RECRUITING

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

Conditions

TBI (Traumatic Brain Injury)Depressive Disorder, Major Clinical Depression Mood Depressed Physical Inactivity Exercise Intervention Traumatic Brain Injury (TBI)Motivational Interviewing Telehealth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)

Quick Facts

Study Start:2023-11-14

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06005194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Erica Wasmund

CONTACT

206 897 6322

ericaw8@uw.edu

Principal Investigator

Charles Bombardier, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington Medical Center

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: University of Washington

Charles Bombardier, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-14

Study Completion Date2027-09

Study Record Updates

Study Start Date2023-11-14

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Exercise Intervention
Traumatic Brain Injury (TBI)
Motivational Interviewing
Telehealth

Additional Relevant MeSH Terms

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