Cognitive Apps for Life Management (CALM) to help Veterans with anger after TBI and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial will enroll 100 Veteran-family/friend dyads to test CALM, a mobile app-based cognitive rehabilitation program, for reducing anger dysregulation, impulsivity, and executive dysfunction in Veterans with TBI and PTSD. The study also aims to improve social/adaptive functioning and reduce PTSD symptoms and suicidal ideation compared with an active control. Participants include U.S. Veterans post-9/11 with TBI and PTSD or subthreshold PTSD, plus a supported family member or friend. The intervention leverages the Supervisory Attentional System framework to enhance inhibition, attention, self-monitoring, and planning through digital tools and psychoeducation. Primary outcomes focus on anger management and functional status over the course of treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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

Where it's running

• Duke University School of Medicine
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Eric Elbogen — Duke University
• Study coordinator: Janequia Evans
• Email: janequia.evans@duke.edu
• Phone: 19296607280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.