Psychotherapy Research

ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/tpsr20

Effectiveness of the Unified Protocol for

transdiagnostic treatment of emotional disorders
in group format in Spain: Results from a
randomized controlled trial with 6-months follow-
up

J. Osma, O. Peris-Baquero, C. Suso-Ribera, T. J. Farchione & D. H. Barlow

To cite this article: J. Osma, O. Peris-Baquero, C. Suso-Ribera, T. J. Farchione & D. H. Barlow

(2021): Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders
in group format in Spain: Results from a randomized controlled trial with 6-months follow-up,
Psychotherapy Research, DOI: 10.1080/10503307.2021.1939190

To link to this article: https://doi.org/10.1080/10503307.2021.1939190

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Psychotherapy Research, 2021
https://doi.org/10.1080/10503307.2021.1939190

EMPIRICAL PAPER

Effectiveness of the Unified Protocol for transdiagnostic treatment of

emotional disorders in group format in Spain: Results from a
randomized controlled trial with 6-months follow-up

J. OSMA 1,2, O. PERIS-BAQUERO 1,2

, C. SUSO-RIBERA3, T. J. FARCHIONE4, &
D. H. BARLOW4
1
Universidad de Zaragoza, Zaragoza, Spain; 2Instituto de Investigación Sanitaria de Aragón, Zaragoza, Spain; 3Universitat
Jaume I, Castellón, Spain & 4Center for Anxiety and Related Disorders, Boston University (EEUU), Boston, MA, USA
(Received 23 February 2021; revised 24 May 2021; accepted 28 May 2021)

Abstract
Background The present study aims to investigate the effectiveness of the Unified Protocol (UP), a transdiagnostic
treatment of emotional disorders (EDs), when applied in a group format in the public mental health system in Spain.
Methods 488 participants with a primary diagnosis of ED were randomized to the UP group or to the treatment as usual
(TAU; individual, disorder-specific cognitive behavioral therapy). Personality, depression and anxiety symptoms, affect,
and quality of life were assessed at pre-treatment, 3 months after treatment onset (coinciding with the end of the UP
treatment), and 6 and 9 months after treatment onset (follow-ups). The moderating effect of the treatment condition and
the number of sessions received in the evolution of study outcomes was investigated with a linear mixed model analysis.
Results A significant improvement in outcomes occurred in both conditions, except for extraversion in the TAU.
Improvements in depression, anxiety and quality of life were larger in the UP condition. After the treatment,
improvements were maintained at follow-ups in all study outcomes. An interaction between Time∗ Condition∗ Sessions
was found for depression.
Conclusion The results add to the existing evidence on the effectiveness of the UP and may be important for implementation
purposes in the Spanish or other similar public mental health systems. Trial registration number NCT03064477 (March 10,
2017).

Keywords: emotional disorders; Unified Protocol; transdiagnostic; group format; public mental health

Clinical or Methodological Significance of this Article: This is a randomized multicenter clinical trial applied in a
naturalistic environment. A significant improvement in outcomes occurred both in the UP and TAU conditions. Changes
in depression, anxiety and quality of life were larger in the UP condition and the improvements were obtained in less
time and were maintained at 6 and 9 months after treatment onset (follow-ups). The UP, a transdiagnostic treatment for
emotional disorders, applied in group format might be an efficient treatment option for public health settings in Spain.

Introduction
The Unified Protocol for the transdiagnostic treat-
ment of emotional disorders (UP) is a cognitive–be-
havioral intervention developed to address
emotional disorders (EDs; anxiety, depression and
related disorders; Barlow et al., 2011a). People
with EDs experience: (a) frequent and intense
negative emotions (e.g., anxiety, anger, sadness or
guilt); (b) aversive reactions to these emotions, and
(c) urges to avoid these emotional experiences, gen-
erally using maladaptive strategies (Bullis et al.,
2019). There is also considerable evidence that
these shared characteristics by individuals presenting
EDs may be explained by underlying temperamental

Correspondence concerning this article should be addressed to Jorge Osma Departamento de Psicología y Sociología, Facultad de Ciencias
Sociales y Humanas, Universidad de Zaragoza, C/Ciudad Escolar s/n, 44003, Teruel, Spain. Email: osma@unizar.es

© 2021 Society for Psychotherapy Research

2 J. Osma et al.
characteristics, particularly high neuroticism, thus
resulting in emotion dysregulation (Barlow et al.,
2014).
The efficacy of the UP for EDs has been supported
by numerous randomized control trials, as evidenced
in recent systematic reviews (Cassiello-Robbins
et al., 2020; Sakiris & Berle, 2019). However, the
majority of studies to date have been conducted in
highly controlled research settings (e.g., laboratories,
private centers or residential treatment centers;
Boswell et al., 2012; Thompson-Brenner et al.,
2019) and in an individual format. This is important
to mention because individuals with EDs often seek
help at public health institutions and these organiz-
ations are still in need of cost-effective and affordable
interventions for common mental health problems
(Saxena et al., 2007).
The UP might provide a feasible solution to the
aforementioned problems associated with the
limited resources for mental health treatments in
public settings. For example, the UP has been
adapted to be administered in a group format, with
is important for cost-effectiveness purposes (Laposa
et al., 2017). Additionally, the fact that the UP can
be applied to individuals within the full range of
EDs facilitates the creation of such groups.
To our knowledge, nine studies have now provided
evidence on the effectiveness of group UP for EDs
(Cassiello-Robbins et al., 2020). Of these, four
were non-controlled studies (Grill et al., 2017;
Laposa et al., 2017; Osma et al., 2015; Varkovitzky
et al., 2018), two were randomized controlled trials
(de Ornelas Maia et al., 2017; Zemestani et al.,
2017), one was a non-randomized controlled trial
(de Ornelas Maia et al., 2015), and two were open
trials (Bullis et al., 2015; Reinholt et al., 2017).
Finally, only four of these nine studies were con-
ducted in public mental health settings (de Ornelas
Maia et al., 2015; Osma et al., 2015; Reinholt
et al., 2017; Varkovitzky et al., 2018).
The results of the previous investigations on the
effectiveness of a group UP intervention are promis-
ing and moderate-to-large effects on anxiety (0.45 ≤
d ≤ 2.25) and depression symptoms (0.44 ≤ d ≤ 3.08)
have been reported. However, a number of limit-
ations have been also identified. For instance,
sample sizes have been generally small (11 ≤ n ≤
52), which limits the generalizability of these findings
and raises questions regarding the reliability of study
findings, including effect sizes, due to limited power.
In fact, as indicated above, effect sizes have been very
diverse across studies, ranging from moderate to very
large. Additionally, follow-up periods have been
either very short (up to 4 months) or non-existent
(in 5 out of 9 studies). Only one investigation
evaluated the effectiveness of the UP in a longer
term (12 month), but again the sample size was
small (n = 6; Osma et al., 2015).
A final shortcoming refers to the selection of out-
comes, which has been characterized by an excessive
focus on anxiety and depression symptomatology.
For example, only four in nine studies assessed
quality of life or personality and affect when explor-
ing the effectiveness of the UP in group format.
This is important because the UP aims to lead to
enduring changes in personality (i.e., neuroticism)
and functioning (i.e., quality of life) (Barlow et al.,
2014). So far, the UP applied in a group format
appears to result in moderate-to-large changes in
quality of life (Bullis et al., 2015; de Ornelas Maia
et al., 2017; Osma et al., 2015; Reinholt et al.,
2017), positive and negative affect (Laposa et al.,
2017; Osma et al., 2015; Reinholt et al., 2017),
and neuroticism (Osma et al., 2015).
As noted earlier, the existing findings in relation to
group UP interventions are promising. However,
higher quality investigations using large samples,
long follow-up periods, and ecological settings
(e.g., public mental health settings) are still needed
to support the effectiveness and durability of the
UP delivered in a group format. The aim of the
present study is to investigate the effectiveness of
the UP applied in group format in public mental
health settings in Spain. Building upon prior research
and the described limitations in the literature, this
multicenter randomized controlled trial will include
a wide range of outcomes (anxiety and depression
symptoms, quality of life, positive and negative
affect, neuroticism, and extraversion) and will inves-
tigate the durability of changes up to 6 months after
the end of the UP intervention (9 months after treat-
ment onset) in a large sample of individuals with a
wide range of EDs.
Consistent with previous research, we hypothesize
that the UP will produce significant moderate-to-
large improvements on all outcomes. Also similar to
past research (Cassiello-Robbins et al., 2020; Sakiris
& Berle, 2019), we expect that a moderation analysis
will reveal that both interventions exert comparable
effects on outcomes (moderation by treatment con-
dition is not significant) on study outcomes when
comparing the UP with the active comparator, that
is, non-protocolized individual cognitive–behavioral
therapy (CBT)—the usual treatment in public
health settings in Spain. Because patients in both con-
ditions are likely to receive a dissimilar number of
treatment sessions due to the limited resources avail-
able for frequent (i.e., weekly) individual therapy, we
will also analyze the moderating role of the number
of sessions in an exploratory manner.
 Psychotherapy Research 3

Method (supplementary material). In the UP group, the

Participants
The public mental health centers collaborating in the
study are described in (Osma et al., 2018). The
sample was recruited from 10 public mental health
centers and was composed of 488 participants. Par-
ticipants were randomly allocated to the UP (n =
279) or the TAU (n = 209). The distribution of par-
ticipants according to the treatment condition and
the center was: Center 1: TAU (n = 18), UP (n =
26, grouped in 2 groups); Center 2: TAU (n = 47),
UP (n = 82, grouped in 6 groups); Center 3: TAU
(n = 16), UP (n = 22, grouped in 2 groups); Center
4: TAU (n = 39), UP (n = 37, grouped in 4
groups); Center 5: TAU (n = 16), UP (n = 12,
grouped in 2 groups); Center 6: TAU (n = 17), UP
(n = 18, grouped in 2 groups); Center 7: TAU (n =
13), UP (n = 16, grouped in 2 groups); Center 8:
TAU (n = 20), UP (n = 21, grouped in 2 groups);
Center 9: TAU (n = 10), UP (n = 26, grouped in 2
groups); Center 10: TAU (n = 13), UP (n = 19,
grouped in 2 groups). Figure 1 shows the
CONSORT flow diagram. The sample size was suf-
ficient according to previous calculations published
in the protocol of the current study (Osma et al.,
2018).
The sociodemographic information is reported in
Table I. Principal and comorbid ED diagnosis of
the participants can be found in Appendix 1
mean age of the participants was 42.76 years (SD =
11.61) and 79.2% of them were women (n = 221).
In the TAU condition, their main age was 42.45
years (SD = 13.01) and 78.0% of participants were
women (n = 163). In total, 220 participants in the
UP (78.9%) and 154 participants in the TAU con-
dition (73.7%) were taking psychotropic medication
at the time of enrollment and randomization.
Measures
Diagnosis. The Spanish version of the Anxiety Dis-
orders Interview Schedule for DSM-IV-Lifetime
Version (ADIS-IV-L; Di Nardo et al., 1994) trans-
lated by Botella and Ballester (1997) was used for
diagnostic purposes. Test-retest reliability varies
depending on the study from .68 to 1.00 (Brown
et al., 2001). The ADIS-IV-L, as opposed to the
ADIS-5, was used because the new clinical interview
for DSM-5 was not available in Spanish at the time
the initial recruitment took place.
Personality. The NEO Five-Factor Inventory
(NEO-FFI; Costa & McCrae, 1999) is a self-report
inventory which offers a rapid measure of the Big
Five personality structure, namely neuroticism,
extraversion, openness to experience, agreeableness,
and conscientiousness. This questionnaire consists
of 60 items. In the NEO-FFI, individuals are asked

Table I. Socio-demographic characteristics of the participants (N = 488).

UP (n = 279) TAU (n = 209) Total (N = 488)

n (%) n (%) n (%)

Educational level
Less than 12 years of education 105 (37.6) 81 (38.7) 186 (38.1)
Secondary studies 60 (21.5) 38 (18.2) 98 (20.1)
Primary studies or less 45 (16.1) 43 (20.6) 88 (18.00)
More than 12 years of education 174 (62.4) 128 (61.3) 302 (61.9)
Vocational training 75 (26.9) 56 (26.8) 131 (26.8)
University studies 72 (25.8) 46 (22.0) 118 (24.2)
High school 27 (9.7) 26 (12.4) 53 (19.9)
Marital status
Married/living with partner 153 (54.8) 102 (48.8) 255 (52.3)
Not Married/not living with partner 126 (45.2) 107 (51.2) 233 (47.7)
Single 75 (26.9) 76 (36.4) 151 (30.9)
Separated/ Divorced 45 (16.1) 27 (12.9) 72 (14.8)
Widowed 6 (2.2) 4 (1.9) 10 (2.0)
Job status
Working 126 (45.2) 99 (47.4) 225 (46.1)
Not working 153 (54.8) 110 (52.6) 263 (53.9)
Unemployed 53 (19.0) 43 (20.6) 96 (19.7)
Sick leave 53 (19.9) 37 (17.7) 90 (18.4)
Home-maker 19 (6.8) 9 (4.3) 28 (5.7)
Student 17 (6.1) 14 (6.7) 31 (6.4)
Retired 11 (3.9) 7 (3.3) 18 (3.7)

Note: UP: Unified Protocol; TAU: Treatment as usual.

4 J. Osma et al.
Figure 1. CONSORT diagram illustrating participant flow in the study.
to respond using a 5-point Likert scale ranging from
0 (totally disagree) to 4 (totally agree). We only
present data on neuroticism and extraversion
because these are the underlying temperamental
characteristics proposed in the transdiagnostic
model of EDs (Brown & Barlow, 2009). The internal
consistency in the present sample was α = .77 for
neuroticism and α = .82 for extraversion.
Affect. The Positive and Negative Affect Schedule
(PANAS; Sandín et al., 1999; Watson et al., 1988)
consists of 20 items that evaluate positive and
negative affect, with 10 items for each dimension.
Responses use a 5-point Likert scale ranging from 1
(very slightly or not at all) to 5 (extremely). The
internal consistency in the present sample was good
for both scales, that is, α = .90 for positive affect
(PA) and α = .90 for negative affect (NA).
Depression. Depression was evaluated with the
Beck Depression Inventory-II and the Overall
Depression Severity and Impairment Scale. The
Beck Depression Inventory-II (BDI-II; Beck et al.,
1996), validated into Spanish by Sanz et al. (2003),

is a 21-item self-report questionnaire that measures
the severity of depressive symptoms. The scale has
a 0–63 range and responses are rated from 0
“absence of depressive symptoms” to 3 “severe
levels of depression”. The internal consistency of
the BDI-II in the present sample was excellent (α
= .92). The Overall Depression Severity and Impair-
ment Scale (ODSIS; Bentley et al., 2014), validated
in Spanish by Osma et al. (2019), is a 5-item measure
that evaluates the frequency and intensity of depress-
ive symptoms and their interference with the person’s
work or school life and social life. The total score
ranges from 0 to 20 and responses use a 5-point
Likert scale ranging from 0 (None) to 4 (All the
time). The internal consistency of the ODSIS in
the present sample was α = .92.
Anxiety. Anxiety was measured with the Beck
Anxiety Inventory and the Overall Anxiety Severity
and Impairment Scale. The Beck Anxiety Inventory
(BAI; Beck & Steer, 1993), validated into Spanish
by Sanz et al. (2012), is a 21-item measure of
anxiety symptoms. The total score in the BAI
ranges from 0 to 63 and responses use a 4-point
Likert scale ranging from 0 (Not at all) to 3
(Severely). The internal consistency of the BAI in
the present sample was α = .92. The Overall
Anxiety Severity and Impairment Scale (OASIS;
Norman et al., 2006), validated in Spanish by
Osma et al. (2019), is a 5-item measure that evalu-
ates the frequency and intensity of anxiety symptoms
and their interference with the person’s work or
school life and social life. All items are rated on a 5-
point Likert scale ranging from 0 (None) to 4 (All
the time). The total scale score ranges from 0 to
20. In the present sample, the Cronbach’s alpha
was α = .92.
Quality of life. The Quality of Life Index (QLI;
Mezzich et al., 2000) consists of 10 items that evalu-
ate different dimensions of quality of life. The total
score ranges from 10 to 100 and each item is evalu-
ated on a 10-point numerical rating scale ranging
from 1 (Bad) to 10 (Excellent). The Cronbach’s
alpha in the present sample was α = .86.
Procedure
The ethical and research committees of all collabor-
ating centers approved this ongoing multicenter ran-
domized controlled trial NCT03064477 (March 10,
2017). Participants were stratified according to the
severity of anxiety and depression symptomatology
(evaluated with the BDI-II and the BAI). Next,
using a computer-generated sequence (Randomizer),
participants were randomized to the UP or the TAU
condition. Each center had their own randomization
Psychotherapy Research 5
list, which was provided by an external researcher not
belonging with the center.
Inclusion criteria to participate in the study were:
(a) having a principal (most interfering and severe)
ED disorder diagnosis (i.e., anxiety disorder, mood
disorder, adjustment disorder, among others); (b)
being aged 18 or over; (c) being fluent in the
language in which therapy is performed (Spanish or
Catalan in the present study); (d) being able to
attend to the evaluation and treatment sessions and
signing the informed consent form; (e) patients
taking pharmacological treatment were asked to
maintain the same dosages and medications for at
least 3 months prior to enrolling into the study and
during the whole treatment. Exclusion criteria
were: (a) presence of a severe condition that would
require to be prioritized for treatment, so that an
interaction between both interventions could not be
ruled out. These include a severe mental disorder
(bipolar disorder, schizophrenia, or an organic
mental disorder), suicide risk at the time of assess-
ment, or substance use in the last three months; (b)
the patient has previously received 8 or more sessions
of psychological treatment with clear and identifiable
Cognitive Behavioral Therapy (CBT) principles
within the past 5 years.
Regarding therapist expertise, all therapists were
licensed psychologists with between 8 and 20 years
of experience (n = 8, 44.4%) or clinical psychology
residents with 2–4 years of experience (n = 10,
55.6%) in delivering CBT in an individual format
(TAU). In addition, all therapists and co-therapists
in the UP groups received a UP training workshop
before starting the intervention. This consisted of 2
or 3 group workshop sessions where therapists were
instructed on the delivery of the different treatment
modules of the UP. The duration of the course was
between 10 and 20 h, depending on the availability
of the center’s therapists. In addition to the work-
shop, all therapists received an individual training
during 12 therapy sessions. The individual training
consisted of an online supervision before each
session or the participation as a co-therapist with an
expert delivering the UP intervention, who also
assesses treatment fidelity. In both cases, the training
was conducted by the leading author (J.O.), who has
been certified as a UP Trainer by the Unified Proto-
col Institute.
The 8 treatment modules of the UP were adminis-
tered during 12 two-hour group treatment sessions,
at a rate of one session per week. The treatment
modules included: (1) Setting goals and maintaining
motivation; (2) Understanding the adaptability of
emotions; (3) Mindful emotion awareness; (4) Cog-
nitive flexibility; (5) Countering emotional beha-
viors; (6) Understanding and confronting physical
6 J. Osma et al.

sensations; (7) Exposure to emotions; (8) Recogniz- Data Analysis

ing accomplishments and looking to the future (for
Analyses were carried out using SPSS version 22.0
more information see Osma et al., 2018). The UP
(IBM Corp, 2013). First, the sociodemographic
treatment was conducted over approximately three
characteristics of the sample were analyzed (n = 488).
months. If clinicians considered that there was a
Next, comparisons of patients who received the TAU
need to provide additional sessions to the partici-
and the UP condition were investigated using a multi-
pants after treatment completion due their clinical
variate analysis of variance (MANOVA) for continu-
status, they were allowed to do so in an individual
ous variables and a chi-square test for categorical
format (each session would have an approximate
variables. The same procedure will be used to
duration of 35 min). This information was collected
compare the characteristics between the participants
and will be described later in the corresponding
in the UP condition who required extra treatment ses-
section. Groups were composed of eight to ten par-
sions and those who did not.
ticipants and two clinicians (therapist and co-thera-
Following this, a linear mixed model analysis with
pist). All participants in the UP condition received
compound symmetry as a covariance structure (AL-
the UP workbook (Barlow et al., 2011b).
Marshadi, 2014) was performed. Main effects of
The TAU at the collaborating public mental health
time were used to assess if there were improvements
centers is individual, non- protocolized CBT plus
in outcomes throughout the study. In addition to the
pharmacological treatment (i.e., antidepressants
main effect of time, we also included the main effects
and/or anxiolytics). In the TAU condition, partici-
of treatment condition and number of sessions. This
pants received the number of sessions established
was done to calculate interaction effects (treatment
by their therapists according to their clinical judg-
condition∗ time, as well as treatment condi-
ment and the availability of therapists based on
tion∗ number of sessions∗ time) that would reveal
waiting lists in the collaborating settings. The dur-
whether the treatment condition and the number of
ation of sessions was, on average, 35 min each (SD
sessions received interacted with time in the predic-
= 5.05, ranging from 30 to 40 min depending on
tion of changes in study outcomes (i.e., whether
the center). The most commonly used techniques
changes in outcomes were different across treatment
in this treatment condition included: psychoeduca-
conditions and dependent on the number of treat-
tion, cognitive restructuring, exposure techniques,
ment sessions received).
and activity scheduling (used by 90% of the thera-
Next, we conducted a post hoc analysis when a sig-
pists), followed by mindfulness techniques (80%),
nificant interaction was observed in the mixed model
relaxation techniques (70%), problem-solving train-
analyses. To do so, we categorized the number of ses-
ing (70%), and communication skills training (50%).
sions using a half standard deviation below and above
Participants from both conditions were patients
our sample mean (i.e., ≤8 sessions, 9–12 sessions,
who attended mental health units for psychological
and > 12 sessions). Similar to past research (Kerig
treatment and were not compensated economically
et al., 2011), by doing this we expected to distinguish
for their participation. Irrespective of the assigned
subgroups of patients who presented a different evol-
condition, participants completed four evaluations
ution in study variables according to the number of
at the same times, that is, at pre-treatment, at 3
sessions they received.
months after treatment onset (coinciding with the
As a final step, as recommended by the literature in
end of the UP treatment), and 6 and 9 months
multicenter studies (Leichsenring et al., 2013),
after treatment onset (follow-ups). Assessments
center effects were included as a random effect in
were conducted by trained evaluators who were
the linear mixed model. Specifically, we included as
blind to the number of sessions performed and the
Center∗ Time interaction in order to assess the mag-
clinical status of the participants in the TAU con-
nitude of the random variance(s) at the between
dition (e.g., clinical discharge or still in treatment).
and within-center levels.
This means that, at the end of the month 9 after treat-
ment onset, patients in the TAU condition received 9
months of episodical (i.e., often monthly, as will be
described later) individual CBT, while patients in Results
the UP condition received an intensive 3-month
Treatment Sessions Received Over Time in
UP treatment in group format. Participants in both
UP and TAU Conditions
conditions were allowed to use pharmacological
treatment in addition to psychological intervention. The average number of treatment sessions 9 months
However, they were asked to maintain the same after treatment onset was 12.49 (SD = 2.18, range =
dosages from three months prior to the onset of the 8–18) in the UP group and 6.07 (SD = 2.51, range =
intervention and until the end of the study. 3–14) in the TAU condition. After the end of the UP

treatment, 18 (7.14%) participants in the UP con-
dition were provided with additional individual UP ses-
sions (mean = 2.22 sessions, SD = 1.51, range = 1–5).
Sociodemographic Characteristics of the
Sample and Differences Between Treatment
Conditions Before Treatment Onset
(Baseline Assessment)
The MANOVA indicated no significant baseline
differences in any of the study variables, including
age, the BDI, the BAI, and remaining study out-
comes when comparing the TAU and the UP (p
> .05). No baseline differences were found in
gender (χ 2 (1) = .106, p = .744) and clinical diag-
noses (χ 2 (2) = 1.174, p = .556) between conditions
either. Similarly, no differences were found
between the participants who required extra UP
treatment sessions and those who did not in any of
the study outcomes (p > .05) and sociodemographic
variables, including age (F(1) = .018, p = .895),
gender (χ 2 (1) = 2.498, p = .114), and clinical diag-
nosis (χ 2 (14) = 10.779, p = .703).
Changes in Personality, Affect, Depression,
Anxiety, and Quality of Life After the
Interventions
As seen in Table II, there was a significant effect of
time after the UP application. We found moderate-
to-large effect sizes of the UP on neuroticism (F =
48.41, p < .001, dof = 488.361, pretreatment to 9
months after treatment onset Cohen’s d = 0.72),
negative affect (F = 27.66, p < .001, dof = 532.93,
pretreatment to 9 months after treatment onset
Cohen’s d = 0.76), the BDI-II (F = 109.29, p
< .001, dof = 482.15, pretreatment to 9 months
after treatment onset Cohen’s d = 0.87), the ODSIS
(F = 70.74, p < .001, dof = 490.04, pretreatment to
9 months after treatment onset Cohen’s d = 0.78),
the BAI (F = 60.30, p < .001, dof = 487.30, pretreat-
ment to 9 months after treatment onset Cohen’s d =
0.69), the OASIS (F = 78.49, p < .001, dof = 499.65,
pretreatment to 9 months after treatment onset
Cohen’s d = 0.90), and the QLI (F = 63.53, p
< .001, dof = 491.07, pretreatment to 9 months
after treatment onset Cohen’s d = −0.83). The
results also revealed significant moderate effects of
the UP on extraversion (F = 19.41, p < .001, dof =
470.81, pretreatment to 9 months after treatment
onset Cohen’s d = −0.41) and positive affect (F =
25.59, p < .001, dof = 504.20, pretreatment to 9
months after treatment onset Cohen’s d = −0.57).
Regarding the TAU condition, a significant effect of
time was also observed. Effect sizes were moderate on
Psychotherapy Research 7
neuroticism (F = 14.17, p < .001, dof = 392.42, pre-
treatment to 9 months after treatment onset Cohen’s
d = 0.45), negative affect (F = 20.22, p < .001, dof =
427.81, pretreatment to 9 months after treatment
onset Cohen’s d = 0.61), positive affect (F = 5.70, p
= .001, dof = 393.69, pretreatment to 9 months after
treatment onset Cohen’s d = −0.27), the BDI-II (F
= 48.73, p < .001, dof = 386.22, pretreatment to 9
months after treatment onset Cohen’s d = 0.70), the
ODSIS (F = 12.09, p < .001, dof = 384.74, pretreat-
ment to 9 months after treatment onset Cohen’s d =
0.41), the BAI (F = 25.31, p < .001, dof = 392.16, pre-
treatment to 9 months after treatment onset Cohen’s d
= 0.49), the OASIS (F = 12.31, p < .001, dof =
392.09, pretreatment to 9 months after treatment
onset Cohen’s d = 0.49) and the QLI (F = 18.46, p
< .001, dof = 394.56, pretreatment to 9 months after
treatment onset Cohen’s d = −0.47). No significant
changes were observed on extraversion after the
TAU intervention (F = .43, p = .733, dof = 391.01,
pretreatment to 9 months after treatment onset
Cohen’s d = −0.12).
As indicated in Table II, relevant improvements
mostly emerged when comparing the pre-treatment
and 3 months after treatment onset (coinciding
with end of the UP treatment), especially in the
case of the UP condition (all effect sizes over 0.30).
The improvements accomplished after 3 months of
treatment were generally maintained after treatment
termination (during the follow-ups, which occurred
3 and 6 months after the UP treatment finished).
This was evidenced by the small effect sizes pre-
sented in Table II when comparing the 3 months
after treatment onset (end of UP treatment) with
the 6-month after treatment onset (3 months after
UP termination). In this case, the Cohen’s d’s were
generally close to 0 or smaller than 0.30, except for
negative affect in the TAU condition, which obtained
a Cohen’s d of 0.35 (continued to improve). Similar
findings were obtained when comparing the results 6
and 9 months after treatment onset, where Cohen’s d
was generally close to 0 or smaller than 0.30.
Main Effects and Interaction Effects of
Treatment Condition and Number of
Sessions
The results of the main effects and interaction effects
of the treatment condition and the number of ses-
sions can be found in Table III. A main effect of
treatment condition was found on the BDI-II (F =
9.01, p = .003, dof = 972.16, Cohen’s d = 0.27), the
ODSIS (F = 8.10, p = .005, dof = 994.24, Cohen’s
d = 0.26), the BAI (F = 9.52, p = .002, dof =
986.50, Cohen’s d = 0.28), the OASIS (F = 9.92, p
 8
J. Osma et al.

Table II. Main effects of the linear mixed models across different treatment periods (N = 488).

Main effects
Cohen’s d
Dependent variable Time 1 Time 2 Time 3 Time 4 F p
M (SD) M (SD) M (SD) M (SD) Time 1-to-Time 2 Time 2-to-Time 3 Time 3-to-Time 4 Time 1-to-Time 4

Neuroticism UP 32.36 (7.55) 29.17 (8.20) 27.63 (8.80) 26.31 (9.20) 48.41 < .001 0.40 0.18 0.15 0.72
TAU 31.88 (7.63) 29.82 (8.07) 28.92 (7.54) 28.44 (7.77) 14.17 < .001 0.26 0.11 0.06 0.45
Negative Affect UP 28.56 (8.48) 23.31 (8.21) 24.32 (7.96) 21.99 (8.71) 27.66 < .001 0.63 −0.12 0.28 0.76
TAU 28.92 (8.23) 25.73 (9.19) 22.66 (7.69) 23.91 (8.27) 20.22 < .001 0.36 0.35 −0.16 0.61
Extraversion UP 21.58 (8.45) 23.73 (8.63) 24.34 (8.65) 25.21 (9.17) 19.41 < .001 −0.25 −0.07 −0.10 −0.41
TAU 22.36 (8.47) 22.31 (8.83) 22.34 (8.68) 23.40 (8.50) 0.43 .733 0.11 −0.00 −0.12 −0.12
Positive Affect UP 20.57 (6.86) 23.97 (8.03) 24.32 (7.96) 25.16 (9.09) 25.59 < .001 −0.45 −0.04 −0.10 −0.57
TAU 20.91 (6.98) 22.79 (7.13) 22.66 (7.69) 22.93 (7.96) 5.70 .001 −0.27 0.02 −0.03 −0.27
BDI-II UP 27.87 (12.34) 17.92 (13.11) 16.69 (13.41) 16.31 (14.01) 109.29 < .001 0.78 0.09 0.03 0.87
TAU 27.97 (12.25) 21.63 (12.64) 20.62 (13.82) 18.70 (14.29) 48.73 < .001 0.51 0.08 0.14 0.70
ODSIS UP 10.10 (5.09) 6.08 (5.47) 5.63 (5.51) 5.67 (6.17) 70.74 < .001 0.76 0.08 −0.01 0.78
TAU 9.35 (5.43) 7.86 (6.00) 7.32 (5.76) 7.12 (5.44) 12.09 < .001 0.26 0.09 0.03 0.41
BAI UP 26.75 (13.06) 18.57 (13.31) 17.44 (14.14) 17.04 (14.86) 60.30 < .001 0.62 0.08 0.03 0.69
TAU 26.72 (13.48) 22.27 (14.12) 21.21 (14.25) 19.89 (14.08) 25.31 < .001 0.32 0.07 0.09 0.49
OASIS UP 10.83 (4.37) 6.95 (4.81) 6.31 (5.02) 6.33 (5.54) 78.49 < .001 0.84 0.13 −0.00 0.90
TAU 10.53 (4.62) 8.65 (5.11) 8.67 (6.06) 8.16 (5.07) 12.31 < .001 0.38 −0.00 0.09 0.49
QLI UP 4.52 (1.64) 5.57 (1.83) 5.72 (1.79) 6.00 (1.92) 63.53 < .001 −0.60 −0.08 −0.15 −0.83
TAU 4.60 (1.58) 5.16 (1.69) 5.47 (1.88) 5.43 (1.90) 18.46 < .001 −0.34 −0.17 0.02 −0.47

Note: Time 1: Pre-Treatment; Time 2: 3-month after treatment onset (coinciding with end of UP treatment); Time 3: 6-month after treatment onset; Time 4: 9-month after treatment onset; M:
Mean; SD: standard deviation; UP: Unified Protocol; TAU: Treatment as usual; BDI-II: Beck Depression Inventory; ODSIS: Overall Depression Severity and Impairment Scale; BAI: Beck
Anxiety Inventory; OASIS: Overall Anxiety Severity and Impairment Scale; QLI: Quality of Life Index; p < 0.05: statistically significant; Cohen’s d ≈ 0.2: Small effect sizes; Cohen’s d ≈ 0.5:
Medium effect sizes; Cohen’s d ≈ 0.8: Large effect sizes.
 Cohen’s

0.18
0.18
0.12
0.16

0.13

Note: BDI-II: Beck Depression Inventory; ODSIS: Overall Depression Severity and Impairment Scale; BAI: Beck Anxiety Inventory; OASIS: Overall Anxiety Severity and Impairment Scale; QLI:
d
= .002, dof = 1016.50, Cohen’s d = 0.29), and the

QLI

.012
.048
.203
.030

2.14 .059
QLI (F = 3.93, p = .048, dof = 1018.56, Cohen’s d

p
= 0.18). The post hoc analyses of the main effect of

3.68
3.93
1.62
3.01
F
treatment condition can be seen in detail in Appen-

Cohen’s
dix 2 (supplementary material). The main effect of

0.23
0.29
0.05
0.20

0.13
d
the number of sessions was not significant on any
OASIS outcome (p > .05).

.000
.002
.603
.004

1.94 .085
p
In terms of the interaction effects, a Time∗ condi-

6.16
9.92
0.27
4.56
tion effect was evidenced for the BDI-II (F = 4.67, p
F

= .003, dof = 695.11, Cohen’s d = 0.20), the ODSIS

Cohen’s

0.24
0.28
0.02
0.18

0.13
(F = 4.05, p = .007, dof = 719.88, Cohen’s d =
d

0.18), the BAI (F = 3.96, p = .008, dof = 713.99,

BAI

.000
.002
.852
.008

2.12 .061
Cohen’s d = 0.18), the OASIS (F = 4.56, p = .004,
p

dof = 740.59, Cohen’s d = 0.20) and the QLI (F =

7.01
9.52
0.03
3.96
F

3.01, p = .030, dof = 736.02, Cohen’s d = 0.16).

These findings together with an inspection of Table
Cohen’s

0.22
0.26
0.07
0.18

0.16

II evidenced that the UP resulted in larger improve-

d
ODSIS

ments in depression (BDI-II and ODSIS), anxiety

.001
.005
.474
.007

3.03 .010

(BAI and OASIS), and quality of life when compared

Quality of Life Index. p < 0.05: statistically significant; Cohen’s d small ≈ 0.2; Cohen’s d medium ≈ 0.5; Cohen’s d large ≈ 0.8.
p

with the TAU. In contrast to this, both interventions

5.53
8.10
0.51
4.05
F

produced comparable changes in neuroticism, nega-

Cohen’s

tive affect, extraversion, and positive affect.

0.29
0.27
0.18
0.20

0.15
d

Finally, the linear mixed model analyses showed an

interaction effect of Time∗ Condition∗ Sessions for the
BDI-II

.000
.003
.843
.003

2.82 .016
P

BDI-II (F = 2.82, p = .016, dof = 672.88, pretreat-

ment to 9 months after treatment onset Cohen’s d =
10.37
9.01
0.04
4.67
F

0.15) and the ODSIS (F = 3.03, p = .010, dof =

693.72, pretreatment to 9 months after treatment
Cohen’s

0.06
0.03
0.16
0.06

0.07
Positive Affect

onset Cohen’s d = 0.16). Post hoc analyses were

carried out considering the treatment condition and
.722
.361
.072
.763

0.55 .744

subgroups according to the number of sessions

P

received (less or equal to 8, from 9 to 12, and more

0.44
0.83
3.25
0.39
F

than 12 sessions). The results are reported in Table IV.

Cohen’s

In the UP condition, a statistically significant main

0.10
0.14
0.00
0.14

0.08
d
Extraversion

effect of time was found in the BDI-II in participants

who received 9–12 sessions (F = 27.77, p < .001) and
.331
.131
.962
.075

0.79 .554
p

more than 12 sessions (F = 19.59, p < .001). A statisti-

<0.01

cally significant main effect of time was also found in

1.14
2.28

2.31
F
Table III. Main effects of the linear mixed models (N = 488).

the ODSIS in subgroups who received 9–12 sessions

Cohen’s

(F = 21.26, p < .001) and more than 12 sessions (F =

0.11
0.00
0.12
0.11

0.08
Negative Affect

15.68, p < .001). The strongest effects of time were

observed in the subgroup of participants who received
.246
.985
.200
.208

0.68 .637
p

9–12 sessions (Cohen’s d over 0.96 in both cases).

In the TAU condition, only the subgroup of par-
<0.01
1.38

1.65
1.52
F

ticipants who received 8 sessions or less showed stat-

istically significant improvements in the BDI-II (F =
Cohen’s

0.18
0.12
0.02
0.09

0.09
Neuroticism

38.14, p < .001, Cohen’s d = 0.72) and the ODSIS

d

(F = 10.45, p < .001, Cohen’s d = 0.52).

.010
.190
.849
.449

0.89 .484
p

3.83
1.72
0.04
0.88
F

Random Effects of Center on Study

Time∗ Condition

Outcomes
Condition

Sessions
Condition

The random effects were statistically non-significant

Sessions
Time∗
Time

for neuroticism (Wald Z = 1.00, p = .317, 95% confi-

∗

dence interval: 0.07–3.44), negative affect (Wald Z =

10 J. Osma et al.

1.88, p = .059, 95% confidence interval: 0.77–6.16),

variables for which there was a significant Time∗ Condition∗ Sessions effect (Table III) are included here. For the UP condition, the “less to 8 sessions” category was not included due to the reduced
number of participants in this group. The same occurred for the TAU condition in the 12-session group. p < 0.05: statistically significant; Cohen’s d small ≈ 0.2; Cohen’s d medium ≈ 0.5; Cohen’s
Time 1-to-Time 2 Time 2-to-Time 3 Time 3-to-Time 4 Time 1-to-Time 4

Note: Time 1: Pre-Treatment; Time 2: 3-month after treatment onset (coinciding with end of UP treatment); Time 3: 6-month after treatment onset; Time 4: 9-month after treatment onset; M:
Mean; SD: standard deviation; UP: Unified Protocol; TAU: Treatment as usual; BDI-II: Beck Depression Inventory; ODSIS: Overall Depression Severity and Impairment Scale. Only the
positive affect (Wald Z = 1.13, p = .258, 95% confi-

1.03
0.60
0.72
0.45
0.96
0.52
0.55
0.29
dence interval: 0.11–3.50), the ODSIS (Wald Z =
1.89, p = .059, 95% confidence interval: 0.07–
3.44), and the BAI (Wald Z = 0.63, p = .527, 95%
confidence interval: 0.03–13.96). For extraversion,
the BDI, the OASIS and the QLI convergence
issues were found, even when interactions were
−0.10
−0.06
−0.03

−0.26
−0.12

−0.11
0.21

0.05
increased to 3000.
Cohen’s d

Discussion
−0.10

−0.01

−0.05
0.30

0.08

0.35

0.12
0.37
To the best of our knowledge, this is the first multi-
center randomized controlled trial study conducted
in public mental health settings in Spain to show
the effectiveness of the UP for the transdiagnostic
treatment of EDs in group format. In relation to
the effectiveness of the treatments, we hypothesized
0.88
0.82
0.71
0.28
0.94
0.78
0.34
0.04

that both the UP and the TAU would result in sig-

nificant moderate-to-large improvements in study
outcomes. The results obtained in this study have
<.001
<.001
<.001

<.001
<.001
<.001
.215

.584

confirmed this hypothesis, with the only exception

p

of extraversion in the case of TAU.

Regarding the results of the UP, we expected that
27.77
19.59
38.14

21.26
15.68
10.45
1.57

.66
F

the UP would produce significant improvements

with moderate-to-large effects sizes on study out-
17.81 (15.29)
20.19 (14.45)
21.08 (14.12)
26.19 (18.29)
6.50 (6.49)
7.28 (6.19)
7.49 (5.61)
8.20 (7.56)

comes. Consistent with the former idea and in line

M (SD)
Time 4

with past research (Grill et al., 2017; Osma et al.,

2015), we found a large positive impact of the UP
on all outcomes. Importantly, these changes were
16.32 (13.89)
19.27 (13.75)
20.68 (12.88)
29.75 (15.42)

maintained in the follow-up periods even though

Main effects

4.97 (5.15)
6.53 (5.88)
7.80 (5.54)
7.42 (5.84)
M (SD)
Time 3

the large majority of the participants in the UP con-

Table IV. Post hoc analyses for the Time∗ Condition∗ Sessions effects (N = 488).

dition (92.86%) had not received additional treat-

ment during the follow-ups (6 and 9 months after
treatment onset). Of particular interest for the
20.56 (13.88)
17.96 (12.73)
21.67 (12.76)
29.57 (13.68)
6.91 (5.95)
6.25 (5.27)
8.49 (6.12)
9.86 (7.20)

present study was the finding that improvements in

M (SD)
Time 2

depression (BDI-II and ODSIS), anxiety (BAI and

OASIS), and quality of life were larger in the UP con-
dition than in the TAU group. These results add to
the existing research supporting the potential clinical
31.93 (11.83)
28.03 (11.69)
30.31 (11.39)
33.11 (11.60)
11.63 (3.87)
10.17 (4.82)
10.42 (4.99)
10.15 (5.78)

utility of the UP in group format for the treatment of

M (SD)
Time 1

EDs in public mental health settings (Reinholt et al.,

2017).
In addition to depression and anxiety, another rel-
Sessions

evant study finding was that the UP produced large

9–12

9–12
9–12

9–12
> 12

> 12
≤8

≤8

reductions in neuroticism and negative affect,

which is again consistent with previous literature
TAU

TAU

(Ornelas et al., 2017; Osma et al., 2015). These find-

UP

UP

ings support the idea that the UP is a useful interven-

Dependent variable

tion to address emotional dysregulation (high

neuroticism), a mechanism believed to be shared by
d large ≈ 0.8.

all patients with EDs (Barlow et al., 2014). Also con-

sistent with past research (Grill et al., 2017; Laposa
ODSIS
BDI-II

et al., 2017; Osma et al., 2015; Reinholt et al.,

2017), the present study results revealed moderate

effects of the UP on positive affect. Different to a pre-
vious investigation with a much smaller sample (n =
6; Osma et al., 2015), however, we found a signifi-
cant moderate effect of the UP on extraversion.
While the discrepancies between findings might be
attributable to small sample size in the previous
investigation, there is previous evidence to support
the social benefits of the group format (Burlingame
et al., 2013), which might explain the positive
results obtained in extraversion after the UP group
intervention. Finally, a large effect of the UP was
observed on quality of life. This result is again con-
sistent with recent findings from a systematic
review and meta-analysis of UP studies, including
those applied in group format (Sakiris & Berle,
2019), and supports the utility of the UP delievered
in group for the improvement of wide range of
outcomes.
It is important to note that the usual psychological
treatment in public mental health settings in Spain
generally occurs with a 4-to-6 week frequency.
Therefore, therapy can last several months or even
years and distress due to delayed consecutive
appointments—and therefore delayed training of
psychological skills—cannot be ruled out. Contrary
to this, changes with the UP occurred rapidly after
an intensive 3-month intervention and were main-
tained even though patients were no longer being
treated. Therefore, the UP in a group format might
provide a more feasible, ethical and effective alterna-
tive as groups can be more easily formed thanks to
the inclusion of a wide range of ED diagnoses and
allow treating several individuals at the same time
with little additional resources (i.e., a co-therapist
and a larger room). Ultimately, the adoption of a
group format and the selection of the UP as the treat-
ment option mean that patients will receive more
treatment sessions in a reduced period of time com-
pared to other existing treatment options (individual
therapy or disorder-specific CBT group interven-
tions). Additionally, by implementing UP groups
more patients can be treated in less time. Again,
this may help alleviate some of the issues associated
with limited resources that make the implementation
of empirically-supported psychological treatments in
public mental health systems difficult.
In addition to the effects of the UP compared with
the TAU, the present investigation also explored
whether the number of sessions received was a deter-
minant factor moderating the effect that treatments
had on outcomes. In this regard, the results support
the idea that this variable is not necessarily a decisive
one for treatment effectiveness. An interesting
finding, however, was observed in relation to the
interaction between the number of sessions and the
treatment condition in the prediction of depression
Psychotherapy Research 11
(BDI-II and ODSIS). In the UP condition, receiving
9–12 sessions was associated with greater improve-
ments, while approximately 8 sessions were the
optimal in the TAU condition. At an equal number
of sessions (9–12 sessions), the UP condition
obtained the best results. While these results should
be taken with caution due to their novelty, we encou-
rage researchers to include the number of sessions
into their models when comparing the effectiveness
of the UP with other active controls because this
might shed light into the recommended number of
sessions to achieve the desired results in individuals
with EDs.
It is important to note that only a small percentage
of participants in the UP condition (7.1%) required
additional treatment after the 12-session interven-
tion. The effect of this additional number of sessions
was controlled by including this variable (main effect
and interaction effect) in the prediction of outcomes.
Most importantly, what this small prevalence of par-
ticipants requiring additional treatment means is that
the majority of participants with ED diagnosis found
sufficient help with the pre-established intervention.
This result is relevant for public health care managers
and authorities because it suggests that only a very
small proportion of participants will probably
require additional resources when the UP in group
format is implemented. In addition, the results of
this study are likely to be generalizable to mental
health systems that are in a situation of collapse or
lack of resources. Attending to World Health Organ-
ization (WHO) estimates, depression and anxiety
disorders have increased between 14.9% and
18.4% from 2005 to 2015 worldwide (WHO,
2017), so if this growing trend is maintained over
time, all mental health systems, at least to some
extent, will need to cope with this large demand for
psychological care by offering effective and efficient
treatments. The results of this study can help in
this direction.
The results of this study should be considered in
light of a number of limitations. First, the assess-
ments were too long. Specifically, it took approxi-
mately 3 h to complete the first evaluation and
approximately 45 min to fill the rest of the evalu-
ations, since the ADIS was not administered sys-
tematically by all clinicians at all assessment
times (it was only required during the pre-evalu-
ation to establish clinical diagnoses [inclusion cri-
teria]). This may have reduced some participant’s
willingness to complete study evaluations. In this
sense, the inclusion of a shorter diagnostic inter-
view, such as the MINI (Sheehan et al., 2015) as
opposed to the ADIS (Di Nardo et al., 1994)
should be considered in future research conducted
in public mental health settings. Similarly, several
12 J. Osma et al.
measures of depression and anxiety symptoms
were used here because of the relatively recent
nature of the ODSIS and the OASIS. However,
there is now enough evidence to support their
use as measures of depression and anxiety symp-
toms (and interference) and both are rec-
ommended in the assessment of change with the
UP because they were developed according to
this psychological perspective (Osma et al.,
2019). These changes would facilitate the work
of clinical psychologists in the public system
because they are much shorter (5 items each)
than other traditional measures of depression and
anxiety, such as the BDI-II or the BAI (21 items
each). Additionally, because this study took place
across several public mental health settings, the
results might not be generalizable to other con-
texts. The study took place in many centers (10)
and each center contributed with a very different
number of participants (from 28 to 129 partici-
pants). Additionally, some differences in the train-
ing of therapists existed. This could have resulted
in patients from one specific center to improve
more than those from another center. Fortunately,
the center analyses showed no significant cen-
ter∗ time effects, which means that comparable
improvements were achieved regardless of the
center. Another aspect to highlight is the difficulty
to describe the TAU intervention in a precise way
due to the heterogeneity and variety of techniques
used. As some authors suggest, it is necessary to
clarify and take this into account in order to gen-
eralize the results (Wampold et al., 2011).
However, the fact that this study was performed
in public health settings as opposed to tightly con-
trolled clinical research contexts is one of the
novelties and strengths of this investigation.
Lastly, while this study included a follow-up
evaluation 9 months after treatment onset (6
months after UP termination), even longer
follow-up periods (i.e., 12-months) would be
desirable to ensure that results are maintained
after treatment completion.
To sum up, the results from this study suggest that
an intensive (12-sessions over 3 months) UP group
intervention is an effective solution for the treatment
of EDs. These findings are especially important due
the alarmingly high prevalence of EDs in our
society and their associated direct and indirect costs
(Ruiz-Rodríguez et al., 2017). It is therefore necess-
ary to develop and apply new forms of psychological
evidence-based treatments, as well as to improve the
cost–benefit relationship of psychological interven-
tions, especially in public settings where resources
are limited. The UP could be one option in this
direction.
Data Availability Statement
The data that support the findings of this study are
available from the corresponding author, [Jorge
Osma], upon reasonable request.
Acknowledgements
We would like to thank all collaborating centers, all
healthcare professionals, and all volunteers and par-
ticipants that made this study possible.
Supplemental data
Supplemental data for this article can be accessed
here https://doi.org/10.1080/10503307.2021.193
9190.
ORCID
J. OSMA http://orcid.org/0000-0002-7293-318X
O. PERIS-BAQUERO http://orcid.org/0000-
0002-2437-1207
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