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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth program called InMotion, designed to help individuals with depression after a traumatic brain injury (TBI) become more physically active. The goal is to determine if increasing daily exercise can reduce depression symptoms compared to those waiting to start the program. It suits individuals who experienced a TBI over a year ago, have major depression, and are not very active. Participants must have internet access and be medically cleared to exercise. The research also seeks to identify factors that might influence the effectiveness of this exercise program. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can improve mental health after TBI.

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 prior data suggests that the InMotion intervention is safe for individuals with TBI and MDD?

Research shows that exercise programs, including those offered through telehealth, are generally safe and can boost mood and mental health in people with traumatic brain injury (TBI). The InMotion program uses telehealth to encourage physical activity.

Although specific safety data for the InMotion program is unavailable, exercise programs are usually well-tolerated. Participants will have counseling sessions to motivate them to be active, which is generally a low-risk approach. The trial phase is labeled "Not Applicable," indicating the program is considered safe enough for wide testing without detailed safety studies beforehand.

In a similar telehealth study, improvements in mood and quality of life were observed, with no major negative effects reported. This suggests that the InMotion program might also be safe for participants, helping to reduce depression symptoms without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the InMotion intervention because it offers a novel approach to treating depression after a traumatic brain injury (TBI). Unlike traditional methods that rely heavily on medications or in-person therapy sessions, InMotion uses a telehealth platform to deliver motivational interviewing and a structured exercise program. This approach makes treatment accessible and flexible, allowing participants to engage from home. Additionally, the integration of wearable technology like the Fitbit Charge 5 allows for personalized feedback and progress tracking, potentially enhancing motivation and effectiveness. This innovative blend of technology and therapy could open up new avenues for managing depression in TBI patients, especially for those facing barriers to traditional care.

What evidence suggests that the InMotion intervention is an effective treatment for depression after TBI?

Research has shown that exercise can help reduce symptoms of depression. A previous study found that a 10-week exercise program significantly lowered depression levels in people with traumatic brain injury (TBI). In this trial, the InMotion program, which uses telehealth to provide motivational support and encourage physical activity, is being tested. This method relies on evidence that increased daily activity can improve mood. Early results suggest that telehealth exercise programs are both practical and effective in managing depression after TBI. Participants in this trial will either receive the InMotion intervention or join a Wait List Control (WLC) condition, with the opportunity to participate in the intervention after 12 weeks. ^{1 2 3 4 6}

Who Is on the Research Team?

Charles Bombardier, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

Enrollment in the Traumatic Brain Injury Model System (TBIMS) from one of the six referring centers

It has been over a year since my traumatic brain injury.

Must receive a Health Contribution Score (HCS) of <24 on the Godin Leisure Time Exercise Questionnaire

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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 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]

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 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]

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]

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]

Citations

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The Traumatic Brain Injury Model Systems 1. • Telehealth delivered exercise promotion to treat major depression after TBI: A randomized controlled trial. Assessment and. Prediction of. Outcomes (n=7).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06005194

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Telehealth Delivered Exercise Promotion to Treat Major ... The first aim is to compare the efficacy of the InMotion intervention to the waitlist control (WLC) condition on measures of depression severity ...

4. withpower.com withpower.com/trial/telehealth-delivered-exercise-promotion-for-depression-after-tbi-1c2a1

Telehealth Delivered Exercise Promotion for Depression ... A 10-week exercise intervention significantly reduced depression scores in individuals with traumatic brain injury (TBI), and these improvements were ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8193501/

Pilot Study of Telehealth Delivered Rehabilitative Exercise ... This study provides evidence for the feasibility and acceptability of a telehealth delivered rehabilitative exercise intervention for youth with concussion.

6. msktc.org msktc.org/tbi/model-system-centers/university-washington-traumatic-brain-injury-model-system

University of Washington Traumatic Brain Injury Model ... Telehealth delivered exercise promotion to treat major depression after TBI: A randomized controlled trial, Modular (Joint), 09/01/2022, 08/31/2027. BeHealthy ...