RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The intervention also includes the use of a wearable activity monitor (Fitbit activity tracker watch - Charge 5) to facilitate goal setting."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether counseling by video or phone to help people be more active can treat major depression. It is for adults ages 18–64 who are not very active and had a traumatic brain injury (TBI) more than a year ago. The study compares people who get counseling with people on a waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be enrolled in the Traumatic Brain Injury Model System at one of the six referring centers.
  • Be 18–64 years old and able to understand and agree to join the study.
  • Have had a traumatic brain injury—brain damage caused by an injury—more than one year ago.
  • Have major depression, as shown by a mental health interview.
  • Have a score below 24 on the Godin exercise survey, showing a low level of physical activity.
  • Be safe to exercise based on a health checklist. Some answers require a doctor's approval.
  • Have a permanent home and internet access.
  • The study plans for 27% of participants to identify as African American.

Who can't join

  • Have an intent or plan to end your life. The study will refer you for treatment right away.
  • Have bipolar disorder, schizophrenia, psychosis, or schizoaffective disorder—serious conditions that affect mood or how you understand reality.
  • Have a current substance use disorder, not counting tobacco. Alcohol limits listed are more than 5 drinks at once AND more than 14 per week for men, or more than 4 at once AND more than 7 per week for women.
  • Have drug dependence, as shown by a mental health interview.
  • Not be fluent in English.
  • Have surgery coming up or a changing dose of depression treatment. You must wait until you have recovered or your treatment has been stable for at least 3 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

WA