N/A Completed N=73 Randomized Single-blind Treatment

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

Traumatic Brain Injury · Posttraumatic Stress Disorder

Source: ClinicalTrials.gov NCT02391402 ↗

Enrolled (actual)

Serious AEs

1.4%

Results posted

Jul 2024

Primary outcomePrimary: PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 — 40.62; 40.53 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5	40.62; 40.53	—
PRIMARY PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5	33.32; 37.35	—
PRIMARY PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5	50.15; 51.21	—
PRIMARY PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5	44.92; 52.17	—
PRIMARY Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised	35.05; 33.74	—
PRIMARY Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised	45.33; 37.30	—
PRIMARY Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest	8.95; 9.22	—
PRIMARY Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest	10.46; 9.40	—
PRIMARY Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test	43.68; 43.54	—
PRIMARY Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test	44.92; 41.05	—
PRIMARY Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline	9.08; 8.30	—
PRIMARY Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest	10.61; 9.79	—
SECONDARY Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II	29.74; 30.10	—
SECONDARY Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II	24.96; 31.17	—
SECONDARY Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale	15.38; 15.41	—
SECONDARY Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale	16.92; 15.32	—
SECONDARY Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory	45.79; 46.38	—
SECONDARY Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory	42.72; 49.43	—
SECONDARY Client Satisfaction Questionnaire (CSQ)	27.75; 27.24	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02391402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.