NCT07227987 · Duke University
Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD
(CALM)
What this study is about
This randomly assigned clinical trial will enroll 100 Veteran-family/friend dyads to test the effectiveness of CALM in treating anger in TBI and PTSD. The investigators hypothesize that compared to an active control group, Veterans randomly assigned to the CALM group will demonstrate: * Significantly larger decreases in anger dysregulation, impulsivity, and executive dysfunction.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 measures
Dimensions of Anger (DAR7)
Time frame: Baseline, 3 months, 6 months
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.
Barratt Impulsiveness Scale-11 (BIS-11)
Time frame: Baseline, 3 months, 6 months
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).
Delis-Kaplan Executive Function System (D-KEFS)
Time frame: Baseline, 3 months, 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Durham, North Carolina
Collaborators
Congressionally Directed Medical Research Programs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations