Telehealth Delivered Exercise Promotion to Treat Major Depression After TBI: A Randomized Controlled Trial (InMotion)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hopkins Symptom Checklist-20 (SCL-20)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hopkins Symptom Checklist-20 (SCL-20)
时间窗: 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.
次要结局
- Godin Leisure-Time Exercise(24 weeks)
- Quality of Life after Brain Injury Scale (QoLIBRI)(24 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) 6 Item Fatigue Scale(24 weeks)
- Positive (and Negative) Affect Schedule (PANAS) - Adapted to use positive items only(24 weeks)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)(12 weeks)
- Behavioral Risk Factor Surveillance System (BRFSS/2011)(24 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(24 weeks)
- Behavioral Activation for Depression Scale (BADS)(24 weeks)
- Minutes per week of Moderate to Vigorous Physical Activity (MVPA)(24 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(24 weeks)
- Brief Pain Inventory (BPI) - Intensity and Interference(24 weeks)
- Positive (and Negative) Affect Schedule (PANAS)(Baseline)
- Patient Global Assessment of Treatment Satisfaction (PGATS)(12 weeks)
- Patient Global Impression of Change (PGIC)(12 weeks)
研究者
Charles Bombardier
Professor of Rehabilitation Medicine, University of Washington
University of Washington