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Bipolar DisorderTEAM-BDNCT03562520

Toward Exercise as Medicine for Adolescents With Bipolar Disorder

A study testing Behavior change counseling in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 21 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Behavior change counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
15 Jun 2018to 21 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Toward Exercise as Medicine for Adolescents With Bipolar Disorder: A Feasibility Study

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.

Read the 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.

Being tested
Behavior change counseling
Keywords
Aerobic fitness, Aerobic exercise, Behavior change counseling
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavior change counselingBehavioural

    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.

Study groups in NCT03562520
Study groupRoleWhat they receive
Adolescents with bipolar disorderExperimentalForty 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.
Receives: Behavioral: Behavior change counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Barriers to participation using the Client Satisfaction Questionnaire

    Measured: Week 12

  2. Barriers to participation using the Client Satisfaction Questionnaire

    Measured: Week 24

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

    Measured: Week 12

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

    Measured: Week 24

  5. Percentage of target sample size enrolled

    Measured: three years (At the end of study completion)

  6. 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

    Measured: Three years

  7. Barriers to recruitment

    Qualitative assessment using phenomenological approach

    Measured: Three years

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

    Measured: three years

  9. Participant attendance

    Attendance at core sessions

    Measured: Week 0

  10. Participant attendance

    Attendance at core sessions

    Measured: Week 4

  11. Participant attendance

    Attendance at core sessions

    Measured: Week 8

  12. Participant attendance

    Attendance at core sessions

    Measured: Week 12

  13. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 1

  14. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 2

  15. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 3

  16. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 5

  17. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 6

  18. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 7

  19. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 9

  20. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 10

  21. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 11

  22. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 16

  23. Participant attendance

    Attendance at phone calls/texting sessions

    Measured: Week 20

  24. Participant completion of daily activity logs

    Number of daily activity logs completed for each participant

    Measured: three years

  25. Participant attendance

    Attendance at exercise coaching session

    Measured: Week 1

  26. Percentage of participants who selected the exercise coaching optional module

    Measured: three years

  27. Percentage of participants who selected the family focused counseling optional module

    Measured: three years

  28. Percentage of participants who selected the peer support optional module

    Measured: three years

  29. Percentage of participants who completed the 24 weeks of the study

    Measured: three years

  30. Percentage of participants who completed the 12 week intervention

    Measured: three years

  31. Percentage of participants who completed all aerobic fitness testing sessions

    Measured: three years

  32. Percentage of sessions attended by each team member

    Measured: three years

Secondary outcomes (19)
  1. Change in aerobic fitness using the Modified Bruce Protocol

    The modified Bruce Treadmill Test (weeks 0, 12) progresses through stages every 3 minutes, with each stage increasing in incline of the treadmill platform and increasing speed of treadmill belt. The modified Bruce treadmill test will provide an estimation of VO2max based on treadmill time.

    Measured: From week 0 to week 12

  2. Change in aerobic fitness using the Modified Bruce Protocol

    The modified Bruce Treadmill Test (weeks 12, 24) progresses through stages every 3 minutes, with each stage increasing in incline of the treadmill platform and increasing speed of treadmill belt. The modified Bruce treadmill test will provide an estimation of VO2max based on treadmill time.

    Measured: From week 12 to week 24

  3. Change in aerobic fitness using the Modified Canadian Aerobic Fitness Test

    The modified Canadian AF Test (weeks 2, 8), consists of stepping up and down two steps (20.3 cm in height each) during 3-minute stages while listening to set cadences. The stepping rate will depend on age and sex, and participants will be required to reach a target heart rate of 85% of predicted maximum (220 - age). VO2 max will be estimated through the following equation: VO2 max = 32.5 +13.6 x estimated oxygen cost (L/min) - 0.24 x age - 0.17 x weight (Kg).

    Measured: From week 2 to week 8

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

    The K-SADS-PL is a semi-structured interview designed to ascertain present episode and lifetime history of psychiatric illness, according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for children and adolescents.

    Measured: baseline

  5. Longitudinal Interval Follow-up Evaluation (LIFE)

    The LIFE will provide a comprehensive cross-sectional and longitudinal picture of the symptomatic and psychosocial course and outcome of all participants in this study

    Measured: baseline, week 12, week 24

  6. Brief Quality of Life in Bipolar Disorder (QoL.BD)

    The Brief QoL.BD is a self-report that will be used to assess condition-specific quality of life. Scale responses include: strongly disagree, disagree, neutral, agree, and strongly agree. The scale assesses 12 basic domains of quality of life: physical, sleep, mood, cognition, leisure, social, spirituality, finances, household, self-esteem, independence, and identity. Total scores can range from 12-60 with 60 identifying a high quality of life.

    Measured: baseline, week 12, week 24

  7. 36-Item Short Form Health Survey (SF-36)

    The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. To score, first, precoded numeric values are recoded per the scoring key given (see link). Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating. https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html

    Measured: baseline, week 12, week 24

  8. Client Satisfaction Questionnaire-8 (CSQ-8)

    The Client Satisfaction Questionnaire-8 will be used to assess intervention satisfaction. An overall score is calculated by summing the respondent's rating (item rating) score for each scale item. For the CSQ-8 version, scores therefore range from 8 to 32, with higher values indicating higher satisfaction. Scoring values range from 1-4 with 4 meaning high satisfaction and 1 meaning low satisfaction.

    Measured: At weeks 12 and 24

  9. The Stages of Change Questionnaire (SCQ)

    The Stages of Change Questionnaire is a self-report that will provide the stage of behavior change relating to exercise status for discussion at BCC sessions. Six statements are provided and the participant is asked to select the statement that best describes them. This will then determine which stage of change they are in (precontemplation, contemplation, preparation, action, maintenance, or relapse).

    Measured: baseline, week 4, week 8, week 12, and week 24

  10. Outcome Expectations for Exercise (OEE)

    The Outcome Expectations for Exercise tool will assess expectations of the benefits from physical activity. The Outcome Expectations for Exercise Scale contains 9 statements rated by participants using a 5-point likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree". If negative or low expectations are found, an intervention can be implemented that may increase the expectancy of exercise and therefore create a more active lifestyle.

    Measured: baseline, week 12, week 24

  11. Motives for Physical Activities Measure-Revised (MPAM-R)

    The MPAM-R will assess motives for activity participation. There are five categories: interest/enjoyment, competence, appearance, fitness, and social. It is rated on a likert scale ranging from 1 (not at all true for me) to 7 (very true for me).

    Measured: baseline, week 12, week 24

  12. Behavioral Regulation in Exercise Questionnaire (BREQ-3)

    The Behavioral Regulation in Exercise Questionnaire-3 is a 24-item self-report scale that assesses the reasons why people exercise. Questions range from 0 (not true for me) to 4 (very true for me). BREQ has been used either as a multidimensional instrument giving separate scores for each subscale, or as a unidimensional index of the degree of self-determination, known as the relative autonomy index. In order to use the BREQ as multidimensional scales, the mean scores are calculated for each set of items into categories (amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation).

    Measured: baseline, week 12, week 24

  13. Exercise Self-Efficacy

    This measure will assess exercise-related self-efficacy. An 11-point scale is used with 1 indicating "not at all confident" and 7 indicating "very confident". Participants can also endorse 0 "does not apply to me". High scores indicate high levels of self-efficacy.

    Measured: baseline, week 12, week 24

  14. Quick Weight, Activity, Variety, and Excess Screener (WAVE)

    WAVE is a 17-item self-report instrument that ascertains 5 subscales: weight, physical activity, dietary variety, dietary excess, and household food insecurity. The scores for each question can be added to generate an overall WAVE score that provides a quick estimate of the patient's overall health habits. The WAVE score can range from 0 to 21. The scores are interpreted as follows: 0 to 5= High priority for intervention to improve health habits; 6 to 11=In need of much improvement; 12 to 16=Some good health habits but needs improvement; and 17 to 21=Good to excellent health habits.

    Measured: baseline, week 12, week 24

  15. Drug Use Screening Inventory (DUSI)

    Assesses drug use

    Measured: baseline, week 12, week 24

  16. Stressful Life Events Schedule (SLES)

    The SLES (total score) ascertains 80 adolescent- and parent-reported negative life events, and their impact, during the preceding six months or time since last assessment. Participants responds whether or not an event has occurred and then rate how much the event affected them on a scale of 1 to 4 (1=not at all to 4=a lot).

    Measured: baseline, week 12, week 24

  17. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month time interval. Each question is scored with a total score of "5" or greater indicating poor sleep quality. Items collect time and length of sleep. Other items look at factors affecting sleep and responses range from 0 (not during the past month) to 3 (three or more times a week).

    Measured: baseline, week 12, week 24

  18. Exercise-Induced Feeling Inventory (EIFI)

    The Exercise-Induced Feeling Inventory measures the intensity of 12 feeling states as they occur in relation to physical activity. Responses are rated from 0 (do not feel) to 4 (feel very strongly) for each emotion. The EIFI consists of 12 items that capture 4 distinct feeling states: revitalization, tranquility, positive engagement, and physical exhaustion. The EIFI consists of 4 distinct subscales. Subscale scores are obtained by summing or averaging the numerical values chosen for the adjectives within a particular subscale. The four subscales include: (1) Positive Engagement (items 4, 7, \& 12), (2) Revitalization (items, 1, 6, \& 9), (3) Tranquility (items 2, 5, \& 10), and (4) Physical Exhaustion (items, 3, 8, \& 11).

    Measured: baseline, then pre- and post-aerobic fitness testing at weeks 0, 2, 8, 12, and 24

  19. Physical Activity Logs

    The physical activity logs will be used by participants to record any moderate to vigorous intensity exercise, including details such as the time of day, type of exercise, and thoughts, feelings and physical sensations in regards to the exercise

    Measured: Through study completion, an average of 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start15 Jun 2018
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Why it stopped: The study was terminated due to the COVID-19 pandemic as no in-person study visits were permitted.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562520
Sponsor's protocol ID
007-2018
Acronym
TEAM-BD
Status last verified
Mar 2021
First submitted
23 Apr 2018
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavior change counseling in people with Bipolar Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to the COVID-19 pandemic as no in-person study visits were permitted.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barriers to participation using the Client Satisfaction Questionnaire (time frame: Week 12). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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