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

NCT07227987 | Not Yet Recruiting DMC

• 2 other identifiers: Pro00118644CDMRP-TP240244
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Dimensions of Anger (DAR7)

  The Dimensions of Anger Reactions-7 (DAR-7) measures an individual's propensity to experience, express, and manage anger. It consists of 7 items assessing anger frequency, intensity, duration, and the impact on behavior and relationships.

  Baseline, 3 months, 6 months

• Barratt Impulsiveness Scale-11 (BIS-11)

  Barratt Impulsiveness Scale-11 is designed to measure impulsivity as a personality trait. It includes 30 items that assess three key dimensions: attentional impulsiveness (lack of focus), motor impulsiveness (acting without thinking), and non-planning impulsiveness (lack of forethought).

  Baseline, 3 months, 6 months

• Delis-Kaplan Executive Function System (D-KEFS)

  The Delis-Kaplan Executive Function System (D-KEFS) is a comprehensive battery of neuropsychological tests designed to assess a wide range of executive functions, such as problem-solving, cognitive flexibility, inhibition, and planning. It includes nine stand-alone subtests that evaluate higher-order thinking skills involved in goal-directed behavior.

  Baseline, 3 months, 6 months

Study Arms (2)

CALM (Cognitive Apps for Life Management)

EXPERIMENTAL

Other: CALM (Cognitive Apps for Life Management)

Psychoeducation

ACTIVE COMPARATOR

Other: Psychoeducation

Interventions

CALM (Cognitive Apps for Life Management) OTHER

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.

CALM (Cognitive Apps for Life Management)

Psychoeducation OTHER

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Over age 18;
• 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.

Sponsors & Collaborators

• Duke University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Eric Elbogen

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janequia Evans

CONTACT

19296607280; janequia.evans@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To maintain blinding of the 3-month and 6-month interviewers to participants' treatment assignments: 1) The first interviewer will collect study equipment at follow-ups; 2) A different interviewer will handle the 3- and 6-month interviews; 3) Participants will be instructed not to discuss their intervention details during follow-up; and 4) The participant tracking database will be protected, accessible only to study coordinators who conducted the baseline assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant dyads will be randomized to either Cognitive Rehabilitation (n=50) or Psychoeducation (n=50).

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 13, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data uploaded to FITBIR on a quarterly basis, per Data Sharing Policy.
• Access Criteria: All links with participants identity will be removed from the data before they are shared. Only de-identified data which do not include anything that might directly identify participants will be shared with FITBIR users and the general scientific community for research purposes.

Locations

US (1)