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Life Skills Workshop for Traumatic Brain Injury

N/A
Waitlist Available
Led By Lilian N. Dindo, PhD
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
Stress-based psychopathology, as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD on the M.I.N.I. International Neuropsychiatric interview (M.I.N.I.)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study whether a 1-day "life skills group workshop" can help reduce overall distress and improve reintegration for veterans with mTBI and stress-based psychopathology.

Who is the study for?
This trial is for Veterans who served in Iraq/Afghanistan with moderate pain from mild traumatic brain injury (mTBI), depression, PTSD, or anxiety. They must have a moderate level of distress and be able to participate in a one-day workshop. Those with bipolar disorder, severe substance use, high suicide risk, unrelated neurological illness, or severe medical conditions cannot join.Check my eligibility
What is being tested?
The study tests a one-day 'life skills group workshop' designed to help Veterans cope better with the challenges of mTBI, chronic pain, and stress-related psychopathology like depression and PTSD. It aims to improve overall well-being and social reintegration.See study design
What are the potential side effects?
Since this intervention involves education and support rather than medication or invasive procedures, typical medical side effects are not expected. However, discussing trauma could potentially cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with depression, anxiety, or PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Military to Civilian Questionnaire (M2C-Q)
The Depression Anxiety and Stress Scale (DASS-21)
Secondary outcome measures
Defense and Veterans Pain Rating Scale
The PTSD Checklist for DSM-5 (PCL-5)
Other outcome measures
Acceptance and Action Questionnaire-II
Self-reported service utilization
Valued Living Questionnaire (VLQ)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ACT on LifeActive Control1 Intervention
Acceptance and Commitment Therapy plus Education, Resources and Support ('ACT on Life'). The ACT+ERS intervention will include: 1) Acceptance and Mindfulness Training (2-3 hours); 2) Committed Action Training (2-3 hours) involving helping Veterans clarify what matters most to them and what they want to stand for in life, how they want to behave, and what sorts of strengths and qualities they want to develop; and; 3) Education, Resources, and Support (1 hour).
Group II: Education, Resources, and SupportPlacebo Group1 Intervention
Information provided in the ERS workshop was compiled from existing VHA and community resources. Veterans will be educated about 1) symptoms of depression, anxiety and PTSD and how these conditions do and do not impact daily life and functional ability; 2) common difficulties and challenges with reintegration into civilian life; 3) mild TBI, differences between civilian and Veteran TBIs, shared/crossover symptoms (for example, memory and concentration difficulties, sleep disturbance, irritability can be symptoms of depression, PTSD, and mild TBI); 4) chronic pain; how it is often often misinterpreted as on-going damage, leading to fear of physical activities and resulting in increased sedentary behavior and declines in physical functioning; and 5) treatment options and resources. Basic resource counseling will include guidance on the evidence-based treatments available at VHA. Problem solving, relaxation, and deep breathing techniques will be covered

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,279 Total Patients Enrolled
Lilian N. Dindo, PhDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
2 Previous Clinical Trials
439 Total Patients Enrolled

Media Library

ACT on Life Clinical Trial Eligibility Overview. Trial Name: NCT04143243 — N/A
Traumatic Brain Injury Research Study Groups: Education, Resources, and Support, ACT on Life
Traumatic Brain Injury Clinical Trial 2023: ACT on Life Highlights & Side Effects. Trial Name: NCT04143243 — N/A
ACT on Life 2023 Treatment Timeline for Medical Study. Trial Name: NCT04143243 — N/A

Frequently Asked Questions

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

How closely monitored is the use of ACT on Life for those undergoing treatment?

"ACT on Life received a score of 2, as this is currently classified as a Phase 2 trial. This signifies that there are some data indicating safety but none to suggest efficacy."

Answered by AI

Are there any available spots for potential participants in this clinical trial?

"Indeed, according to clinicaltrials.gov, this research study is currently seeking volunteers after being first posted on July 1st 2020 and last revised on November 7th 2022. The trial necessitates 212 participants at one site of recruitment."

Answered by AI

How many participants are taking part in this experiment?

"Indeed, clinicaltrials.gov data corroborate that this research study is now accepting participants. This trial was initially posted on July 1st 2020 and most recently updated on November 7th 2022, with a total of 212 patients required from just one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~11 spots leftby Aug 2024