Telehealth Delivered Exercise Promotion for Depression After TBI
Recruiting in Palo Alto (17 mi)
CB
Overseen byCharles Bombardier, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Bipolar, Schizophrenia, Substance use, others
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this randomized controlled trial is to evaluate whether the InMotion intervention, delivered via telehealth (using a HIPAA-compliant video platform or phone), which uses evidence-based behavioral and motivational counseling to increase daily physical activity, is an effective treatment for Major Depressive Disorder (MDD) for people who are at least one year out from sustaining a traumatic brain injury (TBI). The first aim is to compare the efficacy of the InMotion intervention to the waitlist control (WLC) condition on measures of depression severity and associated conditions in under-active adults with TBI and MDD. For the second aim the investigators plan to identify possible moderators of exercise treatment effects. The third aim will examine possible mediators of treatment outcome. In addition, the weekly dose of exercise, the extent to which exercise generates positive affect, and engagement in enjoyable or meaningful aspects of life will be explored.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on an unstable dose of standard depression treatment, you will need to be on a stable regimen for at least 3 weeks before participating.
What data supports the effectiveness of the treatment InMotion, Telehealth Delivered Exercise Promotion, Exercise-Based Treatment for Major Depression after TBI?
Research shows that exercise programs, including those delivered via telehealth, can improve mood and mental health in people with traumatic brain injury (TBI). Studies have found that exercise can lead to small improvements in depression and anxiety symptoms, suggesting that similar exercise-based treatments may help with depression after TBI.12345
Is telehealth delivered exercise promotion safe for humans?
How does the InMotion treatment for depression after TBI differ from other treatments?
Research Team
CB
Charles Bombardier, PhD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for adults aged 18-64 who have had a traumatic brain injury (TBI) over a year ago, are diagnosed with Major Depressive Disorder, lead a sedentary lifestyle, and are medically cleared to exercise. They must be able to consent, have internet access at home, and not be drug-dependent or planning surgery.Inclusion Criteria
Over-enrollment of people who identify as African American to address higher risk of depression and barriers to treatment
Enrollment in the Traumatic Brain Injury Model System (TBIMS) from one of the six referring centers
Deemed medically safe to exercise (based on the Physical Activity Readiness Questionnaire (PAR-Q+) modified; if a yes response to any question, physician attestation required)
See 6 more
Exclusion Criteria
I am awaiting surgery or my depression medication dose is changing.
Drug dependence as defined within the Mini International Neuropsychiatric Interview (MINI)
I do not have severe psychiatric conditions or active suicidal thoughts.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the InMotion intervention, a telehealth-delivered exercise promotion program, for 12 weeks
12 weeks
8 counseling sessions (telehealth)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Treatment Details
Interventions
- InMotion (Behavioural Intervention)
Trial OverviewThe InMotion program aims to treat depression in people with TBI through motivational counseling and physical activity via telehealth. Participants will either receive the intervention immediately or be placed on a waitlist control group to compare outcomes.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: InMotion Intervention ConditionActive Control1 Intervention
The intervention consists of a manualized physical activity counseling program and includes motivational interviewing over a HIPAA-compliant telehealth delivery model. There will be 8 counseling sessions over 12 weeks. Sessions will be 30-90 minutes long and scheduled during weeks 1-4, 6, 8, 10, and 12. The Fitbit Charge 5 will be set up to sync with the participants' internet-connected device to share activity data with the physical activity coach /interventionist to monitor progress and tailor treatment goals.
Given the InMotion intervention was designed to treat Major Depressive Disorder (MDD) in Traumatic Brain Injury (TBI), the intervention will be delivered by a mental health provider (licensed masters level social worker/MSW) with training and supervision in behavioral aspects of exercise promotion and supervised by a psychologist (who is also the study Principal Investigator) and a physical therapist.
Group II: Wait List Control (WLC) ConditionPlacebo Group1 Intervention
The WLC control condition entails following usual care and includes the ability to participate in the intervention at the 12 week-end point for the intervention group. The WLC condition is based on equity considerations; the investigators want all participants to have access to treatment. Equity is especially important given our plans to over-enroll African American persons given statistically increased barriers to access care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Washington Medical CenterSeattle, WA
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Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Trials
1858
Patients Recruited
2,023,000+
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Trials
83
Patients Recruited
10,500+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The effects of exercise to promote quality of life in individuals with traumatic brain injuries: a systematic review.O'Carroll, GC., King, SL., Carroll, S., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Physical activity: perceptions of people with severe traumatic brain injury living in the community.Analytis, P., McKay, A., Hamilton, M., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Remotely Supervised Exercise Programmes to Improve Balance, Mobility, and Activity Among People with Moderate to Severe Traumatic Brain Injury: Description and Feasibility.O'Neil, J., Egan, M., Marshall, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury.Ding, K., Tarumi, T., Tomoto, T., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Benefits of exercise maintenance after traumatic brain injury.Wise, EK., Hoffman, JM., Powell, JM., et al.[2012]
A pilot trial involving 54 veterans aged 60 and older with PTSD showed that supervised exercise training is safe and well-accepted, with high adherence rates of 82% and minimal attrition of 14%.
Participants experienced clinically significant improvements in PTSD symptoms and related conditions after 12 weeks of exercise, suggesting that exercise could be an effective intervention for older adults with PTSD.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pilot randomized controlled trial of exercise training for older veterans with PTSD.Hall, KS., Morey, MC., Bosworth, HB., et al.[2021]
Exercise interventions in inpatient mental health settings significantly improved depression symptoms, with a moderate effect size (Standardized mean difference = -0.416) across 15 studies, indicating their potential therapeutic benefits.
No serious adverse events were reported from exercise, and most participants found the interventions enjoyable, with over 80% attendance; however, only five trials provided post-discharge support for continued exercise, highlighting a need for better systems to maintain engagement after leaving the hospital.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The efficacy of exercise interventions for all types of inpatients across mental health settings: A systematic review and meta-analysis of 47 studies.Martland, R., Korman, N., Firth, J., et al.[2023]
A study involving 152 patients with serious mental illness showed that focusing on immediate mood benefits from exercise led to significant increases in exercise participation compared to standard fitness-focused interventions.
The exercise-for-mood intervention was particularly effective for patients who were already exercising regularly before joining the program, suggesting that emphasizing short-term emotional gains can be a powerful strategy for promoting physical activity in this population.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Attending to Timely Contingencies: Promoting Physical Activity Uptake Among Adults with Serious Mental Illness with an Exercise-For-Mood vs. an Exercise-For-Fitness Prescription.Hearon, BA., Beard, C., Kopeski, LM., et al.[2022]
Exercise interventions have shown positive health outcomes for hospitalized patients with depression, based on a systematic review of eight studies, indicating that exercise can be beneficial in acute mental health settings.
However, the evidence for the effectiveness of exercise in hospitalized patients with schizophrenia, bipolar disorder, or anxiety disorders is limited, highlighting a need for more research to determine the best exercise approaches for these populations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Exercise for mental illness: a systematic review of inpatient studies.Stanton, R., Happell, B.[2018]
Engaging in sports and exercise therapy can significantly enhance the treatment of major depression, highlighting its effectiveness as a complementary approach.
To achieve positive effects, individuals should aim for at least 150 minutes of moderate or 75 minutes of intense physical activity each week, while also considering personal health needs to ensure long-term enjoyment of exercise.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Enjoying Sports and Movement in Mental Illness].Kreppke, JN., Cody, R., Faude, O., et al.[2022]
The TBI-Health program, developed through a co-creation process with individuals who have moderate-to-severe traumatic brain injury, effectively enhances participation in physical activity by addressing barriers and promoting autonomy.
Participants reported significant physical, psychological, and social benefits from the program, indicating its potential to improve quality of life for adults with TBI, although further research with larger samples is necessary.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Participatory co-creation of an adapted physical activity program for adults with moderate-to-severe traumatic brain injury.Quilico, E., Wilkinson, S., Duncan, L., et al.[2022]
A 12-week aerobic exercise program significantly reduced symptoms of depression and improved self-esteem among four participants with traumatic brain injury, demonstrating its feasibility and effectiveness.
Participants also showed enhanced aerobic capacity with no reported adverse effects, indicating that aerobic exercise can be a safe intervention for improving mental health in this population.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Feasibility and effect of aerobic exercise for lowering depressive symptoms among individuals with traumatic brain injury: a pilot study.Schwandt, M., Harris, JE., Thomas, S., et al.[2012]
References
The effects of exercise to promote quality of life in individuals with traumatic brain injuries: a systematic review. [2021]
Physical activity: perceptions of people with severe traumatic brain injury living in the community. [2019]
Remotely Supervised Exercise Programmes to Improve Balance, Mobility, and Activity Among People with Moderate to Severe Traumatic Brain Injury: Description and Feasibility. [2023]
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]
Benefits of exercise maintenance after traumatic brain injury. [2012]
Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]
The efficacy of exercise interventions for all types of inpatients across mental health settings: A systematic review and meta-analysis of 47 studies. [2023]
Attending to Timely Contingencies: Promoting Physical Activity Uptake Among Adults with Serious Mental Illness with an Exercise-For-Mood vs. an Exercise-For-Fitness Prescription. [2022]
Exercise for mental illness: a systematic review of inpatient studies. [2018]
[Enjoying Sports and Movement in Mental Illness]. [2022]
Participatory co-creation of an adapted physical activity program for adults with moderate-to-severe traumatic brain injury. [2022]
Feasibility and effect of aerobic exercise for lowering depressive symptoms among individuals with traumatic brain injury: a pilot study. [2012]