Actively Recruiting
InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
Led by University of Washington · Updated on 2024-09-19
80
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 more than 1 year out from the date of the Traumatic Brain Injury.
- Meet the criteria for major depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI).
- Must have a Health Contribution Score of less than 24 on the Godin Leisure Time Exercise Questionnaire.
- Deemed medically safe to exercise based on the Physical Activity Readiness Questionnaire (PAR-Q+), with physician attestation if needed.
- Must have a permanent residence and access to the internet.
- The study aims to enroll 27% of participants who identify as African American due to higher risk and treatment barriers.
You will not qualify if you...
- Presence of active suicidal intent or plan or other severe psychiatric conditions such as bipolar disorder, schizophrenia, psychosis, or schizoaffective disorder.
- Current substance use disorder (excluding tobacco), defined as having more than 5 drinks for men or more than 4 drinks for women on a single occasion AND more than 14 drinks per week for males or more than 7 drinks per week for females.
- Drug dependence as defined by the Mini International Neuropsychiatric Interview (MINI).
- Not fluent in English.
- Pending surgery or unstable dose of standard depression treatment; must be recovered or stable for at least 3 weeks before enrollment.
- Elevated suicide risk will lead to exclusion and referral for treatment; suicide risk is assessed at every outcome point with intervention as needed.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington Medical Center
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
E
Erica Wasmund
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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