One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change

NCT04143243 | Completed Results

• 1 other identifier: D3117-R
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.

Conditions

Traumatic Brain Injury; Chronic Pain; Post Traumatic Stress Disorder; Depression; Anxiety

Keywords

Acceptance and Commitment Therapy; Veterans; polytrauma; traumatic brain injury; chronic pain; Post Traumatic Stress Disorder; depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score

  The Depression Anxiety and Stress Scale (DASS-21) measure consists of 21 items that measure current symptoms of depression, anxiety, and stress with a total score. It has been used extensively in clinical trials, including those with military populations. Participants are asked to rate the extent to which they have experienced each state over the past week with a 4-point scale (from 0 = did not apply to me at all to 3 = applied to me very much). For total score, scores are summed and range from 0 to 63. Higher total scores indicate more severe symptoms of depression, anxiety and stress.

  Through study completion, an average of 6 months following workshop/intervention attendance.

• Military to Civilian Questionnaire (M2C-Q)

  The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report measure used to assess the difficulty veterans experience during the post-deployment reintegration process. A total score is calculated by dividing the sum of the item scores by the number of items the veteran completed (excluding those marked "Does not apply").The Minimum possible score is 0 (if all items are answered as "no difficulty" or "does not apply"). Maximum possible score is 4 (if all items are answered as "extreme difficulty"). Higher scores on the M2CQ indicate greater difficulty with reintegration into civilian life.

  Through study completion, an average of 6 months following workshop/intervention attendance.

Secondary Outcomes (2)

• The PTSD Checklist for DSM-5 (PCL-5)

  Through study completion, an average of 6 months following workshop/intervention attendance.

• Defense and Veterans Pain Rating Scale (Pain Severity)

  Through study completion, an average of 6 months following workshop/intervention attendance.

Other Outcomes (3)

• Acceptance and Action Questionnaire-II

  Through study completion, an average of 6 months following workshop/intervention attendance.

• Valued Living Questionnaire (VLQ) - Success

  Through study completion, an average of 6 months following workshop/intervention attendance.

• Self-reported Service Utilization (Emotional Problems)

  Through study completion, an average of 6 months following workshop/intervention attendance.

Study Arms (2)

ACT on Life

ACTIVE COMPARATOR

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).

Behavioral: ACT on Life

Education, Resources, and Support

PLACEBO COMPARATOR

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

Behavioral: Education, Resources, and Support

Interventions

ACT on Life BEHAVIORAL

1 day group workshop of ACT plus ERS

Also known as: ACT plus ERS

ACT on Life

Education, Resources, and Support BEHAVIORAL

1 day group workshop of Education, Resources, and Support

Also known as: ERS

Education, Resources, and Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OIF/OEF/OND Veteran
• 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.)
• Deployment-related mild TBI according to the definition of VA/DOD Clinical Practice Guidelines and determined by interview on the Boston Assessment of TBI-Lifetime (BAT-L)
• Pain intensity and level of interference reported to be 5 (moderate) on the Defense and Veterans Pain Rating Scale (DVPRS)

You may not qualify if:

• History of bipolar disorder or primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) on the M.I.N.I.
• A current diagnosis of severe substance use disorder on the M.I.N.I.
• Moderate to severe suicide risk on the suicidality scale on the M.I.N.I.
• History of neurological illness not related to TBI (self-reported and confirmed by Dr. Jorge)
• Severe medical illness (e.g. liver failure, severe coronary artery disease and /or heart failure) posing a new and significant stress burden and requiring intensive treatment (self-reported and confirmed by Dr. Jorge)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Chronic Pain; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Multiple Trauma

Interventions

Educational Status; Health Resources; Palliative Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Lilian Dindo
• Organization: Baylor College of Medicine

lilian.dindo@bcm.edu

713-440-4637

Study Officials

• Lilian N. Dindo, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will not be told which group they are being allocated to. Follow-up assessments will be administered by anl interviewer blinded to patient assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: ACT plus Education, Resources and Support ('ACT on Life') workshop compared to Education, Resources, \& Support only workshop (ERS)

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: July 1, 2020
• Primary Completion: August 3, 2024
• Study Completion: August 3, 2024
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)