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

NCT ID: NCT06005194

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2027-09-30

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.

Detailed Description

Telehealth delivered exercise promotion to treat major depression after traumatic brain injury (TBI): A randomized controlled trial, or InMotion, is a fully-powered, single-blind, randomized controlled trial versus wait-list control (WLC) condition focused on the comparing the InMotion intervention. The intervention is delivered via telehealth and uses evidence-based behavioral and motivational counseling to increase daily physical activity, and is being tested to see whether this can be 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 goal of the study is for all participants to achieve 150 minutes per week of moderate to vigorous physical activity (MVPA), a dose of physical activity already shown to be effective to treat MDD in a healthy population.

The InMotion intervention is a home- and community-based physical activity counseling program based on the widely replicated Diabetes Prevention Program (DPP). The physical activity coach/Interventionist is a mental health provider (Master of Social Work/MSW) who has training and supervision in behavioral aspects of exercise promotion and will use motivational interviewing, telehealth technology using a HIPAA-compliant telehealth delivery model. The intervention also includes the use of a wearable activity monitor (Fitbit activity tracker watch - Charge 5) to facilitate goal setting.

Enrollment into the Traumatic Brain Injury Model System (TBIMS) study is required for eligibility for InMotion. Additionally, this study will capitalize on the infrastructure of the TBIMS for its screening and some data collection.

Specific Aims Aim 1: 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 traumatic brain injury (TBI) and Major Depressive Disorder (MDD).

Hypothesis 1a: There will be a significantly greater reduction in depression severity as measured by the Symptom Checklist-20 (SCL-20) over 12 weeks in the InMotion intervention group vs. the wait-list control (WLC) group.

Hypothesis 1b: Compared to the WLC group, the InMotion intervention group will demonstrate significantly greater improvement on secondary outcome measures: MDD diagnosis (yes/no), depression remission (yes/no), anxiety, pain, fatigue, and quality of life from baseline to 12-weeks.

Hypothesis 1c: Within the InMotion intervention group, the investigators will describe how much/if any improvement on outcomes is maintained from the end of the treatment period (12 weeks) to follow-up (24 weeks).

Rationale for Aim 1: A statistically significant reduction in depression symptom severity is the most common metric for depression treatment efficacy and what will be used to power the study. However, the investigators also want to assess clinically meaningful changes in depression such as depression diagnosis and depression remission. The investigators will study the impact of the intervention on anxiety, pain, fatigue, and quality of life in people with TBI because these are correlated with depression and important outcomes.

Aim 2: To identify possible moderators of exercise treatment effects. Hypothesis 2: Self-identified race (African American vs. not African American), sex (female vs. male), TBI severity (moderate vs. severe), or concurrent exposure to antidepressant or psychotherapy vs. neither will moderate the effect of InMotion intervention on depression severity.

Rationale for Aim 2: Some participant groups may benefit differentially from exercise.

Identifying factors associated with response to treatment will guide future research.

Aim 3: To identify possible mediators of treatment outcome. Investigators will explore weekly dose of exercise, the extent to which exercise generates positive affect, and engagement in enjoyable or meaningful aspects of life.

Hypothesis 3: The InMotion intervention will be indirectly associated with improved outcomes by its association with higher self-reported weekly minutes/week of activity, higher positive affect, and greater involvement in meaningful activities.

Rationale for Aim 3: Analysis of potential mediators of treatment effects can help guide the refinement of the InMotion intervention.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

InMotion

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

InMotion

Intervention Type: BEHAVIORAL

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

Interventions

InMotion

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Charles Bombardier

Professor of Rehabilitation Medicine, University of Washington

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Bombardier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erica Wasmund

Role: CONTACT

ericaw8@uw.edu

206 897 6322

Facility Contacts

Erica Wasmund

Role: primary

ericaw8@uw.edu

Silas James, MPA

Role: backup

silast@uw.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

90DPTB0024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00017569

Identifier Type: -

Identifier Source: org_study_id