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New treatment option for TBI (Traumatic Brain Injury)
Official title InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
ClinicalTrials.gov ID: NCT06005194
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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)).
You likely can't join if
- We will exclude people with active suicidal intent or plan or other severe psychiatric conditions (bipolar disorder, schizophrenia, psychosis, any...
- We will exclude people with current substance use disorder (excluding tobacco) because they require intensive treatment, specifically people who...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.