CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Cognitively Augmented Behavioral Activation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02391402
NCT02391402N/ACompleted

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

VA Office of Research and Development·interventional·Posted Mar 18, 2015·Updated Jul 8, 2024

In Brief

A clinical study evaluating Cognitively Augmented Behavioral Activation and Treatment as Usual for Traumatic Brain Injury and Posttraumatic Stress Disorder. Completed, enrolled 73 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 18, 2015
Enrollment StartMay 4, 2015
Primary CompletionMar 31, 2021
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.3 years ago

Interventions

Cognitively Augmented Behavioral Activationbehavioral

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 Usualbehavioral

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.