Exercising With Anxiety: Can Cognitive Behavioural Techniques Help People With Anxiety-related Disorders Exercise More?

Anxiety Disorders Clinical Trial

Official title:

Using the Unified Protocol to Reduce Exercise Anxiety and Improve Adherence to a Resistance Training Program for People With Anxiety-Related Disorders: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026152
• Other study ID #: 2019-048
• Status: Completed
• Phase: N/A
• Start date: July 14, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2019
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anxiety-related disorders such as panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder are among the most prevalent mental health disorders affecting Canadian adults. Lack of access to evidence-based treatments prevents many people with high levels of anxiety from receiving appropriate care. Evidence shows that exercise is an alternative option for alleviating anxiety that could be appealing to individuals with high levels of anxiety who are unable, or unwilling, to access other evidence-based treatments. Unfortunately, people with high levels of anxiety tend to have a hard time using exercise independently as a strategy to manage their anxiety, in part, because many aspects of exercising can be anxiety-provoking (e.g., physical sensations produced by exercise, opportunities for evaluation by others, crowded exercise environments). Cognitive-behavioral techniques are therapeutic tools that could help these people overcome their anxiety about exercising and support them as they make positive health behavioural changes; however, however, no study to date has explored this possibility. The proposed study will use rigorous experimental techniques to determine whether an exercise-focused cognitive behavioural psychological intervention can support people with anxiety-related disorders to become more physically active and experience the reductions in anxiety that comes from making this lifestyle change.

Description:

Exercise is a time- and cost-efficient alternative to other evidence-based treatments for anxiety (e.g., psychotherapy, pharmaceutical) that also is associated with physical health benefits. Exercise protocols such as resistance training (RT) are efficacious at reducing symptoms of anxiety-related disorders (ARDs); however, there are challenges associated with effectively implementing such protocols, most notably, that people with ARDs may avoid physical activity, including exercise. Emerging research suggests that people with ARDs experience exercise-specific anxiety (e.g., exercise-related worries, fear of physical sensations associated with exercise) and identify this exercise anxiety as a major contributor to their exercise avoidance. Consequently, exercise interventions for people with ARDs may need to target exercise anxiety to support long-term exercise engagement. Evidence-based cognitive-behavioural techniques (CBT), such as cognitive restructuring, and exposure, can alter maladaptive thinking and behavioural patterns associated with anxiety. Teaching people with ARDs how to apply CBT techniques to exercise anxiety could help increase and support their exercise behaviour; however, research has not been conducted to test this hypothesis. The primary purpose of this proposed randomized controlled trial (RCT) is to examine whether adding a form of CBT (i.e., the Unified Protocol) to a program for people with ARDs is associated with superior exercise engagement as compared to groups that do not receive this intervention. This proposed RCT will also evaluate potential predictors of exercise frequency for people with ARDs, such as exercise knowledge, exercise self-efficacy, and exercise motivation. A total of 90 physically inactive participants with ARDs will be randomized into a month of one of the following conditions: Unified Protocol + RT, RT, or waitlist (WL). All participants (except WL) will receive and follow a comprehensive instructional exercise program, consisting of three weekly full body RT workouts. Participants in both RT groups will also receive the guidance of a personal trainer during their first month of following this program. Participants in both RT groups will complete three exercise sessions each week for 4 weeks and these sessions will be composed of personal trainer and independent exercise. Participants in the Unified Protocol +RT condition will also receive four weekly individual CBT sessions designed to support adherence to the exercise sessions. Exercise frequency will be measured using the number of recorded exercise sessions (at least 30 minutes in length) and physical activity will be measured using the International Physical Activity Questionnaire-Short Form. Presence and severity of ARDs will be assessed using the Structured Clinical Administered Interview for the Diagnostic Statistical Manual of Mental Disorders-5 (SCID-5) as well as disorder-specific self-report measures. Exercise anxiety will also be measured using a questionnaire designed for this study. Exercise frequency, anxiety disorder-specific severity, and exercise anxiety will be measured at baseline, weekly during the first month of exercise, and at follow-up at 1-week, 1-month, and 3-months. Diagnostic status will be evaluated at baseline and at 1-week follow-up. Exercise knowledge, exercise self-efficacy, exercise motivation, and physical activity, will be measured at baseline, 1-week-, 1-month-, and 3-month follow-ups. Multilevel modelling will compare exercise frequency and anxiety symptoms, across groups, at each time point. This RCT will be the first to evaluate whether the Unified Protocol can support people with ARDs to increase their exercise engagement. If the Unified Protocol does increase engagement, the Unified Protocol could be used by researchers and clinicians alike to support individuals with ARDs interested in using exercise to manage their anxiety, but who are experiencing difficulty maintaining an exercise regime.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of specific phobia, agoraphobia, social anxiety disorder, generalized anxiety disorder, panic disorder, posttraumatic stress disorder, obsessive-compulsive disorder, other specified anxiety disorder, other specified obsessive-compulsive disorder, and other specified trauma- and stressor-related disorder.

• Reports experiencing anxiety about exercising

Exclusion Criteria:

• Current enrolment in cognitive-behaviour therapy

• Comorbid substance use disorder

• Taking benzodiazepines or antipsychotic medication

• At risk for suicide

• Engages in an average of four or more resistance training exercise sessions each month

• Completes 150 minutes of moderate intensity physical activity or 75 minutes of vigorous intensity physical activity each week

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Obsessive-Compulsive Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Resistance training
Following randomization, all participants assigned to receive the resistance training intervention will receive a comprehensive exercise program. The exercise program participants will be using is similar to past research using resistance training programs with people with anxiety-related disorders and has been developed and reviewed by a team of certified personal trainers, including the primary investigator. All participants assigned receive this resistance training intervention will complete a total of six sessions with a personal trainer and six session independently over four weeks to allow for a gradual, rather than abrupt, transition to fully independently completed exercise by the 4th week. After this time participants will be encouraged to exercise independently.
• Unified Protocol
This intervention consists four weekly sessions adapted from the Unified Protocol. The first module is Psychoeducation and Motivational Interviewing. During this module, participants will develop an understanding of their own pattern of emotional responding to exercise as well as increasing participants' readiness and motivation for behaviour change.The second module is Cognitive Flexibility, during which participants will learn about how automatic negative interpretations can influence their emotional reactions and prevent them from considering alternative explanations. The third module is Countering Emotion-Driven Behaviours during which participants will identify and counter behaviours used to dampen strong emotions, particularly those associated with exercise. Lastly, module four will use Exposure to external and internal emotional triggers to increase participants' tolerance to the emotions that arise in exercise environments.

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Andrade LH, Alonso J, Mneimneh Z, Wells JE, Al-Hamzawi A, Borges G, Bromet E, Bruffaerts R, de Girolamo G, de Graaf R, Florescu S, Gureje O, Hinkov HR, Hu C, Huang Y, Hwang I, Jin R, Karam EG, Kovess-Masfety V, Levinson D, Matschinger H, O'Neill S, Posada-Villa J, Sagar R, Sampson NA, Sasu C, Stein DJ, Takeshima T, Viana MC, Xavier M, Kessler RC. Barriers to mental health treatment: results from the WHO World Mental Health surveys. Psychol Med. 2014 Apr;44(6):1303-17. doi: 10.1017/S0033291713001943. Epub 2013 Aug 9. — View Citation

Asmundson GJ, Fetzner MG, Deboer LB, Powers MB, Otto MW, Smits JA. Let's get physical: a contemporary review of the anxiolytic effects of exercise for anxiety and its disorders. Depress Anxiety. 2013 Apr;30(4):362-73. doi: 10.1002/da.22043. Epub 2013 Jan 8. Review. — View Citation

Barlow DH, Allen LB, Choate ML. Toward a Unified Treatment for Emotional Disorders - Republished Article. Behav Ther. 2016 Nov;47(6):838-853. doi: 10.1016/j.beth.2016.11.005. Epub 2016 Nov 10. — View Citation

Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164. — View Citation

Brown RA, Abrantes AM, Strong DR, Mancebo MC, Menard J, Rasmussen SA, Greenberg BD. A pilot study of moderate-intensity aerobic exercise for obsessive compulsive disorder. J Nerv Ment Dis. 2007 Jun;195(6):514-20. — View Citation

Collins KA, Westra HA, Dozois DJ, Burns DD. Gaps in accessing treatment for anxiety and depression: challenges for the delivery of care. Clin Psychol Rev. 2004 Sep;24(5):583-616. Review. — View Citation

LeBouthillier DM, Asmundson GJG. The efficacy of aerobic exercise and resistance training as transdiagnostic interventions for anxiety-related disorders and constructs: A randomized controlled trial. J Anxiety Disord. 2017 Dec;52:43-52. doi: 10.1016/j.janxdis.2017.09.005. Epub 2017 Sep 23. — View Citation

Mason, J. E., Faller, Y. N., LeBouthillier, D. M., & Asmundson, G. J. G. (2018). Exercise anxiety: A qualitative analysis of the barriers, facilitators, and psychological processes underlying exercise participation for people with anxiety-related disorders. Mental Health and Physical Activity. https://doi.org/10.1016/J.MHPA.2018.11.003

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety severity (change)	Participants will complete one of the following empirically validated clinical symptom measures for their primary anxiety disorder to assess whether any changes occur from baseline to the last follow-up. Higher scores on these measures indicate more severe symptoms. The Severity Measure for Specific Phobia-Adult (SMSP-A), The Severity Measure for Agoraphobia-Adult (SMA-A), The Social Interaction Phobia Scale (SIPS), The Panic Disorder Severity Scale-Self Report (PDSS-SR), The Generalized Anxiety Disorder 7-item scale (GAD-7), The Obsessive-Compulsive Inventory-Revised (OCI-R), The Posttraumatic Stress Disorder Checklist for the Diagnostic Statistical Manual of Mental Disorders-5(PCL-5), and The Depression Anxiety and Stress 21-item (DASS-21). T scores based on means and standard deviations from non-clinical samples will be calculated and used for comparisons.	There are eight time points where this measure will be taken, namely (1) baseline, (2) week 1, (3) week 2, (4) week 3, (5) week 4, (6) 1-week follow-up, (7) 1-month follow-up, and (8) 3-month follow-up
Primary	Anxiety diagnostic status (change)	The Structured Clinician Administered Interview for the Diagnostic Statistical Manual of Mental Disorders-5, Research Version (SCID-5-RV) will be administered twice during this study to assess for determine participant eligibility for the study and to evaluate potential changes in diagnostic status following intervention. Participants that meet criteria for a primary diagnosis of specific phobia, agoraphobia, social anxiety disorder, generalized anxiety disorder, panic disorder, posttraumatic disorder, obsessive-compulsive disorder, other specified anxiety disorder, other specified obsessive-compulsive disorder, or other specified trauma-and stressor-related disorder, will be eligible to participate in this study. Diagnostic status will be reassessed at the 1-week follow-up to determine if changes in diagnostic status have occured.	There are two time points where this measure will be taken, namely (1) eligibility assessment and (2) 1-week follow-up. UPDATE: During the actual trial (to minimize participant burden) we only used this measure for the eligibility assessment.
Primary	Exercise frequency (change)	Exercise frequency will be measured using the number of 30 minute (or longer) exercise sessions completed by participants across time to determine if any changes in exercise frequency occur with study participation. The greater the scores on this measure, the more participants have been exercising. This data will be collected using participant tracking logs. Participants will complete an exercise log entry in their manual every time they exercise and these workouts will be verified using the date/time stamps collected whenever they scan their membership card at the gym in order to access it. Participants will also note any workouts that they complete outside the gym in their tracking logs. UPDATE: due to gym closures from the COVID-19 pandemic, we were unable to collect time-stamped frequency data. We used self-report exercise logs for this measure.	There are eight time points where this measure will be taken, namely (1) baseline, (2) week 1, (3) week 2, (4) week 3, (5) week 4, (6) 1-week follow-up, (7) 1-month follow-up, and (8) 3-month follow-up
Primary	Exercise anxiety (change)	The Exercise Anxiety Questionnaire is a 16-item scale that was developed for the purpose of this study to evaluate whether any changes in exercise anxiety occur with participation in this study and whether these changes are associated with exercise behaviour. Items on this measure evaluate participants' experience with exercise anxiety and the effect that this anxiety has on their exercise behaviour. Items will be rated on a Likert Scale ranging from 0 (not at all) to 4 (agree very much). Items will be summed to generate total exercise anxiety scores where higher scores indicate greater exercise anxiety.	There are eight time points where this measure will be taken, namely (1) baseline, (2) week 1, (3) week 2, (4) week 3, (5) week 4, (6) 1-week follow-up, (7) 1-month follow-up, and (8) 3-month follow-up
Primary	Physical activity (change)	The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is the abbreviated version of a self-report tool for monitoring physical activity levels. The IPAQ-SF assesses physical activity over the last 7 days across four domains (i.e., during leisure time, domestic activities, occupation, and transportation, and with three intensities (i.e., low, moderate, and vigorous). Data collected from the IPAQ-SF can be reported as a continuous weekly total energy expenditure or metabolic equivalents (METs). This measure will be used to produce a total score of weekly METs-minutes/week across time in order to determine whether any changes in physical activity occur with participation in this study.	There are four time points where this measure will be taken, namely (1) baseline, (2) 1-week follow-up, (3) 1-month follow-up, and (4) 3-month follow-up
Secondary	Exercise self-efficacy (change)	The Self-Efficacy to Regulate Exercise Scale (SES) is an 18-item exercise self-efficacy self-report measure. When completing this measure, participants are required to rate how certain they are that they would be able to perform their exercise routine regularly (three or more times per week) under situations that can make it hard to stick to an exercise routine. Participants provide rating using a Likert scale ranging from 0 (cannot do at all) to 100 (highly certain can do). Items are summed together to provide a total exercise self-efficacy score, with higher scores indicating greater self-efficacy. This measure will be administered several times during this study to determine whether any changes in exercise self-efficacy occur.	There are four time points where this measure will be taken, namely (1) baseline, (2) 1-week follow-up, (3) 1-month follow-up, and (4) 3-month follow-up
Secondary	Exercise knowledge (change)	Participants' knowledge about basic fitness principles, primal movement patterns, and cardiorespiratory and muscular concepts will be evaluated using The Exercise and Physical Activity Knowledge Quiz. This measure was developed for this study and has not been empirically validated. Each question will be answered with either true or false and will be worth one point for correct scores. Scores on each question will be summed to generate a total score with higher scores indicating more exercise knowledge. This measure will be administered at several time points during this study to evaluate whether any changes in exercise knowledge have occured.	There are four time points where this measure will be taken, namely (1) baseline, (2) 1-week follow-up, (3) 1-month follow-up, and (4) 3-month follow-up. UPDATE: The data collected from this measure was not usable and we were unable to include it
Secondary	Exercise motivation (change)	The Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2) is a 19-item self-report measure of five motivational factors for exercise rated on a Likert Scale ranging from 0 (not true for me) to 10 (very true for me). This measure is scored by calculating a mean score for each of the following factors with higher scores indicating responses more consistent with the factor, external regulation (i.e., satisfy external pressures or achieve external rewards), identification (i.e., acceptance of the value of exercise), introjection (i.e., internalization of external controls to avoid negative emotional states), intrinsic regulation (i.e., taking part in exercise for the enjoyment and satisfaction inherent in engaging in the behaviour), and amotivation (i.e., lacking intention to engage in exercise). This measure will be administered throughout this study to evaluate changes in exercise motivation.	There are four time points where this measure will be taken, namely (1) baseline, (2) 1-week follow-up, (3) 1-month follow-up, and (4) 3-month follow-up
Secondary	Pandemic measures	After the onset of the ongoing global coronavirus pandemic we received research ethics board approval to ask participants about the effect of the pandemic on their mental health and exercise behaviour. Qualitative responses were provided by participants.	At 1-week, 1-month, and 3-month follow-up for participants who participated during the pandemic.