Telehealth exercise program to treat depression after brain injury

Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)

This study tests whether a telehealth exercise program can help people with depression after a brain injury feel better by encouraging them to be more active.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06005194 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial evaluates the InMotion intervention, which promotes physical activity through telehealth to treat Major Depressive Disorder in individuals at least one year post-traumatic brain injury. Participants will receive evidence-based behavioral and motivational counseling aimed at achieving 150 minutes of moderate to vigorous physical activity weekly. The study compares the efficacy of this intervention against a waitlist control group, while also exploring factors that may influence treatment outcomes. The program includes the use of a wearable activity monitor to assist with goal setting and engagement.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 who are at least one year post-TBI and meet criteria for Major Depressive Disorder.

Not a fit: Patients who are not cognitively capable of consenting or those who do not have access to the internet may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide an effective treatment option for individuals suffering from depression following a traumatic brain injury.

How similar studies have performed: Other studies have shown success with similar telehealth and exercise interventions for depression, indicating potential for this approach.

Eligibility criteria

Inclusion Criteria:

* Enrollment in the Traumatic Brain Injury Model System (TBIMS) from one of the six referring centers.
* Must be between 18-64 years of age at the time of enrollment.
* Must have cognitive capacity to consent.
* Must be \>1 year out from the date of the Traumatic Brain Injury.
* Meet the -5 criteria for major depressive disorder (as determined by the Mini International Neuropsychiatric Interview (MINI)).
* Must receive a Health Contribution Score (HCS) of \<24 on the Godin Leisure Time Exercise Questionnaire.
* 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).
* Must have a permanent residence and have access to the internet.
* We will over-enroll people who identify as African American because they are at higher risk of depression and face disproportionate barriers to treatment relative to whites. We chose to over-sample African Americans rather other racial or ethnic groups because they represent the second largest racialized subgroup within the full Traumatic Brain Injury Model Systems (18%) and 27% of those with Major Depressive Disorder (MDD). Therefore, we will enroll a sample that is 27% people who identify as African American.

Exclusion Criteria:

* We will exclude people with active suicidal intent or plan or other severe psychiatric conditions (bipolar disorder, schizophrenia, psychosis, any schizoaffective disorder).
* We will exclude people with current substance use disorder (excluding tobacco) because they require intensive treatment, specifically people who report having \> 5 drinks for men or \>4 for women on a single occasion AND have \>14 drinks for males / \> 7 drinks per week for females per week. These questions are an existing part of the Traumatic Brain Injury Model System, Form II follow-up interview and participant exclusion for this will take place as part of that study.
* We will exclude people for drug dependence as defined within the Mini International Neuropsychiatric Interview (MINI).
* We will exclude people not fluent in English.
* People with pending surgery or on an unstable dose of standard depression treatment will be deferred until they are recovered or on stable treatment regimens for at least 3 weeks.
* To ensure safety in the trial we will exclude people who have suicide intent or plan and immediately refer them for treatment. We will measure suicide risk at every outcome assessment point and address elevated risk via established assessment and intervention protocols.

Where this trial is running

Seattle, Washington

• University of Washington Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Charles Bombardier, PhD — University of Washington
• Study coordinator: Erica Wasmund

Conditions TBI; Depressive Disorder, Major; Clinical Depression; Mood Depressed; Physical Inactivity; Exercise Intervention; Traumatic Brain Injury; Motivational Interviewing