Clinical trial NCT02391402: Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Official title: Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Posttraumatic Stress Disorder
Keywords: Brain injury
TBI
PTSD
Polytrauma
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5
timeFrame: 0 weeks
measure: PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5
timeFrame: 14 weeks
measure: PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5
timeFrame: 0 weeks
measure: PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5
timeFrame: 14 weeks
measure: Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised
timeFrame: 0 weeks
measure: Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised
timeFrame: 14 weeks
measure: Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
timeFrame: 0 weeks
measure: Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
timeFrame: 14 weeks
measure: Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test
timeFrame: 0 weeks
measure: Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test
timeFrame: 14 weeks
measure: Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline
timeFrame: 0 weeks
measure: Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest
timeFrame: 14 weeks
Secondary outcomes:
measure: Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II
timeFrame: 0 weeks
measure: Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II
timeFrame: 14 weeks
measure: Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale
timeFrame: 0 weeks
measure: Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale
timeFrame: 14 weeks
measure: Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory
timeFrame: 0 weeks
measure: Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory
timeFrame: 14 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 14 weeks
Other outcomes:
measure: Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire
timeFrame: 0 weeks
measure: Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire
timeFrame: 14 weeks
measure: Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire
timeFrame: 0 weeks
measure: Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire
timeFrame: 14 weeks
measure: Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory
timeFrame: 0 weeks
measure: Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory
timeFrame: 14 weeks
measure: Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities.
timeFrame: 0 weeks
measure: Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities.
timeFrame: 14 weeks
measure: Functional Impairment From Baseline as Measured by the Sheehan Disability Scale
timeFrame: 0 weeks
measure: Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale
timeFrame: 14 weeks
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Megan Callahan, PsyD
role: PRINCIPAL_INVESTIGATOR
References: