N/A
N=176
One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
Traumatic Brain Injury · Chronic Pain · Post Traumatic Stress Disorder · Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04143243 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score — 28.97; 30.77 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACT on Life (Behavioral); Education, Resources, and Support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Depression Anxiety and Stress Scale (DASS-21) -TOTAL Score |
28.97; 30.77 | — |
| PRIMARY Military to Civilian Questionnaire (M2C-Q) |
2.296; 2.395 | — |
| SECONDARY The PTSD Checklist for DSM-5 (PCL-5) |
42.38; 47.36 | — |
| SECONDARY Defense and Veterans Pain Rating Scale (Pain Severity) |
5.77; 5.87 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT04143243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.