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

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ClinicalTrials.gov Identifier: NCT04143243
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date October 29, 2019
Estimated Study Start Date  ICMJE February 20, 2020
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • The Depression Anxiety and Stress Scale (DASS-21) [ Time Frame: 6 months ]
    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 shown adequate construct validity, internal consistency, and convergent and discriminant validity. It has been used extensively in clinical trials, including those with military populations
  • Military to Civilian Questionnaire (M2C-Q) [ Time Frame: 6 months ]
    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. The following domains are covered by the M2C-Q: Social relations, community engagement, perceived meaning in life, self-care and leisure, and parenting. Higher scores reflecting greater difficulty with reintegration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • The PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 6 months ]
    This self-report measure assesses symptoms of PTSD based on criteria of the Diagnostic and Statistical Manual for Mental Disorders - Version 5 (DSM-5). This 20-item scale is available from the National Center for PTSD and is extensively used in Veteran populations
  • Defense and Veterans Pain Rating Scale [ Time Frame: 6 months ]
    This pain assessment tool assesses severity of pain as well as the impact of pain on usual activity and sleep, on mood, and on stress levels. It utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and facial expressions matched to pain levels. It is a reliable and valid instrument developed for use in military populations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2019)
  • Acceptance and Action Questionnaire-II [ Time Frame: 6 months ]
    This self-report measures assesses experiential avoidance, or the tendency to avoid unwanted internal experiences (e.g., "I try hard to avoid feeling depressed or anxious"), as well as acceptance, the term used to describe the counter process (e.g., "My thoughts and feelings do not get in the way of how I want to live my life"). The AAQ was designed to measure mechanisms hypothesized to be at work in ACT treatments and has been found to mediate behavioral outcomes in ACT interventions 23. It has been shown to have good internal consistency and validity.
  • Valued Living Questionnaire (VLQ) [ Time Frame: 6 months ]
    This self-report measure assesses engagement in valued areas of life. Participants first rate the importance of 10 life domains (e.g., family, work, friends, spirituality, etc.) on a 10-point Likert scale (1 = not at all important to 10 = extremely important). They then rate the degree to which their actions over the past week were consistent with each value, from 1 (not at all consistent) to 10 (extremely consistent). The discrepancy between consistency and importance reflects the degree to which a person is engaging in meaningful life areas
  • Self-reported service utilization [ Time Frame: 6 months ]
    Frequency of visits for physical and emotional problems in inpatient, emergency room, and outpatient settings, as well as frequency of medical or community services during which emotional or functional problems were discussed will be assessed at each contact.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
Official Title  ICMJE One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change
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.
Detailed Description

Traumatic brain injury (TBI) is the signature wound of Veterans returning from Operations Iraqi Freedom, Operation Enduring Freedom and Operation New Dawn (OIF/OEF/OND), with up to 20 percent exposed to a mild TBI (mTBI) and experiencing persistent post-concussive symptoms. Among those with a mTBI diagnosis, the majority also suffers from stress-based psychopathology (e.g., depression, post-traumatic stress disorder, generalized anxiety disorder), as well as 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 significant barriers to engaging in mental health treatment, including stigma, the belief that one should overcome psychological difficulties on his/her own, and concern that receiving such care would negatively impact their careers. Practical barriers, including time constraints, distance from a treatment facility, and competing priorities (e.g., work and family demands), are also barriers to care. Even among Veterans who start mental health treatment, only a small minority complete a recommended course of evidence-based therapy.

Acceptance and Commitment Therapy (ACT) is a trans-diagnostic treatment model that helps patients to overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities. In this context, Veterans are asked to think about their "new mission(s)" after leaving the military and the importance of engaging in actions that fulfill their mission even when it may be difficult. ACT has established efficacy in the treatment of depression, anxiety, and chronic pain, and has been effectively implemented in various treatment-delivery formats, including 1-day group workshops. A 1-day ACT workshop addresses specific needs of Veterans with mTBI, stress-based psychopathology, and chronic pain (polytrauma triad) and important barriers to treatment. It 1) is trans-diagnostic (i.e., applies to more than one condition); 2) targets avoidance-based coping; 3) cultivates acceptance-based coping and builds on Veteran's values and goals to motivate them to make difficult decisions; 4) is delivered efficiently and thus more accessible; 5) is less stigmatizing and thus acceptable; and 6) address problems with treatment adherence and completion.

With the support of an RR&D SPiRE pilot grant, the PIs developed a 1-day 'ACT on Life' workshop tailored specifically for the needs of Veterans with mTBI, stress-based psychopathology, and chronic pain. Veterans with this polytrauma were then randomly assigned to the 'ACT on Life' workshop (N=20) or to Treatment as Usual (TAU; N=12). All Veterans attending the 1-day ACT workshop completed it, and relative to TAU, exhibited greater improvements in distress and reintegration at the 3-month follow-up (effect sizes .68 and .47, respectively). Building on these promising preliminary findings, the investigators now propose to conduct a more rigorous randomized controlled trial with 212 Veterans to compare the efficacy of the 1-day ACT workshop to an active treatment comparison (Education, Resources, and Support; ERS) on symptoms of distress and social, occupational, and community reintegration. The investigators will also examine mediators and moderators of treatment response to identify which ACT components are directly responsible for treatment effectiveness and whether treatment benefits are constrained by various personal factors.

Establishing the efficacy of a 1-day ACT workshop for OEF/OEF/OND Veterans with mTBI and multiple coexistent conditions addresses key priorities of VHA RR&D: 1. developing interventions which will improve the psychological health status of Veterans who have specific needs; and 2. enhancing the community, social, and occupational reintegration and functioning of post-deployment Veterans so that they may function more fully in society.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
ACT plus Education, Resources and Support ('ACT on Life') workshop compared to Education, Resources, & Support only workshop (ERS)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Chronic Pain
  • Post Traumatic Stress Disorder
  • Depression
  • Anxiety
Intervention  ICMJE
  • Behavioral: ACT on Life
    1 day group workshop of ACT plus ERS
    Other Name: ACT plus ERS
  • Behavioral: Education, Resources, and Support
    1 day group workshop of Education, Resources, and Support
    Other Name: ERS
Study Arms  ICMJE
  • Active Comparator: ACT on Life

    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).

    Intervention: Behavioral: ACT on Life
  • Placebo Comparator: Education, Resources, and Support
    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
    Intervention: Behavioral: Education, Resources, and Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2019)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura A Petersen, MD MPH (713) 794-8601 laura.petersen@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04143243
Other Study ID Numbers  ICMJE D3117-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lilian N. Dindo, PhD Michael E. DeBakey VA Medical Center, Houston, TX
PRS Account VA Office of Research and Development
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP