N/A
N=39
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
Mild Traumatic Brain Injury · Distress-based Psychopathology · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02844946 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: World Health Organization-Quality of Life (WHO-QOL) — 6.11; 5.20 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acceptance and Commitment Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY World Health Organization-Quality of Life (WHO-QOL) |
6.11; 5.20 | — |
| PRIMARY Depression Anxiety and Stress Scale (DASS-21) |
42.7; 65.6 | — |
| PRIMARY Brief Pain Inventory (BPI) |
5.3; 4.2 | — |
| PRIMARY World Health Organization Disability Assessment Schedule II (WHODAS-II) |
38.3; 41.7 | — |
| SECONDARY Military to Civilian Questionnaire (M2C-Q) |
1.81; 2.14 | — |
| SECONDARY PTSD Checklist-Civilian Version (PCL-C) |
49.2; 54.4 | — |
| SECONDARY Acceptance and Action Questionnaire-II (AAQ-II) |
22.8; 30.3 | — |
Summary
Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also experience significant distress, including depression and post-traumatic stress disorder, as well as persistent pain. Importantly, significant stigma is associated with seeking mental health care among Veterans; and poor management of multiple conditions results in increased morbidity and mortality, increased risk for suicide, and significantly decreased quality of life. Thus the challenge for treatment providers is to provide a unified and acceptable intervention for Veterans with these interdependent systemic comorbid concerns. The aim of this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to more than one diagnosis) "life skills workshop" to help Veterans develop skills needed to pursue valued goals in the face of life's challenges.
Eligibility Criteria
Inclusion Criteria
- 18-75 years of age
- Clinically significant psychological distress as operationalized by a diagnosis of major depressive disorder, generalized anxiety disorder, or PTSD
- Life time history of Mild TBI
- the Department of Veterans Affairs and the Department of Defense define TBI as a traumatically induced structural injury and/or physiological disruption of brain function that is associated with any period of loss of or a decreased level of consciousness
- any loss of memory for events immediately before or after the injury
- any alteration in mental state at the time of the injury
- neurological deficits that may or may not be transient
- or an intracranial lesion
- Mild TBI is characterized by loss of consciousness less than 30 minutes, a period of post-traumatic amnesia less than 24 hours or, if available, a Glasgow Coma Scale score of 13 to 15
- Presence in medical chart of chronic pain including headache, musculoskeletal pain or neuropathic pain
- Stable dose of psychiatric medications for the past 8 weeks
Exclusion Criteria
- History of primary psychotic disorder, e.g.,:
- schizophrenia
- schizoaffective disorder
- A diagnosis of substance dependence in the year prior to enrollment in the study
- Active suicidal ideation
- Homicidal ideation
Data sourced from ClinicalTrials.gov (NCT02844946). 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.