Chronic Pain Clinical Trial
Official title:
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
Verified date | November 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | December 31, 2018 |
Est. primary completion date | September 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Dindo L, Johnson AL, Lang B, Rodrigues M, Martin L, Jorge R. Development and evaluation of an 1-day Acceptance and Commitment Therapy workshop for Veterans with comorbid chronic pain, TBI, and psychological distress: Outcomes from a pilot study. Contemp C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | World Health Organization-Quality of Life (WHO-QOL) | Quality of Life. The general Quality of Life scale includes 2 items that measure overall QOL and general health. Items scored are scored from 1-5 so the range for the this scale is 2-10 with higher scores representing higher quality of life. | Through study completion, an average of 3 months following workshop attendance | |
Primary | Depression Anxiety and Stress Scale (DASS-21) | Consists of three self-report scales that measure current depression, anxiety, and stress. This 21-item measure consists of three self-report scales that measure current symptoms of depression, anxiety, and stress and a total score. It has been used extensively in clinical trials, including those with military populations. Higher scores represent greater distress and scores range from 0-126. | Through study completion, an average of 3 months following workshop attendance | |
Primary | Brief Pain Inventory (BPI) | Assesses the severity of pain and the impact of pain on daily functions. The BPI severity scale assesses pain at its "worst," "least," "average," and "now" (current pain). A composite of the four pain items (a mean severity score) is used here as recommended for assessing pain in clinical trials. Higher scores represent greater severity (0-10). | Through study completion, an average of 3 months following workshop attendance | |
Primary | World Health Organization Disability Assessment Schedule II (WHODAS-II) | Assesses functioning and disability due to health conditions. Six domains are covered: understanding and communicating, getting around, self-care, getting along with people, life act. This is a self-report measure that assesses behavioral and functional impairments as a separate domain from disease symptoms. Higher scores indicate higher disability (from 0-100). | Through study completion, an average of 3 months following workshop attendance | |
Secondary | Military to Civilian Questionnaire (M2C-Q) | This 16-item self-report measure assesses post-deployment difficulties with reintegration during the previous month. Respondents rate the level of difficulty on a 5-point scale from No Difficulty to Extreme Difficulty (0-4). The following domains are covered by the M2C-Q: Social relations, community engagement, perceived meaning in life, self-care and leisure, and parenting. The total score is the average of the 16 items. Higher scores reflecting greater difficulty with reintegration. | Through study completion, an average of 3 months following workshop attendance | |
Secondary | PTSD Checklist-Civilian Version (PCL-C) | PCL-C is a 17-item self-report questionnaire assessing the presence and severity of DSM-IV symptoms of PTSD during the past month. All items are added for a total severity score. Higher scores represent greater severity of PTSD symptoms. Scores range from 1-85. | Through study completion, an average of 3 months following workshop attendance | |
Secondary | Acceptance and Action Questionnaire-II (AAQ-II) | The AAQ-II is an ACT-specific self-report measure of psychological inflexibility. Seven items are rated on a 7-point scale, ranging from 1 ("never true") to 7 ("always true"), with higher scores reflecting greater inflexibility. Scores range from 1-49. Example items include, "Emotions cause problems in my life," and "My painful memories prevent me from having a fulfilling life." It has been shown to have good internal consistency and validity and also to mediate behavioral outcomes in ACT interventions. | Through study completion, an average of 3 months following workshop attendance |
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