Recruiting

InMotion

Sponsor:

University of Washington

Code:

NCT06005194

Conditions

TBI (Traumatic Brain Injury)

Depressive Disorder, Major

Clinical Depression

Mood Depressed

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

InMotion

Study Details

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.

Conditions

TBI (Traumatic Brain Injury)

Depressive Disorder, Major

Clinical Depression

Mood Depressed

Physical Inactivity

Study ID

NCT06005194

Start date

Nov 14, 2023

Status verified date

Sep, 2024

Completion date

Sep, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Wait List Control (WLC) Condition

The WLC control condition entails following usual care and includes the ability to participate in the intervention at the 12 week-end point for the intervention group. The WLC condition is based on equity considerations; the investigators want all participants to have access to treatment. Equity is especially important given our plans to over-enroll African American persons given statistically increased barriers to access care.

active comparator: InMotion Intervention Condition

The intervention consists of a manualized physical activity counseling program and includes motivational interviewing over a HIPAA-compliant telehealth delivery model. There will be 8 counseling sessions over 12 weeks. Sessions will be 30-90 minutes long and scheduled during weeks 1-4, 6, 8, 10, and 12. The Fitbit Charge 5 will be set up to sync with the participants' internet-connected device to share activity data with the physical activity coach /interventionist to monitor progress and tailor treatment goals.

Given the InMotion intervention was designed to treat Major Depressive Disorder (MDD) in Traumatic Brain Injury (TBI), the intervention will be delivered by a mental health provider (licensed masters level social worker/MSW) with training and supervision in behavioral aspects of exercise promotion and supervised by a psychologist (who is also the study Principal Investigator) and a physical therapist.

Interventions

InMotion

A manualized physical activity counseling program that is based on the Diabetes Prevention Program (DPP) that has been adapted for TBI

Primary outcome measure

  • Hopkins Symptom Checklist-20 (SCL-20) [ Time Frame: Baseline ]
  • Hopkins Symptom Checklist-20 (SCL-20) [ Time Frame: 12 weeks ]
  • Hopkins Symptom Checklist-20 (SCL-20) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Erica Wasmund

206 897 6322ericaw8@uw.edu

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98105

Contacts

Erica Wasmund

ericaw8@uw.edu

Silas James, MPA

silast@uw.edu

Principal Investigator:

Charles Bombardier, PhD

More Information

Sponsor

University of Washington

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Exercise Intervention
  • Traumatic Brain Injury (TBI)
  • Motivational Interviewing
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-13. This information was provided to ClinicalTrials.gov by University of Washington on 2024-09-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.