Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Traumatic Brain Injury Clinical Trial

— Tele-CABA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200976
• Other study ID #: PortlandVAMC
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: August 15, 2021

Study information

• Verified date: April 2022
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Traumatic Brain Injury

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.
• Usual Care
Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Portland VA Medical Center	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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