Back to resultsCognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD (CABA)
Primary Purpose
Traumatic Brain Injury, Posttraumatic Stress Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitively Augmented Behavioral Activation
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain injury, TBI, PTSD, Polytrauma
Eligibility 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.
Sites / Locations
- VA Portland Health Care System, Portland, OR
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CABA
TAU
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5
PTSD diagnosis.
Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5
PTSD diagnosis.
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
PTSD symptom severity.
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
PTSD symptom severity.
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
PTSD symptom severity.
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Postconcussion symptom severity.
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Postconcussion symptom severity.
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Postconcussion symptom severity.
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Measures symptoms of depression and severity.
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Measures symptoms of depression and severity.
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Measures symptoms of depression and severity.
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Measures suicidal ideation.
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Measures suicidal ideation.
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Measures suicidal ideation.
Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised
Measures learning and memory function.
Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised
Measures learning and memory function.
Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Measures attention and working memory function.
Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Measures attention and working memory function.
Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest
Measures processing speed.
Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest
Measures processing speed.
Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test
Measures fluency.
Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test
Measures fluency.
Secondary Outcome Measures
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Measures postconcussion symptom severity.
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Measures postconcussion symptom severity.
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Measures postconcussion symptom severity.
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Measures use of memory strategies in daily living.
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Measures use of memory strategies in daily living.
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Measures use of memory strategies in daily living.
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Measures symptoms of anxiety.
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Measures symptoms of anxiety.
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Measures symptoms of anxiety.
Change in health related quality of life from baseline as measured by the Neuro-QOL
Measures quality of life.
Change in health related quality of life from baseline as measured by the Neuro-QOL
Measures quality of life.
Change in health related quality of life from baseline as measured by the Neuro-QOL
Measures quality of life.
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Measures quality of life.
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Measures quality of life.
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Measures quality of life.
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Measures impact of functional impairment on activities.
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Measures impact of functional impairment on activities.
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Measures impact of functional impairment on activities.
Full Information
NCT ID
NCT02391402
First Posted
February 17, 2015
Last Updated
November 28, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02391402
Brief Title
Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Acronym
CABA
Official Title
Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2015 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Posttraumatic Stress Disorder
Keywords
Brain injury, TBI, PTSD, Polytrauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CABA
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitively Augmented Behavioral Activation
Other Intervention Name(s)
CABA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5
Description
PTSD diagnosis.
Time Frame
14 weeks
Title
Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5
Description
PTSD diagnosis.
Time Frame
39 weeks
Title
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
Description
PTSD symptom severity.
Time Frame
7 weeks
Title
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
Description
PTSD symptom severity.
Time Frame
14 weeks
Title
Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5
Description
PTSD symptom severity.
Time Frame
39 weeks
Title
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Description
Postconcussion symptom severity.
Time Frame
7 weeks
Title
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Description
Postconcussion symptom severity.
Time Frame
14 weeks
Title
Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory
Description
Postconcussion symptom severity.
Time Frame
39 weeks
Title
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Description
Measures symptoms of depression and severity.
Time Frame
7 weeks
Title
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Description
Measures symptoms of depression and severity.
Time Frame
14 weeks
Title
Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II
Description
Measures symptoms of depression and severity.
Time Frame
39 weeks
Title
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Description
Measures suicidal ideation.
Time Frame
7 weeks
Title
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Description
Measures suicidal ideation.
Time Frame
14 weeks
Title
Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation
Description
Measures suicidal ideation.
Time Frame
39 weeks
Title
Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised
Description
Measures learning and memory function.
Time Frame
14 weeks
Title
Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised
Description
Measures learning and memory function.
Time Frame
39 weeks
Title
Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Description
Measures attention and working memory function.
Time Frame
14 weeks
Title
Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Description
Measures attention and working memory function.
Time Frame
39 weeks
Title
Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest
Description
Measures processing speed.
Time Frame
14 weeks
Title
Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest
Description
Measures processing speed.
Time Frame
39 weeks
Title
Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test
Description
Measures fluency.
Time Frame
14 weeks
Title
Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test
Description
Measures fluency.
Time Frame
39 weeks
Secondary Outcome Measure Information:
Title
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Description
Measures postconcussion symptom severity.
Time Frame
7 weeks
Title
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Description
Measures postconcussion symptom severity.
Time Frame
14 weeks
Title
Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire
Description
Measures postconcussion symptom severity.
Time Frame
39 weeks
Title
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Description
Measures use of memory strategies in daily living.
Time Frame
7 weeks
Title
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Description
Measures use of memory strategies in daily living.
Time Frame
14 weeks
Title
Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire
Description
Measures use of memory strategies in daily living.
Time Frame
39 weeks
Title
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Description
Measures symptoms of anxiety.
Time Frame
7 weeks
Title
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Description
Measures symptoms of anxiety.
Time Frame
14 weeks
Title
Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory
Description
Measures symptoms of anxiety.
Time Frame
39 weeks
Title
Change in health related quality of life from baseline as measured by the Neuro-QOL
Description
Measures quality of life.
Time Frame
7 weeks
Title
Change in health related quality of life from baseline as measured by the Neuro-QOL
Description
Measures quality of life.
Time Frame
14 weeks
Title
Change in health related quality of life from baseline as measured by the Neuro-QOL
Description
Measures quality of life.
Time Frame
39 weeks
Title
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Description
Measures quality of life.
Time Frame
7 weeks
Title
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Description
Measures quality of life.
Time Frame
14 weeks
Title
Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale
Description
Measures quality of life.
Time Frame
39 weeks
Title
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Description
Measures impact of functional impairment on activities.
Time Frame
7 weeks
Title
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Description
Measures impact of functional impairment on activities.
Time Frame
14 weeks
Title
Change in functional impairment from baseline as measured by the Sheehan Disability Scale
Description
Measures impact of functional impairment on activities.
Time Frame
39 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Storzbach, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
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