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

NCT04026152 | Completed

• 1 other identifier: 2019-048
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Posttraumatic Stress Disorder; Obsessive-Compulsive Disorder

Keywords

Anxiety-Related Disorder; Exercise; Resistance Training; Unified Protocol; Adherence; Randomized Controlled Trial; Physical Activity

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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

• 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

• 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 Outcomes (4)

• Exercise self-efficacy (change)

  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

• Exercise knowledge (change)

  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

• Exercise motivation (change)

  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

• Pandemic measures

  At 1-week, 1-month, and 3-month follow-up for participants who participated during the pandemic.

Study Arms (3)

Resistance training + Unified Protocol

EXPERIMENTAL

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.

Behavioral: Resistance training; Behavioral: Unified Protocol

Resistance training

ACTIVE COMPARATOR

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.

Behavioral: Resistance training

Waitlist

NO INTERVENTION

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.

Interventions

Resistance training 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.

Also known as: Exercise

Resistance training; Resistance training + Unified Protocol

Unified Protocol 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.

Also known as: Cognitive-behavioural therapy

Resistance training + Unified Protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (8)

• 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.

  PMID: 27993336 BACKGROUND

• 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.

  PMID: 23931656 BACKGROUND

• 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.

  PMID: 23300122 BACKGROUND

• 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.

  PMID: 28768327 BACKGROUND

• 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.

  PMID: 17568300 BACKGROUND

• 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.

  PMID: 15325746 BACKGROUND

• 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.

  PMID: 29049901 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Motor Activity

Interventions

Resistance Training; Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Julia Mason, MA

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be aware of the three study conditions in order to provide informed consent for participation; however, they will not receive detailed information or materials about any condition until they have been assigned to it. The personal trainers who will be administering the resistance training sessions do not know about the presence of the waitlist or resistance training + Unified Protocol conditions. The therapist who is administering the Unified Protocol will be aware of all conditions. The Outcomes Assessor and Investigator will also be aware of all conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of three conditions: resistance training plus Unified Protocol, resistance training, or waitlist. Participants will then complete their assigned condition. Participants who receive the waitlist condition will have the option to be re-randomized into one of the resistance training conditions after they have completed their last waitlist measure.

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 19, 2019
• Study Start: July 14, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)