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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005194
• Other study ID #: STUDY00017569
• Secondary ID: 90DPTB0024
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: Leslie Kempthorne
• Phone: 206 685 1082
• Email: ette[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Clinical Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Physical Inactivity
• TBI (Traumatic Brain Injury)

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a 9 item measure of depression severity with excellent sensitivity, specificity and responsiveness in people with TBI and will be used for pre-screening as well as each data collection to calculate minimal clinically important differences (MCID). Each item is rated on a 0 (not at all) to 3 (nearly every day) scale. The total score ranges from 0-27. A higher score indicates increased depression severity.	Baseline
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a 9 item measure of depression severity with excellent sensitivity, specificity and responsiveness in people with TBI and will be used for pre-screening as well as each data collection to calculate minimal clinically important differences (MCID). Each item is rated on a 0 (not at all) to 3 (nearly every day) scale. The total score ranges from 0-27. A higher score indicates increased depression severity.	12 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a 9 item measure of depression severity with excellent sensitivity, specificity and responsiveness in people with TBI and will be used for pre-screening as well as each data collection to calculate minimal clinically important differences (MCID). Each item is rated on a 0 (not at all) to 3 (nearly every day) scale. The total score ranges from 0-27. A higher score indicates increased depression severity.	24 weeks
Secondary	Godin Leisure-Time Exercise Questionnaire (GLTEQ)	The GLETQ measures number of bouts per week (0-7) of mild, moderate, or strenuous exercise that last at least 15 minutes.	Baseline
Secondary	Godin Leisure-Time Exercise Questionnaire (GLTEQ)	The GLETQ measures number of bouts per week (0-7) of mild, moderate, or strenuous exercise that last at least 15 minutes.	12 weeks
Secondary	Godin Leisure-Time Exercise	The GLETQ measures number of bouts per week (0-7) of mild, moderate, or strenuous exercise that last at least 15 minutes.	24 weeks
Secondary	Behavioral Risk Factor Surveillance System (BRFSS/2011)	Asks participants about meeting strength training guidelines (2 times per week)	Baseline
Secondary	Behavioral Risk Factor Surveillance System (BRFSS/2011)	Asks participants about meeting strength training guidelines (2 times per week)	12 weeks
Secondary	Behavioral Risk Factor Surveillance System (BRFSS/2011)	Asks participants about meeting strength training guidelines (2 times per week)	24 weeks
Secondary	Brief Pain Inventory (BPI) - Intensity and Interference	We will use the pain intensity and interference scales from the widely used BPI which uses a 0-10 Likert scale for ratings. A higher score indicates increased level of pain.	Baseline
Secondary	Brief Pain Inventory (BPI) - Intensity and Interference	We will use the pain intensity and interference scales from the widely used BPI which uses a 0-10 Likert scale for ratings. A higher score indicates increased level of pain.	12 weeks
Secondary	Brief Pain Inventory (BPI) - Intensity and Interference	We will use the pain intensity and interference scales from the widely used BPI which uses a 0-10 Likert scale for ratings. A higher score indicates increased level of pain.	24 weeks
Secondary	Positive (and Negative) Affect Schedule (PANAS)	The Positive (and Negative) Affect Schedule or (PANAS) is a scale that consists of 10 items with different words that describe feelings and emotion. - Adapted to use positive items only.	Baseline
Secondary	Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only	The Positive (and Negative) Affect Schedule or (PANAS) is a scale that consists of 10 items with different words that describe feelings and emotion. - Adapted to use positive items only.	12 weeks
Secondary	Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only	The Positive (and Negative) Affect Schedule or (PANAS) is a scale that consists of 10 items with different words that describe feelings and emotion. - Adapted to use positive items only.	24 weeks
Secondary	Patient Global Impression of Change (PGIC)	A 3-question scale designed to assess perception of change and improvement. The scale includes their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	12 weeks
Secondary	Patient Global Assessment of Treatment Satisfaction (PGATS)	A 1-question scale designed to assess satisfaction of treatment. It is scored from 0-10 or 0-100, with higher numbers representing worse perceived disease activity or overall health.	12 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a seven-item, self-report anxiety measure designed to assess health status during the previous 2 weeks. A higher score indicates a higher level of anxiety.	Baseline
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a seven-item, self-report anxiety measure designed to assess health status during the previous 2 weeks. A higher score indicates a higher level of anxiety.	12 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a seven-item, self-report anxiety measure designed to assess health status during the previous 2 weeks. A higher score indicates a higher level of anxiety.	24 weeks
Secondary	Quality of Life after Brain Injury Scale (QoLIBRI)	The QoLIBRI is a self-reported measure of satisfaction in areas including: thinking abilities, emotions, independence and social relationships and is a TBI Common Data Element measure. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.	Baseline
Secondary	Quality of Life after Brain Injury Scale (QoLIBRI)	The QoLIBRI is a self-reported measure of satisfaction in areas including: thinking abilities, emotions, independence and social relationships and is a TBI Common Data Element measure. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.	12 weeks
Secondary	Quality of Life after Brain Injury Scale (QoLIBRI)	The QoLIBRI is a self-reported measure of satisfaction in areas including: thinking abilities, emotions, independence and social relationships and is a TBI Common Data Element measure. The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.	24 weeks
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale	The PROMIS 6a scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days.	Baseline
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale	The PROMIS 6a scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days.	12 weeks
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale	The PROMIS 6a scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days.	24 weeks
Secondary	Behavioral Activation for Depression Scale (BADS)	The BADS measure was developed to measure behavioral activation over the course of treatment. For all subscales, high scores are consistent with the subscale title.	Baseline
Secondary	Behavioral Activation for Depression Scale (BADS)	The BADS measure was developed to measure behavioral activation over the course of treatment. For all subscales, high scores are consistent with the subscale title.	12 weeks
Secondary	Behavioral Activation for Depression Scale (BADS)	The BADS measure was developed to measure behavioral activation over the course of treatment. For all subscales, high scores are consistent with the subscale title.	24 weeks
Secondary	Minutes per week of Moderate to Vigorous Physical Activity (MVPA)	We will use the Fitbit Charge 5 device settings and activity count cutoffs to measure moderate to vigorous physical activity (MVPA).	Baseline
Secondary	Minutes per week of Moderate to Vigorous Physical Activity (MVPA)	We will use the Fitbit Charge 5 device settings and activity count cutoffs to measure moderate to vigorous physical activity (MVPA).	12 weeks
Secondary	Minutes per week of Moderate to Vigorous Physical Activity (MVPA)	We will use the Fitbit Charge 5 device settings and activity count cutoffs to measure moderate to vigorous physical activity (MVPA).	24 weeks