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

Summary

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.

Conditions

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

Interventions

OTHER

CALM (Cognitive Apps for Life Management)

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.

OTHER

Psychoeducation

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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs

  collaborator FED

• Duke University

  lead OTHER

Principal Investigators

• Eric Elbogen · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• United States

Study Locations