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Behavioural Intervention

Telehealth Delivered Exercise Promotion for Depression After TBI

N/A

Recruiting

Led By Charles Bombardier, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial evaluates whether an online intervention, using evidence-based counseling, can help people with MDD and TBI increase physical activity and improve depression.

Who is the study for?

This trial is for adults aged 18-64 who have had a traumatic brain injury (TBI) over a year ago, are diagnosed with Major Depressive Disorder, lead a sedentary lifestyle, and are medically cleared to exercise. They must be able to consent, have internet access at home, and not be drug-dependent or planning surgery.Check my eligibility

What is being tested?

The InMotion program aims to treat depression in people with TBI through motivational counseling and physical activity via telehealth. Participants will either receive the intervention immediately or be placed on a waitlist control group to compare outcomes.See study design

What are the potential side effects?

Since InMotion promotes exercise through counseling without medication or invasive procedures, side effects may include typical exercise-related issues such as muscle soreness or strain but should generally be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hopkins Symptom Checklist-20 (SCL-20)

Secondary outcome measures

Behavioral Activation for Depression Scale (BADS)

Behavioral Risk Factor Surveillance System (BRFSS/2011)

Brief Pain Inventory (BPI) - Intensity and Interference

+11 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: InMotion Intervention ConditionActive Control1 Intervention

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.

Group II: Wait List Control (WLC) ConditionPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,680 Total Patients Enrolled

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,049 Total Patients Enrolled

Charles Bombardier, PhDPrincipal InvestigatorUniversity of Washington

3 Previous Clinical Trials

420 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for the trial limited to individuals under 40 years of age?

"The age requirements for participation in this study are 18 and 64, respectively."

Answered by AI

Can individuals currently join this experimental program?

"The clinical trial portal shows that this particular trial, initially posted on August 15th 2023 and last updated two days later, is no longer recruiting candidates. Despite this development, there are 1,774 other medical studies presently looking for participants."

Answered by AI

Am I qualified to join this research initiative?

"This study requires that participants have major depressive disorder and be between 18-64 years of age. Around 80 enrollees are needed for this trial."

Answered by AI