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Behavioral Activation for Depression in Veterans with Traumatic Brain Injury (ACTIVE Trial)
N/A
Recruiting
Led By Helene Joy Moriarty, PhD RN
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 21 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
ACTIVE Trial Summary
This trial will study the feasibility of using behavioral activation to treat depression in veterans with TBI, and assess its effects on depression symptoms, community reintegration, and quality of life.
Who is the study for?
This trial is for Veterans aged 21 or older with mild to moderate TBI and depression, enrolled in outpatient rehab at the Corporal Michael J. Crescenz VA Medical Center. They must have stable medication use if on antidepressants, speak English, and not be receiving Cognitive Behavioral Therapy for depression or have severe cognitive impairments.Check my eligibility
What is being tested?
The study tests Behavioral Activation (BA), a short treatment aiming to reduce post-TBI depression by setting goals and engaging in activities. Participants will either receive BA plus usual care or just usual care, with outcomes like depressive symptoms and quality of life measured.See study design
What are the potential side effects?
Since this trial involves behavioral therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during sessions.
ACTIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
ACTIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depressive symptom scores on CES-D
Secondary outcome measures
Community reintegration scores on PART-O-17
Quality of life in TBI scores on QoL-TBI instrument
Other outcome measures
Acceptability of the intervention rated by the interventionist
Recruitment
Retention
+2 moreACTIVE Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment as Usual Control GroupExperimental Treatment1 Intervention
Participants in the Control group receive treatment as usual (TAU), which is usual care provided by the VA medical center.
Group II: Behavioral Activation (BA) intervention groupExperimental Treatment2 Interventions
Participants in the BA group will receive BA treatment and treatment as usual. BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in an office at the VA rehabilitation clinic or the home, depending on the veteran's preference.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation
2013
Completed Phase 3
~2980
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,563 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,674 Total Patients Enrolled
Helene Joy Moriarty, PhD RNPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty with speaking or understanding language.I have been on my current mood or behavior medication for at least three months.I have been in psychotherapy for at least three months.I am 21 years old or older.I have been diagnosed with a severe traumatic brain injury.I have been diagnosed with a mild or moderate traumatic brain injury.I am currently undergoing therapy for depression.I have memory issues and scored below 26 on a MoCA test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual Control Group
- Group 2: Behavioral Activation (BA) intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers currently being accepted for this experiment?
"This clinical trial, as reported on clinicaltrials.gov, is currently seeking candidates. The trial was initially posted on 2/15/2022 and was most recently updated on 3/3/2022."
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