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NCT06005194Recruiting

InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
18 May 2023
Start date
14 Nov 2023
Primary completion date
31 Dec 2026
Lead sponsor
University of Washington
Diseases
Depression
NCT number
NCT06005194

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 14 Nov 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • We will exclude people for drug dependence as defined within the Mini International Neuropsychiatric Interview (MINI).
  • 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.

Other illness

  • 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.

Other

  • We will exclude people not fluent in English.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Washington Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.