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

Recruiting now · Not applicable

Conditions studied: Traumatic Brain Injury (TBI), Posttraumatic Stress Disorder (PTSD)

In brief

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 facts

Study ID

NCT07227987

Run by

Duke University

People needed

100

Starts

2026-08-04

Expected to finish

2028-12-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for Veterans
• 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
• Reports current problems with cognitive function
• At least 18 years old
• Fluent and literate in English
• Able to provide voluntary, informed consent to participate.
• Smartphone Use: Has an iPhone (iPhone 11 or higher with iOS 17 or higher) or Android (Android 8.0 or higher) smartphone.
• Inclusion Criteria for Family members or Friends:
• Over age 18;
• Family member/friend of Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, National Guard) post-9/11 and who meets TBI and PTSD inclusion criteria. (Veterans select this trusted family member or friend to serve as a support person for the study).
• Fluent and literate in English
• Able to provide voluntary, informed consent to participate.

You may not qualify if…

• Does not have a trusted support person, e.g., spouse, family member, or friend for enrollment.

Where it is running

• Duke University School of Medicine — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.