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Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD (CABA)

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ClinicalTrials.gov Identifier: NCT02391402
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Posttraumatic Stress Disorder Behavioral: Cognitively Augmented Behavioral Activation Behavioral: Treatment as Usual Not Applicable

Detailed Description:

Veterans historically exhibit high rates of comorbid mTBI/PTSD. Given the comorbidity and neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether problems and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is challenging for providers to know how to prioritize these patients' clinical issues and how to effectively treat them. Currently, there are no evidence-based treatments for comorbid mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be adherently and effectively implemented for the other. As such, most current treatment recommendations suggest a holistic or integrated approach to treatment for comorbid mTBI/PTSD targeting symptoms and functionality rather than underlying etiology. Investigators are proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and quality of life.

The study design makes use of the convergent availability of resources at the two participating Veterans Administration Health Care Systems in Portland, Oregon, and Seattle, Washington to conduct a Randomized Controlled Trial (RCT) of CABA. The study will recruit a total of 192 Veterans less than or equal to 55 years of age, 96 participants at each site, enrolled at participating VA Medical Centers (VAMCs) who are diagnosed with both mTBI and PTSD. Eligible participants will be randomly assigned to either the CABA or Treatment as Usual (TAU) group. Participants in the CABA group will receive the CABA intervention during the first 14 weeks of their participation in the study, whereas TAU participants will continue to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during their participation in the study. Both groups will undergo evaluations at baseline, 7 weeks (mid-treatment), 14 weeks (post-treatment), and 39 weeks (6 month follow-up). During their study participation, all participants will continue to receive their usual medical care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Actual Study Start Date : May 4, 2015
Estimated Primary Completion Date : March 28, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: CABA
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Behavioral: Cognitively Augmented Behavioral Activation
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Other Name: CABA

Placebo Comparator: TAU
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Behavioral: Treatment as Usual
TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Other Name: TAU




Primary Outcome Measures :
  1. Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5 [ Time Frame: 14 weeks ]
    PTSD diagnosis.

  2. Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5 [ Time Frame: 39 weeks ]
    PTSD diagnosis.

  3. Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5 [ Time Frame: 7 weeks ]
    PTSD symptom severity.

  4. Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5 [ Time Frame: 14 weeks ]
    PTSD symptom severity.

  5. Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5 [ Time Frame: 39 weeks ]
    PTSD symptom severity.

  6. Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory [ Time Frame: 7 weeks ]
    Postconcussion symptom severity.

  7. Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory [ Time Frame: 14 weeks ]
    Postconcussion symptom severity.

  8. Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory [ Time Frame: 39 weeks ]
    Postconcussion symptom severity.

  9. Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II [ Time Frame: 7 weeks ]
    Measures symptoms of depression and severity.

  10. Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II [ Time Frame: 14 weeks ]
    Measures symptoms of depression and severity.

  11. Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II [ Time Frame: 39 weeks ]
    Measures symptoms of depression and severity.

  12. Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation [ Time Frame: 7 weeks ]
    Measures suicidal ideation.

  13. Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation [ Time Frame: 14 weeks ]
    Measures suicidal ideation.

  14. Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation [ Time Frame: 39 weeks ]
    Measures suicidal ideation.

  15. Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised [ Time Frame: 14 weeks ]
    Measures learning and memory function.

  16. Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised [ Time Frame: 39 weeks ]
    Measures learning and memory function.

  17. Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest [ Time Frame: 14 weeks ]
    Measures attention and working memory function.

  18. Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest [ Time Frame: 39 weeks ]
    Measures attention and working memory function.

  19. Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest [ Time Frame: 14 weeks ]
    Measures processing speed.

  20. Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest [ Time Frame: 39 weeks ]
    Measures processing speed.

  21. Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test [ Time Frame: 14 weeks ]
    Measures fluency.

  22. Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test [ Time Frame: 39 weeks ]
    Measures fluency.


Secondary Outcome Measures :
  1. Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire [ Time Frame: 7 weeks ]
    Measures postconcussion symptom severity.

  2. Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire [ Time Frame: 14 weeks ]
    Measures postconcussion symptom severity.

  3. Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire [ Time Frame: 39 weeks ]
    Measures postconcussion symptom severity.

  4. Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire [ Time Frame: 7 weeks ]
    Measures use of memory strategies in daily living.

  5. Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire [ Time Frame: 14 weeks ]
    Measures use of memory strategies in daily living.

  6. Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire [ Time Frame: 39 weeks ]
    Measures use of memory strategies in daily living.

  7. Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory [ Time Frame: 7 weeks ]
    Measures symptoms of anxiety.

  8. Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory [ Time Frame: 14 weeks ]
    Measures symptoms of anxiety.

  9. Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory [ Time Frame: 39 weeks ]
    Measures symptoms of anxiety.

  10. Change in health related quality of life from baseline as measured by the Neuro-QOL [ Time Frame: 7 weeks ]
    Measures quality of life.

  11. Change in health related quality of life from baseline as measured by the Neuro-QOL [ Time Frame: 14 weeks ]
    Measures quality of life.

  12. Change in health related quality of life from baseline as measured by the Neuro-QOL [ Time Frame: 39 weeks ]
    Measures quality of life.

  13. Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale [ Time Frame: 7 weeks ]
    Measures quality of life.

  14. Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale [ Time Frame: 14 weeks ]
    Measures quality of life.

  15. Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale [ Time Frame: 39 weeks ]
    Measures quality of life.

  16. Change in functional impairment from baseline as measured by the Sheehan Disability Scale [ Time Frame: 7 weeks ]
    Measures impact of functional impairment on activities.

  17. Change in functional impairment from baseline as measured by the Sheehan Disability Scale [ Time Frame: 14 weeks ]
    Measures impact of functional impairment on activities.

  18. Change in functional impairment from baseline as measured by the Sheehan Disability Scale [ Time Frame: 39 weeks ]
    Measures impact of functional impairment on activities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans 55 years of age enrolled at participating VA sites able to provide informed consent.
  • Diagnosis of PTSD based on the Clinician Administered PTSD Scale.
  • Positive screen on the Structured Interview for Collecting Head Trauma Event Characteristics as per the VA/Department of Defense (DoD) Clinical Practice Guideline for Management of Concussion/mTBI; AND endorsed any of the Neurobehavioral Symptom Inventory (NSI) cognitive symptoms items (items 13-17).
  • English speaking, able to travel to the primary care clinics weekly for 10 sessions and for the follow-up assessments, and willing to refrain from the initiation of additional mental health treatment during the first 3 1/2 months of the active phase of treatment if they are assigned to the CABA condition.
  • Willingness to participate in audio-recorded sessions. (for treatment adherence)

Exclusion Criteria:

  • Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5 criteria within the past 30 days.
  • Individuals with other psychiatric diagnoses will not be excluded except for bipolar disorder and psychotic disorders (requirement to refrain from additional treatments might be harmful).
  • Veterans with a history indicated by medical record review of a diagnosis of moderate, severe, or penetrating TBI, or self-reported history on the Structured Interview for Collecting Head Trauma Event Characteristics of TBI with Post-Traumatic Amnesia (PTA) greater than 24 hours or loss of consciousness (LOC) greater than 30 minutes.
  • Active suicidal intent indicating significant clinical risk, which would suggest that a treatment specifically targeting this intent was indicated. Clients who report suicidal ideation without imminent risk will be admitted into the study.
  • Initiated psychotropic medication, including Prazosin, within 4 weeks or changed dosage within 2 weeks prior to the first assessment, as this would make it difficult to determine which treatment contributed to change in the CABA condition; additionally, started or changed dosage of sleep medication or low dosages of tricyclic antidepressant or trazodone for pain or sleep within 1 week prior to the first assessment. Participants could be reconsidered for eligibility after stability on medication was achieved. Enrollees will be asked to hold the doses of the current medications stable over the course of enrollment (though changes in medications after enrollment will not exclude them from on-going participation).
  • Auditory or visual impairments that would compromise ability to participate or benefit.

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): NCT02391402


Contacts
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Contact: Daniel M Storzbach, PhD (503) 220-8262 ext 56497 daniel.storzbach@va.gov
Contact: Megan L Callahan, PsyD (503) 220-8262 ext 50525 megan.callahan@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel M Storzbach, PhD    503-220-8262 ext 56497    daniel.storzbach@va.gov   
Principal Investigator: Daniel M Storzbach, PhD         
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Matthew Jakupcak, PhD    206-762-1010    matthew.jakupcak@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Daniel M Storzbach, PhD VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02391402     History of Changes
Other Study ID Numbers: D1189-I
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 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:
Brain injury
TBI
PTSD
Polytrauma

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders