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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06005194
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 14, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Hopkins Symptom Checklist-20 (SCL-20) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical CenterSeattleWashington98105
Erica Wasmund
[email protected]
Silas James, MPA
[email protected]
Charles Bombardier, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Washington Medical Center· Seattle, WA

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