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One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844946
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Distress-based Psychopathology Chronic Pain Behavioral: Acceptance and Commitment Therapy Not Applicable

Detailed Description:

Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among those with a mild TBI (mTBI) diagnosis, the majority also suffers from stress-based psychopathology, including depression, post-traumatic stress disorder, and other anxiety disorders, as well as persistent pain. Poor management of multiple conditions results in increased morbidity and mortality, increased risk for suicide, and significantly decreased quality of life. Importantly, the association between seeking mental health care and stigma among Veterans is high. Veterans are often unwilling to seek mental health services due to concern that receiving such care would negatively impact their careers and the belief that they should be able to overcome psychological difficulties on their own. Furthermore availability of specialty services is limited for Veterans living in rural settings. Thus the challenge for treatment providers is to provide a unified, efficient, accessible, and acceptable intervention for Veterans with these interdependent systemic comorbid concerns. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic (i.e., applies to more than one diagnosis) behavioral intervention aimed at helping individuals develop the skills needed to pursue valued goals and directions in the face of life's challenges. It provides a unified model of behavior change that has shown promise in treating depression and anxiety, as well as chronic medical conditions. Importantly, ACT has been effectively implemented in various treatment-delivery formats, including 1-day workshops. This flexibility in delivery format allows focus to be placed on how best to package and deliver the intervention to meet the needs of this Veteran patient population, to ensure treatment adherence, and also to increase chances of dissemination into clinical settings. Providing a 1-day ACT "workshop" for Veterans with mTBI, pain, and mental health problems will allow unitary comprehensive care for the range of emotional, physical, and cognitive symptoms experienced by these Veterans. Presenting the treatment as a "workshop" rather than "therapy" will also be better suited for the Veterans who may not be explicitly seeking specialized mental health care. Finally, a 1-day workshop ensures treatment adherence and completion, the lack of which is often the greatest obstacle to effective delivery of mental health services.

The aims of this study are to:

  1. develop a 1-day (5-hour) "ACT on Life" workshop tailored specifically for Veterans with mTBI, stress-based psychopathology, and pain; a multi-disciplinary team of a clinical psychologist, neuropsychiatrist, cognitive psychologist, and anthropologist will provide expert input for use in producing the therapist intervention and patient manual;
  2. enroll 10 Veterans with mTBI, stress-based psychopathology, and pain in the "ACT on Life" workshop to obtain qualitative and quantitative feedback from Veterans about the intervention; use Veteran feedback to refine the treatment procedures and manuals; and examine feasibility and acceptability of the intervention; (this is called Pilot 1 and is the first time we recruited participants to obtain feedback on the intervention); and 3) randomize 30 Veterans with mTBI, pain, and stress-based psychopathology to the refined "ACT on Life" workshop or to Treatment as usual (TAU) to examine the preliminary efficacy of the intervention on quality of life and functioning, stress-based symptoms of psychopathology, and pain interference (this is called Pilot 2 and quantitative feedback was obtained). The results section will reflect data from Pilot 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: ACT on Life
One day workshop aimed at providing Veterans with new tools and skills needed to pursue valued goals and directions in the face of life's challenges. Mindfulness, acceptance, values clarification, and goal-setting will be taught.
Behavioral: Acceptance and Commitment Therapy
Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.

No Intervention: Treatment as Usual
Veterans will continue receiving care as usual.



Primary Outcome Measures :
  1. World Health Organization-Quality of Life (WHO-QOL) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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.

  2. Depression Anxiety and Stress Scale (DASS-21) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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.

  3. Brief Pain Inventory (BPI) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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).

  4. World Health Organization Disability Assessment Schedule II (WHODAS-II) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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).


Secondary Outcome Measures :
  1. Military to Civilian Questionnaire (M2C-Q) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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.

  2. PTSD Checklist-Civilian Version (PCL-C) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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.

  3. Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: Through study completion, an average of 3 months following workshop attendance ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844946


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lilian N. Dindo, PhD Michael E. DeBakey VA Medical Center, Houston, TX
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02844946     History of Changes
Other Study ID Numbers: D2209-P
First Posted: July 26, 2016    Key Record Dates
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Acceptance and Commitment Therapy
mild Traumatic Brain Injury
Veterans
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Chronic Pain
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms