significant results for the PCS (F (1) = 3.98,
p = 0.048), and the MPI subscale Pain Severity (F (1) = 3.57, p = 0.061). However, these
results were not significant in the ITT-analyses.
Finally, ANCOVA analyses of the observed data also showed significant results for the
SMBQ (F (1) = 10.66, p = 0.002) and the ISI (F (1) = 5.66, p = 0.019). However, these
results were not significant in the ITT-analyses. Table 5 for details.
T-tests showed all significant effects of time on secondary outcomes to remain
significant from pretreatment to 12-month follow up. All significant changes in second­
ary outcomes were stable over time, showing no significant improvement or deteriora­
tion from posttreatment to 12-months follow up. Regarding the booster treatment,
ANCOVA showed no significant differences between the groups (post-booster treat­
ment) on any of the secondary outcomes.
Table 3. Means, standard deviations, effect sizes (Cohen’s d) for the two groups on primary outcomes.
ES ES ES
between within ICBT within ICBT
Pre-treatment Post-treatment1 12 month follow up at post pre-post pre-12 m ANCOVA2
Measures n Mean [SD] n Mean [SD] n Mean [SD] d [95% CI] d [95% CI] d [95% CI] df F p
MADRS
ICBT 95 20.48 [9.53] 95 17.61 [10.47] 37 15.16 [9.54] 0.18 [0.46; −0.11] 0.29 [0.57; 0] 0.56 [0.94; 0.17] 1 13.7 0.000
WLC 92 18.45 [8.06] 92 19.29 [8.55] 22 16.23 [9.46]
MPI-S Pain Interference
ICBT 95 4.38 [1.11] 95 3.96 [1.22] 37 3.76 [1.39] 0.22 [0.5; −0.07] 0.36 [0.64; 0.07] 0.52 [0.9; 0.13] 1 9.4 0.002
WLC 92 4.27 [0.98] 92 4.2 [1.04] 22 3.31 [1.54]
ANCOVA, Analysis of covariance; MADRS, Montgomery-Åsberg Depression Rating Scale; MPI, Multidimensional Pain Inventory
1. Post-treatment values include imputed data which affect all post-treatment means, standard deviations and effect sizes.
2. With post-treatment scores as dependent variable and pre-treatment scores as covariate.
COGNITIVE BEHAVIOUR THERAPY
421
422 N. GASSLANDER ET AL.

Effects sizes and clinical significance


Between-group effect sizes at posttreatment ranged from very small (<0.20) to small
(≥0.20). A very small between-group effect size from pre to post was found for the
MADRS, while a small between-group effect size was observed for the Pain Interference
(MPI-S) scale. Within-group effect sizes were small for both primary outcomes, and from
pretreatment to 12-months follow up, moderate (≥0.50) within-group effect sizes were
observed for both scales. Effect sizes for primary outcomes are shown in Table 3.
Similarly, very small between-group effect sizes post-treatment were found for the
secondary outcomes for mood (HADS), Catastrophizing (CSQ) and Quality of Life
(QOLI), while both the Ignoring (CSQ) and Pain Acceptance scales (CPAQ) showed
small (≥0.2) effects. Effect sizes for secondary outcomes are shown in Table 4.
At posttreatment, 24 ICBT participants (35.8%) reported at least a 30% decrease in
depression scores on the MADRS, compared to eight participants in the control group
(10.7%). This difference was significant (χ2 = 8, p = .0047, NNT = 3.98). The same was
true for the Pain Interference scale of the MPI-S where 11 ICBT-participants (16.4%)
reached a 30% improvement compared to two (2.7%) in the control group (χ2 = 6.23,
p = .0126, NNT = 7.29).

Treatment adherence, attrition, and satisfaction


Of the 187 participants, 140 (74.9%) completed all their post-treatment measurements
and a total of 30.7% of data were missing at post. A total of 57 participants (30.5%)
completed the 12-month follow-up measurements. At inclusion, participants were
assigned an average of 10.2 modules (SD = 1.74) of which they completed an average
of 5.1 (SD = 3.79). Overall, out of the 967 assigned modules, 487 (50.4%) were fully
completed, and 23.2% (n = 22) of the participants in the treatment group fully completed
all modules they were assigned.
To compare characteristics of treatment completers and non-completers, ICBT
participants were divided into two groups, where those who completed at least 75%
of their assigned modules were counted as “completers”. Of the 95 participants in
the treatment group, 33 (34.7%) completed at least 75% of their assigned modules,
while 62 (65.3%) completed less than 75%. Comparing the groups on demographic
characteristics indicated that the completer-group contained significantly more par­
ticipants with a primary pain diagnosis (χ2 = 7.43, p < .01), whereas participants in
the drop-out group had a significantly larger amount of sick days during the
last year (t [74] = 2.06, p = .04). Comparing the two groups on pre-treatment
measures yielded further significant differences, with the drop-out group showing
significantly lower values of pain acceptance (CPAQ, t [93] = −2.43, p = 0.02), pain
self-efficacy (PSEQ, t [93] = −2.7, p < 0.01), quality of life (QOLI, t [92] = −2.64,
p = 0.01) and treatment credibility (TCS, t [92] = −2.82, p < 0.01), while also
showing significantly higher values on scales of depression (MADRS, t [93] = 3.31,
p < 0.01), psychological distress (HADS, t [93] = 2.16, p = 0.03), pain interference
(MPI Interference, t [93] = 2.46, p = 0.02), pain disability (PDI, t [92] = 2.89,
Table 4. Means, standard deviations, effect sizes (Cohen’s d), for the two groups on secondary outcomes.
ES ES ES
between within ICBT within ICBT
Pre-treatment Post-treatment1 12 month follow up at post pre-post pre-12 m ANCOVA2
Measures n Mean [SD] n Mean [SD] n Mean [SD] d [95% CI] d [95% CI] d [95% CI] df F p
HADS
ICBT 95 17.52 [8.85] 95 15.65 [9.3] 37 12.76 [8.51] 0.19 [0.47; −0.1] 0.21 [0.49; −0.08] 0.54 [0.93; 0.16] 1 8.91 0.003
WLC 92 16.61 [7.17] 92 17.23 [7.6] 22 14.77 [8.72]
MPI-S Affective distress
ICBT 95 3.1 [0.72] 95 2.91 [0.82] 37 2.66 [1] 0.18 [0.47; −0.11] 0.24 [0.53; −0.04] 0.55 [0.93; 0.16] 1 2.69 0.103
WLC 92 3 [0.71] 92 3.05 [0.67] 22 3.05 [0.89]
MPI-S Life control
ICBT 95 2.43 [1.1] 95 2.79 [1.29] 37 3.14 [1.29] 0.1 [0.39; −0.19] 0.3 [0.59; 0.02] 0.62 [1.01; 0.23] 1 5.73 0.018
WLC 92 2.85 [1.05] 92 2.68 [0.94] 22 3.23 [1.3]
MPI-S Pain severity
ICBT 95 4.04 [0.82] 95 3.75 [1.02] 37 3.77 [0.97] 0.13 [0.42; −0.16] 0.31 [0.6; 0.02] 0.31 [0.69; −0.07] 1 2.75 0.099
WLC 92 3.93 [1.08] 92 3.88 [1.02] 22 3.05 [1.14]
MPI-S Social support
ICBT 95 3.58 [1.72] 95 3.65 [1.78] 37 3.64 [1.71] 0.28 [0.56; −0.01] 0.04 [0.33; −0.24] 0.03 [0.41; −0.35] 1 0.05 0.831
WLC 92 4.06 [1.4] 92 4.11 [1.51] 22 3.95 [1.57]
CPAQ
ICBT 95 51.49 [19.36] 95 58.05 [21.19] 38 61.18 [23.15] 0.3 [0.58; 0.01] 0.32 [0.61; 0.04] 0.47 [0.85; 0.09] 1 8.26 0.005
WLC 92 50.59 [17.69] 92 52.16 [18.52] 23 63.26 [20.77]
CSQ: Catastrophizing
ICBT 95 13.73 [5.4] 95 11.9 [6.02] 37 10.68 [6.48] 0.15 [0.44; −0.14] 0.32 [0.61; 0.03] 0.53 [0.92; 0.15] 1 12.23 0.001
WLC 92 12.39 [5.29] 92 12.75 [5.32] 23 9.98 [4.98]
CSQ: Coping-self-statements
ICBT 95 11.23 [3.87] 95 11.35 [3.74] 37 10.83 [3.9] 0.38 [0.67; 0.09] 0.03 [0.31; −0.25] 0.10 [0.48; −0.28] 1 2.02 0.157
WLC 92 9.94 [3.19] 92 9.91 [3.8] 23 9.48 [3.37]
CSQ: Distancing
ICBT 95 5.62 [4.93] 95 5.57 [4.95] 37 5.32 [5.44] 0.22 [0.5; −0.07] 0.01 [0.29; −0.28] 0.06 [0.44; −0.32] 1 0.46 0.501
WLC 92 3.7 [4.22] 92 4.56 [4.28] 23 3.23 [3.84]
CSQ: Distracting
ICBT 95 11.31 [4.61] 95 11.34 [5.22] 37 12.7 [5.09] 0.091 [0.38; −0.2] 0.01 [0.29; −0.28] 0.29 [0.67; −0.09] 1 1.74 0.189
WLC 92 11.66 [4.79] 92 10.86 [5.24] 23 12.14 [5.79]
COGNITIVE BEHAVIOUR THERAPY

CSQ: Ignoring
ICBT 95 10.63 [4.49] 95 11.09 [5.05] 37 10.7 [4.9] 0.34 [0.63; 0.05] 0.1 [0.38; −0.19] 0.02 [0.4; −0.36] 1 4.21 0.042
WLC 92 9.89 [4.57] 92 9.43 [4.73] 23 9.9 [3.81]
(Continued)
423
424

Table 4. (Continued).
ES ES ES
between within ICBT within ICBT
1
Pre-treatment Post-treatment 12 month follow up at post pre-post pre-12 m ANCOVA2
Measures n Mean [SD] n Mean [SD] n Mean [SD] d [95% CI] d [95% CI] d [95% CI] df F p
CSQ: Praying
N. GASSLANDER ET AL.

ICBT 95 4.59 [4.59] 95 4.24 [4.05] 37 4.25 [4.88] 0.21 [0.5; −0.08] 0.08 [0.37; −0.2] 0.07 [0.45; −0.31] 1 0.19 0.664
WLC 92 3.58 [4.27] 92 3.35 [4.33] 23 2.67 [3.61]
PCS
ICBT 94 22.5 [9.93] 95 19.69 [10.86] 37 17.49 [10.72] 0.03 [0.32; −0.26] 0.27 [0.56; −0.02] 0.49 [0.88; 0.11] 1 1.75 0.188
WLC 92 21.11 [9.44] 92 20.01 [9.63] 22 17.77 [8.76]
QOLI
ICBT 94 0.3 [1.99] 94 0.77 [2.13] 37 1.29 [2.01] 0.02 [0.31; −0.26] −0.23 [0.51; −0.06] −0.49 [0.88; 0.11] 1 11.85 0.001
WLC 91 0.95 [1.62] 91 0.82 [1.77] 22 1.38 [2.06]
ASI
ICBT 95 19.85 [12.69] 95 16.54 [10.37] 37 12.41 [7.95] 0.01 [0.29; −0.28] 0.29 [0.57; 0] 0.64 [1.03; 0.26] 1 1.23 0.269
WLC 92 18.07 [10.29] 92 16.47 [9.32] 23 14.26 [7.21]
PDI
ICBT 94 41.37 [12.68] 94 38.59 [13.09] 37 35.84 [14.07] 0.03 [0.32; −0.26] 0.22 [0.5; −0.07] 0.42 [0.81; 0.04] 1 1.4 0.238
WLC 91 39.26 [10.31] 91 38.21 [10.84] 22 31.55 [13.81]
PSEQ-2
ICBT 94 6.33 [3.59] 95 6.28 [3.41] 37 6.95 [3.88] 0.07 [0.35; −0.22] 0.01 [0.3; −0.27] 0.17 [0.55; −0.21] 1 0.47 0.495
WLC 91 6.16 [3.28] 91 6.5 [3.07] 22 8.5 [2.91]
TSK
ICBT 94 37.21 [8.05] 94 36.45 [8.72] 37 36.03 [9.06] 0.14 [0.43; −0.15] 0.09 [0.38; −0.2] 0.14 [0.52; −0.24] 1 0.45 0.506
WLC 90 36.36 [8.42] 90 35.28 [7.66] 22 32.09 [8.6]
ANCOVA, Analysis of covariance; HADS, Hospital Anxiety and Depression Scale; MPI, Multidimensional Pain Inventory; CPAQ, Chronic Pain Acceptance Questionnaire; CSQ, Coping Strategies
Questionnaire; PCS, Pain Catastrophizing Scale; QOLI, Quality Of Life Inventory; ASI, Anxiety Sensitivity Index; PDI, Pain Disability Index; PSEQ, Pain Self-Efficacy Questionnaire; TSK, Tampa Scale
of Kinesiophobia
1. Post-treatment values include imputed data which affect all post-treatment means, standard deviations and effect sizes.
2. Using post-treatment scores as dependent variable and pre-treatment scores as covariate.
Table 5. Means, standard deviations, effect sizes (Cohen’s d), for the two groups on elective symptom outcomes.
ES ES ES
between within ICBT within ICBT
Pre-treatment Post-treatment2 12-month follow up at post pre-post pre-12 m ANCOVA3
1
Measures n Mean [SD] n Mean [SD] n Mean [SD] d [95% CI] d [95% CI] d [95% CI] df F p
ISI
ICBT 75 17.92 [5.44] 75 15.75 [6.36] 22 13.95 [6.09] 0.03 [0.35; −0.3] 0.37 [0.69; 0.04] 0.71 [1.19; 0.22] 1 1.66 0.200
WLC 71 16.86 [5.36] 71 15.93 [5.57] 15 12.07 [7.93]
SMBQ
ICBT 66 4.77 [1.14] 66 4.6 [1.22] 28 3.99 [1.15] 0.06 [0.41; −0.28] 0.15 [0.49; −0.19] 0.69 [1.14; 0.23] 1 2.39 0.124
WLC 65 4.59 [1.09] 65 4.67 [1.1] 17 4.19 [1.48]
GAD-7
ICBT 65 8.31 [5.07] 65 6.41 [4.26] 6 7.67 [5.82] 0.2 [0.53; −0.14] 0.41 [0.75; 0.06] 0.13 [0.96; −0.71] 1 2.77 0.098
WLC 70 7.71 [4.6] 70 7.22 [4.01] 15 7 [5.99]
PCL-5
ICBT 37 28.68 [19.12] 37 27.19 [17.14] 14 25.14 [15.19] 0.33 [0.8; −0.15] 0.08 [0.54; −0.37] 0.2 [0.81; −0.42] 1 0.10 0.749
WLC 32 21.75 [14.62] 32 21.93 [15.01] 8 29.38 [19.12]
ANCOVA, Analysis of covariance; ISI, Insomnia Severity Index; SMBQ, Shirom-Melamed Burnout Questionnaire; GAD-7, Generalized Anxiety Disorder 7-item questionnaire; PCL-5, PTSD Checklist-
5th edition
1. Only participants who reported the relevant problems were asked to complete respective measures.
2. Post-treatment values include imputed data which affect all post-treatment means, standard deviations and effect sizes.
3. Using post-treatment scores as dependent variable and pre-treatment scores as covariate.
COGNITIVE BEHAVIOUR THERAPY
425
426 N. GASSLANDER ET AL.

p < 0.01), and kinesiophobia (TSK, t [92] = 3.79, p < 0.01). See Supplement IV for
details. Further analyses of adherence has been published separately (Gasslander
et al., 2021).
The modules were generally evaluated as helpful by the participants with a mean score
of 2.45 (SD = 1.05) on a 0–4 scale where 0 = “not at all helpful” and 4 = “very helpful”
(see, Table 2 for details). Out of the 20 participants who started the booster treatment, 7
(35%) completed all modules, and participants completed on average 2.55 (51%) of the 5
booster modules. The booster modules were also positively evaluated with a mean score
of 2.92 (SD = 1.25).

Discussion
The purpose of the present study was to investigate whether an individually tailored
ICBT program would be beneficial for individuals suffering from chronic pain and
comorbid psychological distress. Treatment was delivered via the internet and guided
by therapists. Significant improvements were found in the primary outcomes measuring
depression (MADRS), and disability (MPI-S Pain Interference). Unexpectedly, no effects
on disability could be detected on the PDI. This is especially surprising since the content
of the PDI and the MPI Pain Interference scales are very similar. Given the small effect
sizes, one explanation could simply be a lack of power.
Moreover, significant improvements favoring the ICBT-group were observed for
another of the MPI subscales (MPI-S Life Control), as well as emotional distress
(HADS). The treatment group also demonstrated improvements regarding catastrophiz­
ing, as measured with the CSQ, which is in line with our previous studies (Buhrman et al.,
2013). Surprisingly, no similar effects on was observed on the PCS. When analyses were
done per protocol, a significant effect was observed in the PCS but this effect could not be
observed in the ITT analyses. Compared to the CSQ which is measure of global
catastrophizing that frames its questions as strategies and focuses on helplessness, the
PCS includes twice as many items and incorporates a broader definition of catastrophiz­
ing including several domains, which might not capture the change affected by the ICBT-
treatment.
We could also detect significant interaction effects on the pain-acceptance question­
naire CPAQ. In the present study, the Quality of Life Inventory (QOLI) showed
a significant effect in favor of the treatment group, this differs from our previous trials
where no significant effects were found on the QOLI (Buhrman et al., 2013, 2015). Effect
sizes for all significant results ranged from very small to small and follow-up data showed
that outcomes to be stable over time, with no significant positive or negative changes
from post-treatment to one year follow up.
No significant effects were found in the anxiety outcome (ASI), which was somewhat
surprising. In our previous individualized treatment for chronic pain patients with
comorbid depression and anxiety (Buhrman et al., 2015), while the changes in ASI
were not significant, there was a significant effect on one of the anxiety outcomes. One
explanation for the result in the present trial could be that few modules focused on
anxiety and exposure, with a majority of modules focused on behavioral activation and
cognitive techniques to handle worry. This might also be a potential reason for the lack of
effects on the TSK, a scale measuring fear of movement.
COGNITIVE BEHAVIOUR THERAPY 427

Overall, the results from this study are in line with previous research examining internet-
based treatment for chronic pain and comorbidity (Buhrman et al., 2015; Dear et al., 2013).
The present trial differs from Dear et al. (2013) in that the treatment was tailored. Compared
to our previous trial (Buhrman et al., 2015) this study differs in inclusion criteria. The present
trial did not only include participants with depression and anxiety problems but also other
psychiatric disorders such as PTSD and GAD. Participants were recruited from a specialist
clinical setting and reported a variety of chronic pain conditions in addition to their
psychiatric conditions. Participants reported experiencing pain for an average of
14.9 years, 31% reported at least one psychiatric disorder and 43% reported taking prescribed
psychotropics. Furthermore, 57% reported opioid use and the majority was on sick leave.
Consequently, this is a sample of patients with heterogeneous and complex chronic pain
problems and high emotional comorbidity. Furthermore, the treatment in this study con­
sisted of an extensive selection of modules (n = 20) that could be selected to individualize the
treatment to the participants. Participants were thus able to influence which modules they
were assigned. While it is difficult to individualize treatment for chronic pain patients in
clinical settings, tailoring offers the possibility to meet the participant in their present
difficulties and focus on their primary problems. However, more research is needed to
understand the essential components of effective internet-based programs. Chronic pain is
often associated with social and psychological burden and according to the biopsychosocial
approach an understanding of when and for whom these programs are effective is essential
to guide the integration of internet-based pain treatment into existing health-care systems.
Adherence is an important issue to discuss in ICBT trials. In the present trial, 22.9%
(n = 22) completed all modules they were assigned, with participants in the treatment
group completing on average 51% of their treatment program. Analysis of attrition
showed, unsurprisingly, that those who dropped out to have significantly higher levels
of disability, depression and psychological distress, as well as lower pain acceptance.
Adherence in a clinical setting is a challenge. One meta-analysis showed (Van
Ballegooijen et al., 2014) that participants in face-to-face CBT completed on average
83.9% of their treatment, which did not differ significantly from participants in guided
ICBT (80.8%, p = .59). Non-completers of guided ICBT followed on average 42.1% of
their treatment programs before they dropped out, while non-completers of face-to-face
CBT followed 24.5% of their treatment programs. In the present trial, the intervention
consisted of 6–13 sessions and the treatment group completed on average 5.1 sessions,
which is in line with findings from the meta-analyses conducted by Van Ballegooijen
et al. (2014). Several factors may explain adherence to internet interventions; guidance,
study design, regularity of updates to the intervention website and persuasive technology
(Van Ballegooijen et al., 2014). The present trial was guided and the majority of the
participants experienced the intervention as beneficial, a factor which is associated with
better adherence. As mentioned earlier, this was a clinical sample with high levels of
comorbidity and it is possible that the guidance needs to be more intensive and maybe
these participants could benefit from more time to complete the program, i.e. a more
low-intensive treatment.
Limitations that should be mentioned is that while participants were recruited from
a clinical setting, they were still self-recruited, which may have caused some individuals
to decline participation because of unfamiliarity with the internet. Several participants
stated IT-issues as their reason for declining participation or dropping out. Further, some
428 N. GASSLANDER ET AL.

differences between groups at baseline were observed, with the control group reporting
fewer ongoing psychiatric diagnoses, better social support and higher quality of life,
which could potentially have skewed the results. An explanation for this could be
differential dropout between randomization and pre-treatment measures, with some
participants with more severe symptoms dropping out as they realized they were in the
control condition. The control condition was a waiting-list and it would be preferable to
use credible intervention alternatives. However, individuals in the control group were not
restricted in their use of other health-care options while on the waiting list. In the present
trial CPAQ was used as an outcome variable. CPAQ is often used to investigate processes
of change during treatment (McCracken & Eccleston, 2005), and the present study design
focus was on investigating change in acceptance of pain. Lack of detailed data on
therapist hours is another limitation (though rough estimates show therapists spent
around 100 minutes/participant). Another important limitation was the low uptake
rate and the drop-out level (23%) which was considerable.
In spite of the limitations there are several strengths that are important to mention.
Unlike many previous CBT-interventions for chronic pain (Eccleston et al., 2013; Vowles
& McCracken, 2008; Wicksell, Melin et al., 2009), the present trial was a stand-alone
psychological treatment without multidisciplinary components. This is important, since
multidisciplinary rehabilitation is associated with high costs and rehabilitation clinics are
often unavailable to individuals in rural areas. Internet-delivered treatments could be
used as a cost-effective complement; it would offer the opportunity to reach more
individuals with chronic pain and psychological distress, and it offers the possibility to
individualize treatment to suit the individuals’ main complaints (Andersson, 2009, 2014;
Hedman et al., 2011). A recent trial showed that internet delivered pain management
programs with different levels of clinician support can be highly cost-effective for patients
with chronic pain (Dear et al., 2021). Finally, previous research has indicated that some
participants who show residual symptoms after pain rehabilitation can benefit from
additional treatment (Buhrman et al., 2013). With this in mind, we offered a booster
treatment at 12-month follow up. Around half of those we asked (n = 66, 48.2%) showed
interest in this booster-treatment, and the content was generally judged to be helpful by
the participants, indicating a possible role for this type of intervention. Though our
analyses found no significant improvement or deterioration in booster treatment parti­
cipants compared to those who received a more basic follow up, high attrition and lack of
further follow up limit the conclusions that can be drawn from these data.
Future studies should investigate the effects of internet-based treatments for chronic
pain with psychiatric comorbidity relative to credible intervention alternatives. There is
also a need to study health economic variables for this type of treatment for chronic pain
since long-term sick leave is a common consequence of chronic pain. Internet-based
interventions are not helpful for all individuals with chronic pain, and future research
should investigate who benefits most from this kind of intervention. More research is also
needed to understand adherence and individualization to internet interventions from the
participant’s perspective.
We conclude that a tailored ICBT program for individuals with chronic pain and
psychological distress shows promise as a viable treatment option in the management of
chronic pain.
COGNITIVE BEHAVIOUR THERAPY 429

Acknowledgments
We thank the Multidisciplinary Pain Centre at Uppsala University Hospital for the support during
the trial.

Disclosure statement
No potential conflict of interest was reported by the author(s).

Funding
This research was funded by Uppsala University and AFA Insurance.

ORCID
Nils Gasslander https://orcid.org/0000-0002-3722-5225
Gerhard Andersson https://orcid.org/0000-0003-4753-6745
Frida Boström https://orcid.org/0000-0001-7781-676X
Lisa Brandelius https://orcid.org/0000-0003-0387-2683
Lotta Pelling https://orcid.org/0000-0001-6773-7427
Lovisa Hamrin https://orcid.org/0000-0002-2089-1133
Torsten Gordh https://orcid.org/0000-0003-1454-3148
Monica Buhrman https://orcid.org/0000-0002-1722-3505

Significance
This randomized controlled trial of an individually tailored internet-delivered cognitive-
behavioral therapy showed significant improvements in several measures of comorbid psy­
chological distress for participants with chronic pain recruited from a specialist pain clinic.

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