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
Qualifiers
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
Does not own a smartphone.
Does not have a trusted support person, e.g., spouse, family member, or friend for enrollment
Trial design
Treatments tested in this trial
- CALM (Cognitive Apps for Life Management)
- Psychoeducation
Treatment groups
Sponsors and collaborators
Duke University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator