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OpenTrials
Completed

NCT Number: NCT04200976

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

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

Primary outcomes

  1. Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest

    Time frame: 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)

  2. Change in the Neurobehavioral Symptom Inventory (NSI)

    Time frame: Baseline; 12 weeks; and 6 months after baseline

    Measure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)

  3. Change in the Satisfaction with Life Scale (SWLS)

    Time frame: Baseline; 12 weeks; and 6 months after baseline

    Measure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)

Secondary outcomes

  1. Change in the PTSD Checklist-5 (PCL 5)

    Time frame: Baseline; after 12 weeks; and 6 months after baseline

    Measure of PTSD symptoms; total score range = 0-80 (higher total score = worse PTSD)

  2. Change in the Memory Compensation Questionnaire (MCQ)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

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

Acronym: Tele-CABA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2019
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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