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NCT04976621 · ClinicalTrials.gov registry record · NA
ACTIVE: Activity Therapy to Increase Veteran Engagement
A NA study of Traumatic Brain Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04976621 is a NA study of Traumatic Brain Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 46 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04976621, a NA study of Traumatic Brain Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
Depression is common after traumatic brain injury (TBI) and may have wide-ranging consequences. Post-TBI depression may impede reintegration into the family and community and lead to lower quality of life and heightened suicide risk. It may also interfere with rehabilitation. Yet, current treatments for post-TBI depression are based largely on expert opinion rather than evidence from rigorous studies. Behavioral activation (BA) is a promising intervention for post-TBI depression. It is a brief behavioral treatment that helps people define goals, create and execute plans to reach them, and engage in meaningful activities. BA has been tested in clinical trials since the 1970s and has been shown to reduce or prevent depression in populations with diverse medical conditions. However, BA has rarely been used or studied for treatment of depression in a TBI population. The investigators will conduct a study of BA with at least 40 Veterans with TBI and depressive symptoms in VA outpatient rehabilitation care. One group of Veterans will be randomly assigned to receive BA plus usual care. The BA program consists of six sessions delivered over three months at the VA (or Veterans' homes, if preferred) by an occupational therapist (OT). A second group of Veterans will be randomly assigned to receive usual care. The investigators will assess the feasibility of delivering the BA intervention in the rehabilitation setting and its acceptability to Veterans and staff. The research team will also assess participant responses to BA in the outcomes of depressive symptoms, community reintegration, and quality of life. Study findings will be used to guide the development of a future study of BA in a larger sample of Veterans with post-TBI depression. This study and future research may add a powerful clinical tool to rehabilitation services to lessen or prevent depression in Veterans with TBI. Reducing depression may in turn facilitate rehabilitation and enhance community reintegration,
Conditions Studied
Interventions
- OTHER Treatment as Usual
- BEHAVIORAL Behavioral Activation
Study Locations (1)
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2024-06-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04976621
The ClinicalTrials.gov registry entry for NCT04976621 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT04976621 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04976621 about?
NCT04976621 is a clinical study titled "ACTIVE: Activity Therapy to Increase Veteran Engagement". Depression is common after traumatic brain injury (TBI) and may have wide-ranging consequences. Post-TBI depression may impede reintegration into the family and community and lead to lower quality of life and heightened suicide risk. It may also interfere with rehabilitation. Yet, current treatments...
What is the current status of trial NCT04976621?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2022-02-15. Estimated completion is 2024-06-03.
What conditions does trial NCT04976621 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT04976621?
The interventions under investigation include: Treatment as Usual (OTHER), Behavioral Activation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04976621?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04976621 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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