Telehealth Delivered Exercise Promotion for Depression After TBI

Overseen By Erica Wasmund

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

80 Participants Needed

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. ^{1 2 3 4 5}

Is telehealth delivered exercise promotion safe for humans?

Exercise interventions, including those delivered via telehealth, are generally safe for humans. Studies have shown no serious exercise-related adverse events, and participants often find exercise enjoyable and beneficial for mental health conditions. ^{6 7 8 9 10}

How does the InMotion treatment for depression after TBI differ from other treatments?

InMotion is unique because it uses telehealth to deliver exercise programs remotely, allowing people with traumatic brain injury (TBI) to engage in high-intensity exercise from home, which is not a standard approach for treating depression after TBI. ^{3 4 5 11 12}

Research Team

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)

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.

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

Trial Overview The 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

Group I: InMotion Intervention Condition Active Control 1 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) Condition Placebo Group 1 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.

InMotion is already approved in United States for the following indications:

Approved in United States as InMotion for:

• Major Depressive Disorder (MDD) in individuals with Traumatic Brain Injury (TBI)

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

A systematic review of 13 studies, including 7 randomized controlled trials, found that 8 of these studies reported improvements in quality of life (QOL) for individuals with traumatic brain injury (TBI) following exercise interventions lasting 8-12 weeks.

The exercise programs typically involved moderate to vigorous activities, conducted 3-5 times a week for 30-60 minutes, suggesting that regular physical activity may positively influence QOL in TBI patients, although the variability in study designs and outcomes makes it difficult to draw definitive conclusions.

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]

A qualitative study involving eight individuals with severe traumatic brain injury (TBI) revealed that their engagement in physical activity (PA) is significantly influenced by their lifelong habits and current life priorities, which can either motivate or hinder their activity levels.

To effectively promote physical activity among people with TBI, rehabilitation interventions should consider these personal perceptions and adapt activities to fit their life circumstances and the challenges posed by TBI-related impairments.

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]

Home-based telerehabilitation exercise programs using videoconferencing and activity tracking devices were found to be feasible for individuals with moderate to severe traumatic brain injury (TBI), with high adherence and satisfaction reported by participants and their family partners.

The study suggests that telerehabilitation can enhance access to physiotherapy for TBI patients, allowing them to focus on therapy rather than travel, although further research is needed to evaluate its effectiveness on physical outcomes like balance and mobility.

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]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

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]

A 10-week exercise intervention significantly reduced depression scores in individuals with traumatic brain injury (TBI), and these improvements were maintained for at least 6 months after the program ended.

Participants who engaged in more than 90 minutes of exercise per week reported even greater reductions in depression and improvements in quality of life and mental health, highlighting the importance of sustained physical activity in managing depression post-TBI.

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

1. England pubmed.ncbi.nlm.nih.gov

The effects of exercise to promote quality of life in individuals with traumatic brain injuries: a systematic review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Physical activity: perceptions of people with severe traumatic brain injury living in the community. [2019]

3. Canada 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Benefits of exercise maintenance after traumatic brain injury. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]

7. England 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. [2023]

8. United States 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. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Enjoying Sports and Movement in Mental Illness]. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Participatory co-creation of an adapted physical activity program for adults with moderate-to-severe traumatic brain injury. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Feasibility and effect of aerobic exercise for lowering depressive symptoms among individuals with traumatic brain injury: a pilot study. [2012]