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

NCT ID: NCT04026152

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-14
• Study Completion Date: 2020-09-01

Brief 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.

Detailed 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.

Conditions

Anxiety Disorders; Posttraumatic Stress Disorder; Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistance training + Unified Protocol

Participants randomly assigned to this condition will complete a resistance training program consisting of three weekly hour-long full body exercise sessions. Participants will also receive four weekly hour-long sessions with a therapist to learn cognitive-behavioural strategies to assist them with managing their anxiety when exercising. Participants will be supported by a personal trainer for six exercise session during their first month of training and will complete the remaining six sessions during this month independently. Participants will then continue to exercise independently following this first month of intervention. Participants will fill out weekly self-report measures (\~20 minutes each time) via the internet during their first four weeks of study participation and at 1-week, 1-month, and 3-months (\~20 minutes each time) follow-up after they have completed the supervised portion of this study.

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Resistance training

Participants randomly assigned to this condition will complete a resistance training program consisting of three weekly hour-long full body exercise sessions. Participants will be supported by a personal trainer for six exercise session during their first month of training and will complete the remaining six sessions during this month independently. Participants will then continue to exercise independently following this first month of intervention. Participants will fill out weekly self-report measures (\~20 minutes each time) via the internet during their first four weeks of study participation and at 1-week, 1-month, and 3-months (\~20 minutes each time) follow-up after they have completed the supervised portion of this study.

Group Type: ACTIVE_COMPARATOR

Resistance training

Intervention Type: BEHAVIORAL

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.

Waitlist

Participants randomly assigned to this condition will maintain their usual physical activity and exercise routine and not engage in any additional exercise than they were prior to the study. These participants will fill out questionnaires (\~20 minutes each time) following randomization into this condition, once per week for four weeks, and at 1-week, 1-month, and 3-months (\~20 minutes each time) follow-up. After completing the last follow-up, participants in the waitlist condition will be re-randomized into either the resistance training only or resistance training + Unified Protocol conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise; Cognitive-behavioural therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Mason, MA

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

University of Regina

Regina, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 27993336 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23931656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23300122 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28768327 (View on PubMed)

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. doi: 10.1097/01.nmd.0000253730.31610.6c.

Reference Type: BACKGROUND

PMID: 17568300 (View on PubMed)

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. doi: 10.1016/j.cpr.2004.06.001.

Reference Type: BACKGROUND

PMID: 15325746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29049901 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

2019-048

Identifier Type: -

Identifier Source: org_study_id