NCT06005194 InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
| NCT ID | NCT06005194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
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.
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 r