Recruiting

CALM

Sponsor:

Duke University

Code:

NCT07227987

Conditions

Traumatic Brain Injury (TBI)

Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CALM (Cognitive Apps for Life Management)

Psychoeducation

Study Details

Brief 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)

Study ID

NCT07227987

Start date

Aug 4, 2026

Status verified date

Nov, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CALM (Cognitive Apps for Life Management)

active comparator: Psychoeducation

Interventions

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.

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.

Primary outcome measure

  • Dimensions of Anger (DAR7) [ Time Frame: Baseline, 3 months, 6 months ]
  • Barratt Impulsiveness Scale-11 (BIS-11) [ Time Frame: Baseline, 3 months, 6 months ]
  • Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Locations

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Eric Elbogen, PhD

More Information

Sponsor

Duke University

Last update posted

Aug 6, 2026

Last verified

Nov, 2025

Keywords

  • Traumatic Brain Injury (TBI)
  • Posttraumatic stress Disorder (PTSD)
  • Mobile app
  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-06.