Toward Exercise as Medicine for Adolescents With Bipolar Disorder

NCT03562520 | Terminated DMC

• 1 other identifier: 007-2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Aerobic fitness; Aerobic exercise; Behavior change counseling

Outcome Measures

Primary Outcomes (32)

• Barriers to participation using the Client Satisfaction Questionnaire

  Week 12

• Barriers to participation using the Client Satisfaction Questionnaire

  Week 24

• Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire

  Week 12

• Satisfaction of patient, parent, and consumer advocate co-investigators using the Client Satisfaction Questionnaire

  Week 24

• Percentage of target sample size enrolled

  three years (At the end of study completion)

• Percentage of screened participants meeting inclusion criteria comparing number of participants screened to number of participants who meet inclusion criteria

  Evaluating whether sample reflects clinical population in which exercise is an anticipated intervention

  Three years

• Barriers to recruitment

  Qualitative assessment using phenomenological approach

  Three years

• Therapist adherence with behavior change counseling using the Behavior Change Counseling Index

  three years

• Participant attendance

  Attendance at core sessions

  Week 0

• Participant attendance

  Attendance at core sessions

  Week 4

• Participant attendance

  Attendance at core sessions

  Week 8

• Participant attendance

  Attendance at core sessions

  Week 12

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 1

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 2

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 3

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 5

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 6

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 7

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 9

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 10

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 11

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 16

• Participant attendance

  Attendance at phone calls/texting sessions

  Week 20

• Participant completion of daily activity logs

  Number of daily activity logs completed for each participant

  three years

• Participant attendance

  Attendance at exercise coaching session

  Week 1

• Percentage of participants who selected the exercise coaching optional module

  three years

• Percentage of participants who selected the family focused counseling optional module

  three years

• Percentage of participants who selected the peer support optional module

  three years

• Percentage of participants who completed the 24 weeks of the study

  three years

• Percentage of participants who completed the 12 week intervention

  three years

• Percentage of participants who completed all aerobic fitness testing sessions

  three years

• Percentage of sessions attended by each team member

  three years

Secondary Outcomes (19)

• Change in aerobic fitness using the Modified Bruce Protocol

  From week 0 to week 12

• Change in aerobic fitness using the Modified Bruce Protocol

  From week 12 to week 24

• Change in aerobic fitness using the Modified Canadian Aerobic Fitness Test

  From week 2 to week 8

• Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)

  baseline

• Longitudinal Interval Follow-up Evaluation (LIFE)

  baseline, week 12, week 24

Study Arms (1)

Adolescents with bipolar disorder

EXPERIMENTAL

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.

Behavioral: Behavior change counseling

Interventions

Behavior change counseling 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.

Adolescents with bipolar disorder

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English-speaking
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University of British Columbia: collaborator
• The Hospital for Sick Children: collaborator
• Mood Disorders Association of Ontario: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Benjamin I Goldstein, MD, PhD

  Senior Scientist, Psychiatrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Psychiatrist

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: June 19, 2018
• Study Start: June 15, 2018
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)