Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
This randomized clinical trial will enroll 100 Veteran-family/friend dyads to test the efficacy of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomized to the CALM group will demonstrate:
* Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction. * Significantly larger improvements in social and adaptive functioning including less aggression. * Significantly larger reduction in PTSD symptoms and suicidal ideation.
The study targets Veterans who experience difficulties with anger and impulsivity due to TBI and PTSD. These issues are common, with up to 38% of Veterans with TBI also having PTSD. These conditions often make it challenging for Veterans to control their emotions and interact successfully in social and work settings. Our research will test the CALM (Cognitive Applications for Life Management) mobile app, which helps Veterans manage their goals, remember important tasks, and improve their attention. Initial tests of CALM have shown it can reduce levels of anger and related issues in Veterans. The investigators will conduct a study with 100 pairings of Veterans and a family member or friend. These pairs will be randomly assigned to one of two groups: one using the CALM mobile platform and the other receiving brain health education. Both groups will use their assigned intervention for three months and will receive support through videoconference calls at the beginning, middle, and end of the program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since 9/11/01
Meets criteria for TBI
Meets criteria for PTSD or subthreshold PTSD
Reports anger problems began after their head injury
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
CALM (Cognitive Apps for Life Management)
Other interventionGMT + content-free cueing + n-back task 1. Goal Management Training: cognitive strategies to help Veterans improve goal-setting, planning, and self-monitoring in real world contexts. 2. Content-free cueing: intermittent prompts to conduct an "executive review" received four times daily on participant's smartphone, aimed to help improve goal-directed actions and self-monitoring of one's behavior. 3. N-back task: Veterans practice an n-back task via the mobile app, which aims to improve working memory and inhibitory control.
Psychoeducation
Other interventionBrain Health Training + Concussion Coach app Participants in the active control group will receive psychoeducational material as part of the "Brain Health Training" used as a control in cognitive rehabilitation and Goal Management Training (GMT). Veterans will also use "Concussion Coach," a VA and DoD app providing resources on TBI and cognitive functioning tips.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CALM (Cognitive Apps for Life Management)Experimental treatment 1 intervention
Group B: PsychoeducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dimensions of Anger (DAR7)
The Dimensions of Anger Reactions-7 (DAR-7) measures an individual's propensity to experience, express, and manage anger. It consists of 7 items assessing anger frequency, intensity, duration, and the impact on behavior and relationships.
Time frame
Baseline, 3 months, 6 months2
Barratt Impulsiveness Scale-11 (BIS-11)
Barratt Impulsiveness Scale-11 is designed to measure impulsivity as a personality trait. It includes 30 items that assess three key dimensions: attentional impulsiveness (lack of focus), motor impulsiveness (acting without thinking), and non-planning impulsiveness (lack of forethought).
Time frame
Baseline, 3 months, 6 months3
Delis-Kaplan Executive Function System (D-KEFS)
The Delis-Kaplan Executive Function System (D-KEFS) is a comprehensive battery of neuropsychological tests designed to assess a wide range of executive functions, such as problem-solving, cognitive flexibility, inhibition, and planning. It includes nine stand-alone subtests that evaluate higher-order thinking skills involved in goal-directed behavior.
Time frame
Baseline, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov