Telehealth exercise program to treat depression after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Washington Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Charles Bombardier, PhD — University of Washington
• Study coordinator: Erica Wasmund
• Email: ericaw8@uw.edu
• Phone: 206 897 6322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.