Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- VA Office of Research and Development
- Enrollment
- 73
- Locations
- 2
- Primary Endpoint
- PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5
Time Frame: 0 weeks
The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.
Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised
Time Frame: 14 weeks
The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.
Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Time Frame: 14 weeks
The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.
PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5
Time Frame: 0 weeks
The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).
PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5
Time Frame: 14 weeks
The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).
PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5
Time Frame: 14 weeks
The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.
Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised
Time Frame: 0 weeks
The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.
Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
Time Frame: 0 weeks
The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.
Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test
Time Frame: 14 weeks
The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).
Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest
Time Frame: 14 weeks
The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.
Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test
Time Frame: 0 weeks
The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).
Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline
Time Frame: 0 weeks
The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.
Secondary Outcomes
- Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory(14 weeks)
- Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II(0 weeks)
- Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale(0 weeks)
- Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale(14 weeks)
- Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory(0 weeks)
- Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II(14 weeks)
- Client Satisfaction Questionnaire (CSQ)(14 weeks)