Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

NCT04200976 | Completed

• 1 other identifier: PortlandVAMC
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in the PTSD Checklist-5 (PCL 5)

  Baseline; after 12 weeks; and 6 months after baseline

• Change in the Memory Compensation Questionnaire (MCQ)

  Baseline; after 12 weeks; and 6 months after baseline

Study Arms (2)

Tele-CABA

EXPERIMENTAL

Participants who engage in the Tele-CABA intervention.

Behavioral: Tele-CABA

Usual Care

PLACEBO COMPARATOR

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

Interventions

Tele-CABA BEHAVIORAL

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.

Tele-CABA

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: September 15, 2019
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)