Toward Exercise as Medicine for Adolescents With Bipolar Disorder

NCT ID: NCT03562520

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2020-08-21

Brief Summary

This study seeks to bridge the knowledge-to-action gap regarding "exercise as medicine" for adolescents with bipolar disorder (BD). Numerous review articles attest to widespread recognition that aerobic exercise (AE) could be an important part of the treatment armamentarium to reduce the symptom burden, neurocognitive dysfunction, and cardiovascular disease (CVD) risk, improve quality of life (QOL), and even engage core biological treatment targets in BD. It appears self-evident that treatment for adolescents with BD, who experience high symptom burden, neurocognitive deficits, and increased CVD risk, should target their aerobic fitness (AF), yet there is not a single study in the world literature on this topic. Remarkably, there have been no intervention studies that specifically focus on aerobic exercise or that directly evaluate changes in AF in any BD age group. Overall physical activity is important, but focusing on AF offers unique potential benefits in terms of simultaneously ameliorating and enhancing mood, neurocognition, and cardiovascular health. Importantly, a recent American Heart Association (AHA) Scientific Statement confirms that it is the most aerobically unfit for whom even modest improvements in AF offer the greatest relative benefits. Nonetheless, important questions arise as to whether and how AF in this population can be improved. There is a clear and unmet need for effective behavior change counseling (BCC) interventions targeting AF that are tailored to the unique needs of adolescents with BD.

Detailed Description

The overarching goal of this project is to advance the field in terms of BCC approaches to improving AF among adolescents with BD, a group for whom improvements in AF offer multiple parallel benefits. This project will serve as a preliminary feasibility study, a necessary step in the path toward a well-powered, randomized controlled trial (RCT). If exercise is to achieve the same status as other evidence-based treatments for adolescents with BD, it will be necessary to evaluate exercise with the same level of rigor as other interventions. A crucial first step toward the ultimate goal of an adequately powered RCT is to demonstrate that adolescents with BD will enroll in, and actively participate in, an intervention study that accurately reflects what would be required of participants in such a study.

Objective 1: Evaluate the feasibility of developing a 24-week BCC intervention, customized and personalized for adolescents with BD, focusing on increasing AF.

Objective 2: Evaluate the feasibility of implementing the 24-week BCC intervention.

Objective 3: Evaluate the feasibility of measuring the effects of the intervention.

Exploratory: Examine the impact on AF of a 24-week BCC intervention, customized and personalized for adolescents with BD. Related hypothesis-generating analyses will examine the impact of specific variables (e.g., mood, medications, exercise-induced feelings, specific BCC modules, changes in motivation and self-efficacy) on AF changes.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adolescents with bipolar disorder

Forty adolescents (aged 13-21) with BD (type I, II, or not otherwise specified/other specified and related disorder) will be enrolled in the behavior change counseling intervention.

Group Type: EXPERIMENTAL

Behavior change counseling

Intervention Type: BEHAVIORAL

Core modules: 1 psychoeducation session at week 0; 4 behavior change counseling (BCC) sessions will occur at weeks 0, 4, 8, and 12; phone calls and/or texting sessions (weeks 1-3, 5-7, 9-11, and "booster" calls and/or texts on weeks 16 and 20) from therapists.

Optional modules: Exercise coaching sessions; family involvement options will include participation in any aspect of the intervention; peer support options will include: group exercise classes on site, online Fitbit groups where adolescents can participate in competitions with each other and provide motivational support, and fitness support groups facilitated by registered social workers.

Interventions

Behavior change counseling

Core modules: 1 psychoeducation session at week 0; 4 behavior change counseling (BCC) sessions will occur at weeks 0, 4, 8, and 12; phone calls and/or texting sessions (weeks 1-3, 5-7, 9-11, and "booster" calls and/or texts on weeks 16 and 20) from therapists.

Optional modules: Exercise coaching sessions; family involvement options will include participation in any aspect of the intervention; peer support options will include: group exercise classes on site, online Fitbit groups where adolescents can participate in competitions with each other and provide motivational support, and fitness support groups facilitated by registered social workers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English-speaking
• 13-21 years old
• Meet diagnostic criteria for BD (using KSADS-PL)
• Report moderate-vigorous exercise <150 minutes/week in the preceding 12 weeks
• Written clearance from primary care physician required

Exclusion Criteria

• Unable to provide informed consent (e.g., severe psychosis, IQ<80)
• Presence of hypo/hypertension and history of exercise induced and aggravated conditions that are contraindications to proceeding with the study (e.g., syncope, asthma)
• Known cardiac condition (e.g., conduction abnormality, congenital heart disease) or other active medical condition that precludes aerobic exercise
• Known respiratory condition that precludes aerobic exercise
• Known health condition of physiological impairment that would preclude participation in exercise
• Currently manic (PSR score of 5 or 6 on mania)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Mood Disorders Association of Ontario

UNKNOWN

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benjamin Goldstein

Senior Scientist, Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin I Goldstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior Scientist, Psychiatrist

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

007-2018

Identifier Type: -

Identifier Source: org_study_id