Clinical trial NCT06005194: InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
Official title: Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Depressive Disorder, Major
Clinical Depression
Mood Depressed
Physical Inactivity
Keywords: Exercise Intervention
Traumatic Brain Injury (TBI)
Motivational Interviewing
Telehealth
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2023-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hopkins Symptom Checklist-20 (SCL-20)
timeFrame: Baseline
measure: Hopkins Symptom Checklist-20 (SCL-20)
timeFrame: 12 weeks
measure: Hopkins Symptom Checklist-20 (SCL-20)
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 24 weeks
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: 12 weeks
measure: Godin Leisure-Time Exercise
timeFrame: 24 weeks
measure: Behavioral Risk Factor Surveillance System (BRFSS/2011)
timeFrame: Baseline
measure: Behavioral Risk Factor Surveillance System (BRFSS/2011)
timeFrame: 12 weeks
measure: Behavioral Risk Factor Surveillance System (BRFSS/2011)
timeFrame: 24 weeks
measure: Brief Pain Inventory (BPI) - Intensity and Interference
timeFrame: Baseline
measure: Brief Pain Inventory (BPI) - Intensity and Interference
timeFrame: 12 weeks
measure: Brief Pain Inventory (BPI) - Intensity and Interference
timeFrame: 24 weeks
measure: Positive (and Negative) Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only
timeFrame: 12 weeks
measure: Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only
timeFrame: 24 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 12 weeks
measure: Patient Global Assessment of Treatment Satisfaction (PGATS)
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 24 weeks
measure: Quality of Life after Brain Injury Scale (QoLIBRI)
timeFrame: Baseline
measure: Quality of Life after Brain Injury Scale (QoLIBRI)
timeFrame: 12 weeks
measure: Quality of Life after Brain Injury Scale (QoLIBRI)
timeFrame: 24 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
timeFrame: Baseline
measure: Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
timeFrame: 12 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
timeFrame: 24 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: Baseline
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: 12 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: 24 weeks
measure: Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline
measure: Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 12 weeks
measure: Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Charles Bombardier, PhD
role: PRINCIPAL_INVESTIGATOR
References: