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

NCT06005194 | Recruiting DMC

• 2 other identifiers: STUDY0001756990DPTB0024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Hopkins Symptom Checklist-20 (SCL-20)

  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.

  Baseline

• Hopkins Symptom Checklist-20 (SCL-20)

  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.

  12 weeks

• Hopkins Symptom Checklist-20 (SCL-20)

  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.

  24 weeks

Secondary Outcomes (32)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline

• Patient Health Questionnaire-9 (PHQ-9)

  12 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  24 weeks

• Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  Baseline

• Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  12 weeks

Study Arms (2)

Wait List Control (WLC) Condition

PLACEBO COMPARATOR

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.

Behavioral: InMotion

InMotion Intervention Condition

ACTIVE COMPARATOR

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.

Behavioral: InMotion

Interventions

InMotion 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; Wait List Control (WLC) Condition

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depressive Disorder, Major; Consciousness Disorders; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Behavior

Study Officials

• Charles Bombardier, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Wasmund

CONTACT

206 897 6322; ericaw8@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation Medicine, University of Washington

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: August 22, 2023
• Study Start: November 14, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Scientific data will be made available to the public no later than 24 months after award end date of 08/31/2027.
• Access Criteria: Administration of Community Living (ACL) (National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)) designates the Interuniversity Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan that provides data archiving services, as its preferred data repository for scientific data from all ACL/NIDILRR-funded research. The exception to this designation is the archiving of longitudinal scientific data collected through the ACL/NIDILRR-funded Burn Injury, Spinal Cord Injury, and Traumatic Brain Injury Model Systems. For these three specific funding programs, the longitudinal scientific data have been and will continue to be deposited to and made publicly available by the National Statistical and Data Center of each respective model system. The National Statistical and Data Centers have the capacity to function as a data repository and making those data accessible to the public.

Locations

US (1)