Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07227987
Status
Not Yet Recruiting

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Conditions

  • Posttraumatic Stress Disorder (PTSD)
  • Traumatic Brain Injury (TBI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CALM (Cognitive Apps for Life Management) — OTHER
    GMT + 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
    Brain 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CALM (Cognitive Apps for Life Management)
  • Active Comparator: Psychoeducation

Primary Outcome Measure

Dimensions of Anger (DAR7) [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University School of MedicineDurhamNorth Carolina27710
Eric Elbogen
[email protected]
919-360-5498
Eric Elbogen, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University School of Medicine· Durham, NC

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