Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) (Tele-CABA)
Primary Purpose
Traumatic Brain Injury, Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-CABA
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- VA Portland Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tele-CABA
Usual Care
Arm Description
Participants who engage in the Tele-CABA intervention.
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).
Outcomes
Primary Outcome Measures
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)
Change in the Neurobehavioral Symptom Inventory (NSI)
Measure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)
Change in the Satisfaction with Life Scale (SWLS)
Measure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)
Secondary Outcome Measures
Change in the PTSD Checklist-5 (PCL 5)
Measure of PTSD symptoms; total score range = 0-80 (higher total score = worse PTSD)
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)
Full Information
NCT ID
NCT04200976
First Posted
December 12, 2019
Last Updated
April 21, 2022
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT04200976
Brief Title
Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)
Acronym
Tele-CABA
Official Title
Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-CABA
Arm Type
Experimental
Arm Description
Participants who engage in the Tele-CABA intervention.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Tele-CABA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.
Primary Outcome Measure Information:
Title
Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest
Description
Measure of attention and working memory; scaled score range = 0-20 (mean = 10; SS below 2 SD below the mean considered impaired)
Time Frame
Baseline; 12 weeks; and 6 months after baseline
Title
Change in the Neurobehavioral Symptom Inventory (NSI)
Description
Measure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)
Time Frame
Baseline; 12 weeks; and 6 months after baseline
Title
Change in the Satisfaction with Life Scale (SWLS)
Description
Measure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)
Time Frame
Baseline; 12 weeks; and 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in the PTSD Checklist-5 (PCL 5)
Description
Measure of PTSD symptoms; total score range = 0-80 (higher total score = worse PTSD)
Time Frame
Baseline; after 12 weeks; and 6 months after baseline
Title
Change in the Memory Compensation Questionnaire (MCQ)
Description
Measure of the use of strategies to improve memory relevant to daily living; total score range = 0-176 (lower total score = worse functioning)
Time Frame
Baseline; after 12 weeks; and 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)
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