TBI (Traumatic Brain Injury)NCT06005194
InMotion - Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI
A study testing InMotion in people with TBI (Traumatic Brain Injury) and Depressive Disorder, Major, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Depressive Disorder, Major, Clinical Depression
- What is being tested?
- InMotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98105
Erica Wasmund, ericaw8@uw.edu
Silas James, MPA, silast@uw.edu
About this study
Official title: Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)
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.
Read the 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
- Being tested
- InMotion
- Keywords
- Exercise Intervention, Traumatic Brain Injury (TBI), Motivational Interviewing, Telehealth
- Medical subject headings
- Brain Injuries, Traumatic, Depressive Disorder, Major, Consciousness Disorders, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InMotionBehavioural
A manualized physical activity counseling program that is based on the Diabetes Prevention Program (DPP) that has been adapted for TBI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: InMotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (32)
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Asks participants about meeting strength training guidelines (2 times per week)
Measured: Baseline
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Asks participants about meeting strength training guidelines (2 times per week)
Measured: 12 weeks
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Asks participants about meeting strength training guidelines (2 times per week)
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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."
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
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.
Measured: 12 weeks
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.
Measured: 24 weeks
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).
Measured: Baseline
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).
Measured: 12 weeks
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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start14 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Charles Bombardier, University of Washington
- Investigators
- Charles Bombardier, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005194
- Sponsor's protocol ID
- STUDY00017569
- Other IDs
- 90DPTB0024
- Status last verified
- Sep 2024
- First submitted
- 18 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the cycle prospectively collected study data for our module study will be completely de-identified and submitted to Inter-university Consortium for Political and Social Research (ICPSR). We intend to request that study data be embargoed for two years after the conclusion of the study(s) to allow enough time for study investigators to complete and disseminate the study aims. After that time, the data will be available publicly via ICPSR. The project will be assigned a DocID which will allow for persistent identification of the data and the project as a whole. chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://acl.gov/sites/default/files/about-acl/2017-12/ACLPublicAcccessPlan.pdf
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)
- ClinicalTrials.gov ID
- NCT06005194
- Acronym / sponsor ID
- STUDY00017569
- Conditions
- TBI (Traumatic Brain Injury), Depressive Disorder, Major, Clinical Depression, Mood Depressed, Physical Inactivity
- Keywords
- Exercise Intervention, Traumatic Brain Injury (TBI), Motivational Interviewing, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait List Control (WLC) Condition | Placebo comparator | Behavioral: InMotionThe 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. |
| InMotion Intervention Condition | Active comparator | Behavioral: InMotionThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InMotionA manualized physical activity counseling program that is based on the Diabetes Prevention Program (DPP) that has been adapted for TBI | Behavioural | InMotion Intervention Condition, Wait List Control (WLC) Condition |
Primary outcome
Hopkins Symptom Checklist-20 (SCL-20)
Time frame: Baseline
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.
Hopkins Symptom Checklist-20 (SCL-20)
Time frame: 12 weeks
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.
Hopkins Symptom Checklist-20 (SCL-20)
Time frame: 24 weeks
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.
32 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 24 weeks
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: 12 weeks
Godin Leisure-Time Exercise
Time frame: 24 weeks
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Time frame: Baseline
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Time frame: 12 weeks
Behavioral Risk Factor Surveillance System (BRFSS/2011)
Time frame: 24 weeks
Brief Pain Inventory (BPI) - Intensity and Interference
Time frame: Baseline
Brief Pain Inventory (BPI) - Intensity and Interference
Time frame: 12 weeks
Brief Pain Inventory (BPI) - Intensity and Interference
Time frame: 24 weeks
Positive (and Negative) Affect Schedule (PANAS)
Time frame: Baseline
Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only
Time frame: 12 weeks
Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only
Time frame: 24 weeks
Patient Global Impression of Change (PGIC)
Time frame: 12 weeks
Patient Global Assessment of Treatment Satisfaction (PGATS)
Time frame: 12 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 12 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 24 weeks
Quality of Life after Brain Injury Scale (QoLIBRI)
Time frame: Baseline
Quality of Life after Brain Injury Scale (QoLIBRI)
Time frame: 12 weeks
Quality of Life after Brain Injury Scale (QoLIBRI)
Time frame: 24 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
Time frame: Baseline
Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
Time frame: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale
Time frame: 24 weeks
Behavioral Activation for Depression Scale (BADS)
Time frame: Baseline
Behavioral Activation for Depression Scale (BADS)
Time frame: 12 weeks
Behavioral Activation for Depression Scale (BADS)
Time frame: 24 weeks
Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
Time frame: Baseline
Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
Time frame: 12 weeks
Minutes per week of Moderate to Vigorous Physical Activity (MVPA)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. At the conclusion of the cycle prospectively collected study data for our module study will be completely de-identified and submitted to Inter-university Consortium for Political and Social Research (ICPSR). We intend to request that study data be embargoed for two years after the conclusion of the study(s) to allow enough time for study investigators to complete and disseminate the study aims. After that time, the data will be available publicly via ICPSR. The project will be assigned a DocID which will allow for persistent identification of the data and the project as a whole. chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://acl.gov/sites/default/files/about-acl/2017-12/ACLPublicAcccessPlan.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Bombardier, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InMotion in people with TBI (Traumatic Brain Injury) and Depressive Disorder, Major, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Wasmund (206 897 6322, ericaw8@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Symptom Checklist-20 (SCL-20) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.