Traumatic Brain InjuryTele-CABANCT04200976
Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)
A study testing Tele-CABA in people with Traumatic Brain Injury and Posttraumatic Stress Disorder, run by Portland VA Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Posttraumatic Stress Disorder
- What is being tested?
- Tele-CABA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active suicidal intent
- History of bipolar disorder
- History of psychotic disorder
- Decisionally impaired
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
Official title: Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury
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.
- Being tested
- Tele-CABA, Usual Care
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-CABABehavioural
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 CareBehavioural
Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.
| Study group | Role | What they receive |
|---|---|---|
| Tele-CABA | Experimental | Participants who engage in the Tele-CABA intervention. Receives: 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). Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline; 12 weeks; and 6 months after baseline
Secondary outcomes (2)
Change in the PTSD Checklist-5 (PCL 5)
Measure of PTSD symptoms; total score range = 0-80 (higher total score = worse PTSD)
Measured: Baseline; after 12 weeks; and 6 months after baseline
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)
Measured: Baseline; after 12 weeks; and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start15 Sep 2019
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Megan Callahan, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200976
- Sponsor's protocol ID
- PortlandVAMC
- Acronym
- Tele-CABA
- Status last verified
- Apr 2022
- First submitted
- 12 Dec 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04200976
- Acronym / sponsor ID
- Tele-CABA / PortlandVAMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-CABA | Experimental | Behavioral: Tele-CABAParticipants who engage in the Tele-CABA intervention. |
| Usual Care | Placebo comparator | Behavioral: Usual CareParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Active suicidal intent
- History of bipolar disorder
- History of psychotic disorder
- Decisionally impaired
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-CABATele-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. | Behavioural | Tele-CABA |
| Usual CareParticipants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care. | Behavioural | Usual Care |
Primary outcome
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)
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)
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)
2 secondary outcomes
Change in the PTSD Checklist-5 (PCL 5)
Time frame: Baseline; after 12 weeks; and 6 months after baseline
Change in the Memory Compensation Questionnaire (MCQ)
Time frame: Baseline; after 12 weeks; and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-CABA in people with Traumatic Brain Injury and Posttraumatic Stress Disorder, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (time frame: Baseline; 12 weeks; and 6 months after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.