Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Not Applicable

Completed

• Conditions: Traumatic Brain Injury; Posttraumatic Stress Disorder

• Registration Number: NCT04200976
• Lead Sponsor: Portland VA Medical Center

Brief Summary

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction.

The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-15
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Veterans
• Active Duty Service Members
• History of TBI (confirmed by TBI interview)
• Self-reported cognitive complaints (as indicated on the NSI)
• Able to communicate by telephone

Exclusion Criteria

• Active suicidal intent
• History of bipolar disorder
• History of psychotic disorder
• Decisionally impaired
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest	Baseline; 12 weeks; and 6 months after baseline	Measure of attention and working memory; scaled score range = 0-20 (mean = 10; SS below 2 SD below the mean considered impaired)
Change in the Neurobehavioral Symptom Inventory (NSI)	Baseline; 12 weeks; and 6 months after baseline	Measure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)
Change in the Satisfaction with Life Scale (SWLS)	Baseline; 12 weeks; and 6 months after baseline	Measure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)

Secondary Outcome Measures

Name	Time	Method
Change in the PTSD Checklist-5 (PCL 5)	Baseline; after 12 weeks; and 6 months after baseline	Measure of PTSD symptoms; total score range = 0-80 (higher total score = worse PTSD)
Change in the Memory Compensation Questionnaire (MCQ)	Baseline; after 12 weeks; and 6 months after baseline	Measure of the use of strategies to improve memory relevant to daily living; total score range = 0-176 (lower total score = worse functioning)

Trial Locations

Locations (1)

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States