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InMotion: Telehealth Exercise for Depression After TBI

This study, called InMotion, is testing if a telehealth program that encourages physical activity can help people with major depression (Major Depressive Disorder or MDD) after a traumatic brain injury (TBI). The program, InMotion, uses counseling to help you become more active. Researchers want to see if this program is better at reducing depression symptoms than a waitlist. They will measure your depression symptoms using the Hopkins Symptom Checklist-20 (SCL-20) at the start, after 12 weeks, and again after 24 weeks. You can join if you are between 18 and 64 years old, have had a TBI at least one year ago, and are enrolled in a Traumatic Brain Injury Model System (TBIMS) at one of six specific centers. The study aims to enroll 80 participants, but its current status is unclear.

Study design
This is a randomized controlled trial comparing the InMotion intervention to a waitlist. It plans to include 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured at 12 weeks and 24 weeks after starting the study.

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NCT06005194

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

Recruiting
NAAges 18–64InterventionalTreatment
University of Washington
~80 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:InMotion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hopkins Symptom Checklist-20 (SCL-20)
Measured over Baseline
+2 more outcomes measured

Conditions

TBI (Traumatic Brain Injury)
Depressive Disorder, Major
Clinical Depression
Mood Depressed
Physical Inactivity

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Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Charles Bombardier, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Erica Wasmund
[email protected]
206 897 6322
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Hopkins Symptom Checklist-20 (SCL-20)Baseline

    The HSCL-20 is a 20-item self-report depression scale on which respondents rate depression symptom severity over the past week on a 5-point scale ranging from (0) not at all to (4) extremely. The total score represents the mean of the 20 items. The total score can range from 0 to 4 with higher numbers indicating worse symptoms.

  • Hopkins Symptom Checklist-20 (SCL-20)12 weeks

    The HSCL-20 is a 20-item self-report depression scale on which respondents rate depression symptom severity over the past week on a 5-point scale ranging from (0) not at all to (4) extremely. The total score represents the mean of the 20 items. The total score can range from 0 to 4 with higher numbers indicating worse symptoms. We will be measuring depression severity at 12 weeks controlling for depression severity at baseline.

  • Hopkins Symptom Checklist-20 (SCL-20)24 weeks

    The HSCL-20 is a 20-item self-report depression scale on which respondents rate depression symptom severity over the past week on a 5-point scale ranging from (0) not at all to (4) extremely. The total score represents the mean of the 20 items. The total score can range from 0 to 4 with higher numbers indicating worse symptoms. We will be measuring depression severity at 24 weeks controlling for depression severity at baseline.