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Evidence-Based Practice Paper

Macy Horine, Mackenzie Turk, Brisa Brinton, and Michelle Van

College of Nursing, University of Arizona

NURS 379: Scholarly Inquiry in Evidence-Based Practice

Dr. Stephanie Kelly

April 18, 2021

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Introduction

Generalized anxiety disorder (GAD) is a mental disorder characterized by symptoms of

excessive and uncontrolled worrying, stress, nervousness, restlessness, etc. that are present on

most days for six months or more at the time of diagnosis using the DSM-5 criteria (Elsevier,

2021). Patients with GAD encounter impairments in their physical well-being, social

relationships, work, home, and family life (Elsevier, 2021). The preferred treatment for GAD is

cognitive behavioral therapy and pharmacological treatment, which typically consists of

antidepressant therapy (Elsevier, 2021). Mindfulness-based stress reduction (MBSR) therapy, an

eight-week program developed by Jon Kabat-Zinn at the University of Massachusetts Medical

Center, involves purposely paying attention to the present moment without judgment (UMass

Memorial Health, n.d.). It aims to help clients develop better coping techniques with stressful

situations and improve focus, resilience, and the capacity to recover from stressors more quickly

(UMass Memorial Health, n.d.). Currently, there is a lack of known integrative therapies and

programs used to treat generalized anxiety disorder (GAD). As nursing students studying

integrative health, it is our mission to explore the treatments available for GAD and the

effectiveness of these treatments. In the treatment of GAD, evidence proves mindfulness-based

stress reduction therapies improve biological, physical, and psychological symptoms related to

GAD.

Background and Purpose

In 1979, Jon Kabat-Zinn developed Mindfulness-Based Stress Reduction (MBSR) at the

University of Massachusetts Medical School (Hazlett, 2020). This program was created to help

patients cope with stress due to chronic pain and illness. The program is usually eight weeks

long, where MBSR instructors teach patients how to incorporate mindfulness meditation and
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yoga practices into daily life (Hazlett, 2020). Although mindfulness‐based group therapies

(MGTs) for depressive, anxiety or stress and adjustment disorders are promising, there is a

substantial lack of knowledge regarding the long‐term improvements after such therapies in these

common psychiatric disorders. Although randomized controlled trials have found that MBSR is

effective for symptom reduction in individuals with GAD, research typically delivered MBSR to

small diagnostically homogeneous patient groups as opposed to larger diagnostically

heterogeneous patient groups (Hazlett, 2020). The purpose of this paper is to examine and

discuss the effectiveness of mindfulness-based therapy programs, including MBSR, Stress

Management Education (SME), Mindfulness-Based Cognitive Therapy (MBCT), and

Mindfulness Group Therapy (MGT), in treating symptoms associated with GAD in distinct

samples and settings through previous evidence-based research conducted.

PICOT Question

Our interventional PICOT questions reads, in individuals diagnosed with generalized

anxiety disorder (GAD), what is the effect of mindfulness therapy on lowering anxiety compared

to no mindfulness therapy?

Research Database Search

The databases used to conduct our research were PubMed, CINAHL, and Elsevier. We

limited our search by only including the publication years 2016 to 2021. In order to successfully

find evidence-based articles related to our PICOT question, key terms employed were

mindfulness, Generalized anxiety disorder, meditation, and integrative therapy.

Critical Appraisal of the Articles

Article One
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Hoge et al. (2018) conducted a quantitative, randomized control trial (RCT) conducted to

determine the effect of MBSR in patients with GAD on the stress hormones cortisol and

adrenocorticotropic (ACTH), and inflammatory markers TNF-alpha and IL-6 compared to SME.

Individuals diagnosed with GAD were randomly assigned to the MBSR group or SME (control

group). The MBSR group was an 8-week group-based intervention that included daily home

practice in breath-awareness and gentle yoga. Seventy-two participants agreed to blood

collection. Blood collection sample size ranged from n=62 to n=68 (Hoge et al., 2018). Blood

collection sample size ranged from n=62 to n=68. Blood collection procedures were conducted

between 1300 and 1630 to control hormonal variation (Hoge et al., 2018). Blood was collected at

four time points prior to completing the TSST and six times after completing the TSST. Using

area-under-the-curve (AUC) calculations, it was determined that there was no significant change

in cortisol levels but there was a statistically significant difference in ACTH levels (p=0.007),

TNF-alpha levels (p=0.038), and IL-6 levels (p=0.036) between the two groups (Hoge et al.,

2018). Therefore, MBSR therapies are a strategy to implement in decreasing biological stress

reactivity in individuals with GAD (Hoge et al., 2018). Though the data collected was found

through a well-designed RCT and well-validated TSST, it has limitations: a) small sample size b)

no clear reason as to why there was no significant change in cortisol AUC, and c) the study did

not include any potential confounds (Hoge et al., 2018). This research article directly relates to

our EBP topic as it confirms that mindfulness meditation is an appropriate intervention in

individuals diagnosed with GAD.

Article Two

In the quantitative randomized controlled research study article, written by Sandquist et

al. (2018), determined whether mindfulness-based group therapies (MGT) helped a higher
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number of patients with GAD in primary healthcare compared to those who had individual

treatment as usual (TAU). The sample size contained 215 individuals seeking treatment for their

diagnosed GAD in 2012 at 16 primary healthcare centers in southern Sweden. Traditional

psychotherapies were performed for a period of 8 weeks for both groups. All patients in this

study compleased four psychometric self-rated scales before treatment then again eight weeks

twelve months later. These scales included, “For all four psychometric scales (MADRS‐S

[Montgomery‐Åsberg Depression Rating Scale‐S], HADS‐D, HADS‐A [Hospital Anxiety and

Depression Scale A and D] and PHQ‐9 [Patient Health Questionnaire‐9]) the scores at the 1‐year

follow‐up were significantly improved in both groups” (Sandquist et al., 2018). This data was

compiled into generalized linear-mixed models, adjusted for cluster effects, allowing for all data

to be used, including those who dropped out of the study. One drawback was that immigrants

who could not speak Swedish fluently were not included in the RCT and conducting a reliable

study to include the vast populations of immigrants would not have been feasible (Sandquist et

al., 2018). The final results showcased that there were not significant differences in psychometric

scores between the MGT and TAU at the 1-year follow-up. The research article confirms that

psychotherapies work to improve symptoms of GAD equally in MGT or TAU. 

Article Three

Hazlett-Stevens (2020) conducted a quantitative, randomized control trial (RCT) to

examine what proportion of patients already enrolled in a general hospital MBSR program

presented with symptoms of GAD and whether such symptoms reduced after delivering MBSR

in large diagnostically heterogeneous groups. Twenty- six of 65 outpatients from a large general

hospital in the Silicon Valley of northern California enrolled in the MBSR program and indicated

moderate to severe GAD symptom severity at the first MBSR session. Of these 26 participants,
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19 voluntarily completed brief self-report measures at the beginning and end of their MBSR

course. Preliminary analyses were conducted with data to establish MBSR effectiveness. For

each measure, two-tailed paired samples t-test and Cohen’s d effect sizes were calculated to

compare pre-intervention scores from the first MBSR session to post-intervention scores from

the final MBSR session. Statistically significant reductions pre to post-MBSR were found on the

GAD-7, Penn State Worry Questionnaire, and Anxiety and Stress scales. Therefore, MBSR

delivered in hospital settings may provide an acceptable and effective treatment option for GAD

patients seeking care in hospital settings (Hazlett-Stevens, 2020). Although the naturalistic

design of the study maximizes external validity, several limitations should be considered.

Limitations of the study included: a) a design that relied on self-report screening measures, b) a

lack of inclusion and exclusion criteria as some participants reported concurrent medication

and/or therapy, and c) a lack of post-intervention data from 22 of the 65 participants. This

research study directly relates to our EBP topic as it describes that MBSR can be an effective

treatment option in treating symptoms associated with GAD patients.

Article Four

Wong et al. (2016) conducted a double-blind RCT examining how anxiety level changes

differ among patients with GAD in health clinics. Participants were randomly assigned to three

intervention groups: a mindfulness-based cognitive therapy (MBCT) group (n=61) led by trained

instructors, a CBT psychoeducation group (n=61) led by clinical psychologists, and a usual care

group (n=60) (Wong et al., 2016). Self-report assessments of primary outcomes, which include

anxiety symptoms as measured by the BAI and worry symptoms as measured by the Penn State

Worry Questionnaire (PSWQ); and secondary outcomes were collected at baseline, 2, and 5

months after baseline for all groups while the MBCT and psychoeducation groups were further
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followed at 8 and 11 months after baseline assessments (Wong et al., 2016). BAI scores for the

MBCT and psychoeducation groups were significantly lower from baseline at 2 and 5 months

after baseline with no changes noted in usual care group while significant changes in PSWQ

scores was only observed in psychoeducation group compared to usual care group at 5 months

after baseline (Wong et al., 2016). Significant decline in BAI and PSWQ scores were observed at

8 and 11 months after baseline in MBCT and psychoeducation groups with no significant

changes in BAI and PSWQ scores between the two intervention groups (Wong et al., 2016). The

authors noted a lower adherence in MBCT groups compared to psychoeducation, which could

have affected changes in anxiety and worry symptoms (Wong et al., 2016). The study included

only participants with moderate severity of GAD, so results cannot be generalized to those with

milder cases of GAD nor to all patients (Wong et al., 2016). All in all, Wong et al. found that

both MBCT and cognitive-behavioral therapy-based psychoeducation were both useful in the

reduction of anxiety levels compared to standard care.

Summary

In appraising four separate research articles, we found a lack of inclusion and exclusion

criteria in some studies and excessive amounts in others. For example, in Hazlett-Stevens (2020),

Sundquist et al. (2018), and Wong et al. (2016), participants reported concurrent medication

and/or therapy, which made it difficult to see if these interventions were responsible for

improvements among participants. On the other hand, Hoge et al. (2018) contained exclusion

criteria that created a small and uniform sample size. Additionally, another study limitation in the

research we examined found a lack of post-intervention data. Throughout all four articles,

adverse effects were not monitored during the studies. Some researchers seemed opposed to

discussing bias and limitations of their studies. MBCT was found to be clinically significant in
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decreasing levels of anxiety and stress in patients with moderate-severity GAD. After analyzing

four research articles, we feel as the Hoge et al. (2018) contains the best evidence in answering

our PICOT question. The other three articles relied on self-reported screening measures to

determine how well the MBSR therapies improved symptoms of GAD, whereas Hoge et al.

(2018) completed blood collections to determine an increase or decrease in stress hormones and

inflammatory factors. Self-reported screening measures are likely to contain bias because each

individual’s experiences with GAD are subjective. Biological markers from blood samples are

more reliable and contain no bias. Mindfulness-based therapy appears to be effective in reducing

anxiety and stress symptoms in patients diagnosed with GAD. Although MBSR appears to be

effective in improving symptoms in individuals with GAD, there is a lack of long-term studies

done.

Implications for Nursing Education, Research, and Practice

Nursing Education

Anxiety has many forms, and someone may not realize they are anxious, so part of

nursing education should include educating the patient and their family of the signs and

symptoms of anxiety, allowing them to intervene early on. This should be followed by coping

mechanisms for anxiety. Educating the client on the therapeutic and pharmacological treatments

to reduce their anxiety will give the patient an opportunity to choose the best option for

themselves.

Nursing Research

Within the clinical setting, GAD is commonly found among nurses, doctors, patients, and

families. Evidence-based practice helps to create a better understanding of MBSR on improving

psychological functioning, but lacks research pertaining to MBSR efficacy specifically within
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the hospital environment such as, operating and patient rooms. Furthermore, future research

should bring into focus the confounding variables associated with MBSR. It would provide great

value to nursing to recognize the different mechanisms that lead to changes in anxiety.

Nursing Practice

It is known that being in a medical setting can be anxiety inducing. Now that we have

researched the evidence in mindfulness meditation and MBSR therapies, they can be

implemented into the clinical environment. Instead of only using therapeutic communication

techniques, nurses can take a moment to teach and conduct mindfulness meditation that include

breathing exercises. Based on our clinical experience, therapeutic communication, and showing

kindness and empathy towards our clients has been helpful in conducting interviews in a calm

and safe manner. Through the research, we have learned about the effect of MBSR on patients

with GAD; we can improve the client’s health care experience through client education about

mindfulness techniques to help with stress and anxiety.

Conclusion

In the treatment of GAD, evidence proves MBSR therapies improve biological, physical,

and psychological symptoms related to GAD. Based on research done by Hoge et al. (2018),

mindfulness meditation training is a statistically significant strategy to decrease biological stress

reactivity and improve resilience to stressors in individuals with GAD. Wong et al. (2016)

concluded that MBCT was clinically significant for the reduction of anxiety symptoms in

patients with GAD. Hazlett-Stevens (2020) provides evidence that MBSR is an effective

treatment option for GAD patients seeking care in medical settings as statistically significant

reductions of stress and anxiety were found based on psychometric scales pre-to post-MSBR.

According to Sandquist et al. (2018), all four psychometric scales in the two groups were
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improved using mindfulness CBT and there were no significant differences in psychometric

scores between the MGT and TAU. Although our four research articles were able to answer our

PICOT question relatively well, we feel as though the small, distinct sample sizes may have

impacted the reliability of the studies. Furthermore, many of the study designs relied primarily

on self-report screening measures to determine GAD diagnosis and the efficacy of MBSR

therapy which served as a limitation throughout.

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References

Elsevier BV. (2021). Generalized anxiety disorder. Elsevier. Retrieved April 7, 2021 from

www.clinicalkey.com

Hazlett-Stevens, H. (2020). Generalized anxiety disorder symptom improvement following

mindfulness-based stress reduction in a general hospital setting. Journal of Medical

Psychology, 22(1), 21–29. https://doi.org/10.3233/jmp-170012

Hoge, E. A., Bui, E., Palitz, S. A., Schwarz, N. R., Owens, M. E., Johnston, J. M., Pollack, M.

H., Simon, N. M. (2018). The effect of mindfulness meditation training on biological

acute stress responses in generalized anxiety disorder. Psychiatry Research, 262, 328–

332. https://doi.org/10.1016/j.psychres.2017.01.006

UMass Memorial Medical Center. (n.d.). MBSR 8-week online live. UMass Memorial Health.

https://www.ummhealth.org/umass-memorial-medical-center/services-treatments/center-f

or-mindfulness/mindfulness-programs/mbsr-8-week-online-live.

Sundquist, J., Palmér, K., Memon, A. A., Wang, X., Johansson, L. M., & Sundquist, K. (2018).

Long-term improvements after mindfulness-based group therapy of depression, anxiety

and stress and adjustment disorders: A randomized controlled trial. Early Intervention in

Psychiatry, 13(4), 943–952. https://doi.org/10.1111/eip.12715

Wong, S. Y., Yip, B. H., Mak, W. W., Mercer, S., Cheung, E. Y., Ling, C. Y., Lui, W. W., Tang,

W. K., Lo, H. H., Wu, J. C., Lee, T. M., Gao, T., Griffiths, S. M., Chan, P. H., & Ma, H.

S. (2016). Mindfulness-based cognitive therapy v. group psychoeducation for people with

generalized anxiety disorder: Randomized controlled trial. British Journal of Psychiatry,

209(1), 68–75. https://doi.org/10.1192/bjp.bp.115.16612

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Table 1

Table of Evidence

Author(s) Questions, Variables Design, Results/Findings Level of

and Date Objectives, Hypothesis(es) Sample, Setting Evidence

Hoge, 2018 Question: What is the effect of Design: A Specific Outcome: Level II: 
United States MBSR on stress hormones cortisol randomized Mindfulness meditation Evidence was
and adrenocorticotropic (ACTH), controlled study.  training is significantly found through a
and inflammatory markers TNF-   significant strategy to well-designed
alpha and IL-6 compared to SME? Sample: 72 eligible decrease biological stress randomized
  (MBSR, n=43; SME, reactivity in individuals control trial.
Independent Variables: MBSR n=29). with GAD              
training course and SME program.     Strengths:
  Setting: MBSR was Statistical Values: Area- TSST data is
Dependent Variables: Hormone an 8-week group- under-the-curve (AUC) valuable and
levels measured during laboratory- based intervention calculations, little to no reliable
based Trier Social Stress Test with a single “retreat” change in cortisol levels  
(TSST). day and daily home between groups, MBSR Limitations:
  practice (breath- group had an overall Sample size,
Hypothesis: Mindfulness awareness, gentle reduction in ACTH AUC exclusion
meditation would mitigate yoga). SME was p=0.007, SME had an criteria, not clear
previously elevated responses to designed as a control overall increase as to why no
acute stress observed in intervention SME Both TNF-alpha and IL-6 significant
individuals with General anxiety course included had significant changes change in
disorder (GAD) through lowered lectures on overall (p=0.038 and p=0.036). cortisol AUC,
hormone levels and inflammatory health and did not did not include
markers. contain any potential
meditation or other confounds
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mind-body
intervention.

Question: Can MGT help a higher Design: RCT Level II:

number of patients with depressive, Evidence
Sandquist, Palmer, anxiety and stress and adjustment Results: There were no obtained from at
Memon, Wang, disorders in primary healthcare than Measures: Four significant differences in least one well-
Johansson, individualized psychotherapies? psychometric self- psychometric scores between designed
Sandquist rated scales after 8 the MGT and TAU at the 1- Randomized
weeks of treatment. year follow-up. Controlled Trial
Independent Variable: A control Then after 12 months, (RCT).
group with patients seeking the same scales were Strengths: data
03 July 2018 treatment for depression, anxiety or repeated.  was compiled into
stress, and adjustment disorders generalized
receive treatment as usual (TAU). linear-mixed
Sample: N=215 models, adjusted
for cluster effects,
Dependent Variable: A group of allowing for all
patients seeking treatment for Setting: Primary data to be used,
depression, anxiety or stress, and healthcare centers in including those
adjustment disorders receive MGT. southern Sweden who dropped out
of the study.

Hypothesis: the scores on four Limitations:

psychometric scales would be immigrants who
improved in both groups at the 1‐ could not speak
year follow‐up and that there would Swedish fluently
be no significant differences were not included
between the mindfulness and TAU in the RC
groups in this improvement.
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Hazlett-Stevens, Question: What proportion of
Holly  patients already enrolled in a
  general hospital MSBR program
2020 presented with symptoms of GAD
and are these symptoms reduced
after the implementation of MBSR
United States in large diagnostically
heterogeneous groups?
Independent variable: Hospital
MBSR program
Dependent variable: Symptoms of
GAD
Hypothesis: MBSR appears
promising for GAD patients in the
medical setting.
Wong, S. Y., Yip, Question: How do anxiety levels
B. H., Mak, W. change among participants with
W., Mercer, S., GAD during mindfulness-based
Cheung, E. Y., cognitive therapy (MBCT)
Ling, C. Y., Lui, compared to cognitive-behavioral
W. W., Tang, W. therapy-based psychoeducation
Design: RCT Results: MBSR delivered in Level II:
hospital settings may Evidence
Preliminary analyses provide an acceptable and obtained from at
were conducted.   effective treatment option least one well-
for GAD patients seeking designed
care in hospital settings  Randomized
Self-report Scales: Controlled Trial
GAD-7, Penn State (RCT)
Worry Questionnaire, Statistically significant
and Anxiety and Stress reductions pre to post-
scales at the first MBSR were found on the Strength:
MBSR session and the GAD-7 (Cohen’s d =1.95), Naturalistic
end of the course.  Penn State Worry design of study.
Questionnaire (Cohen’s d =
0.76) and the DASS21
Sample: N=65 Anxiety (Cohen’s d = 0.71) Limitations:
and Stress (Cohen’s d = Self-report
1.31) scales.  measures,
Setting: A general inclusion and
hospital in the Silicon exclusion criteria,
Valley lack of post-
intervention data.
Design: RCT with 3 Statistical Analysis:  Linear Level II:
groups of participants mixed models (LMM) used Evidence from a
(MBCT, Statistical Analysis:  Linear well-designed
psychoeducation mixed models (LMM) used RCT
group, usual care to investigate changes over  
group) followed for 5 time. Estimated means and Strengths:
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K., Lo, H. H., Wu, and usual care? months after baseline 95% confidence intervals Randomization,
J. C., Lee, T. M.,   assessment. Self- were calculated to show double-blind
Gao, T., Griffiths, Independent variable: MBCT vs. report assessments changes in outcomes. study using
S. M., Chan, P. H., cognitive-behavioral therapy- were administered at validated scales
& Ma, H. S. based psychoeducation vs. usual baseline, 2 months  
care after, and 5 months Results: BAI significant Limitations:
2016   after baseline. The 2 score changes: MBCT X 2 Lower adherence
Dependent variable: Anxiety and intervention groups months post = -5.05 (-8.72 to in MBCT group
Hong Kong
worry levels were followed for an -1.38); MBCT X 5 months compared to
  additional 6 months. post = -6.60 (-10.33 to - psychoeducation,
Hypothesis: Participants in the Follow up 2.87); psychoeducation X 2 could have
MBCT group will have lower assessments were months post = -4.86 (-8.53 to affected changes
levels of anxiety and worry than performed at 8 and 11 -1.19); psychoeducation X 5 in symptoms;
those in the psychoeducation months after baseline months post = -7.95 (-11.52 participants had
group and those in the usual care assessments. to -4.37) moderate-
control group     severity GAD,
Sample: MBCT group PSWQ significant score results cannot be
(n=61), change: psychoeducation X generalized to
psychoeducation 5 months post = -4.24 (-7.98 those with
group (n=61), and to -0.51) milder cases nor
usual care group to all patients; all
(n=60) Both MBCT and data collected
  psychoeducation were better were self-
Setting: Clinical care than usual care for the reported, no
centers reduction of anxiety among clinician-rate
participants. The differences instruments used
in outcomes between the 2 at follow-ups
intervention groups was
small and likely has limited
clinical significance.
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Reference of hierarchy of evidence: Melnyk and Fineout-Overholt, 2019.