Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) (Tele-CABA)

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Tele-CABA; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-CABA; Participants who engage in the Tele-CABA intervention.	Behavioral: Tele-CABA; Tele-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 Tele-CABA focus on learning about TBI 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. The Tele-CABA intervention will be delivered over 10 weekly, 60-minute telephone sessions.
Placebo Comparator: Usual Care; Participants who do not engage in the Tele-CABA intervention during their time in the study. They will be eligible to receive Tele-CABA following completion of the 6-month questionnaires and cognitive assessment (as a courtesy).	Behavioral: Usual Care; Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Portland VA Medical Center
• Collaborators: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Brain Injuries; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic
• Other Study ID Numbers: PortlandVAMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No