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Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04200976
Acronym
Tele-CABA
Enrollment
94
Registered
2019-12-16
Start date
2019-09-15
Completion date
2021-08-15
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, Traumatic Brain Injury

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.

Interventions

BEHAVIORALTele-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.

BEHAVIORALUsual Care

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

Sponsors

Oregon Health and Science University
CollaboratorOTHER
Portland VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtestBaseline; 12 weeks; and 6 months after baselineMeasure 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)Baseline; 12 weeks; and 6 months after baselineMeasure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)
Change in the Satisfaction with Life Scale (SWLS)Baseline; 12 weeks; and 6 months after baselineMeasure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026