Cognitive Rehabilitation for Anger in TBI and PTSD

(CALM Trial)

Overseen By Janequia Evans

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: No smartphone, No support person

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called CALM (Cognitive Apps for Life Management), designed to help Veterans manage anger and impulsivity related to traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). The researchers aim to determine if this app can better control anger, reduce PTSD symptoms, and improve social interactions compared to a group receiving general brain health education. Veterans with anger issues following a head injury and difficulties with cognitive tasks might be suitable candidates. Participants will pair with a family member or friend for support and will use the app or receive education over three months, with regular video check-ins. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative ways to manage their symptoms and improve their quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CALM app is safe for Veterans with TBI and PTSD?

Research has shown that the CALM (Cognitive Apps for Life Management) mobile app has been tested for safety in veterans with traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Earlier studies indicated that the app helped reduce emotional issues like anger without causing major side effects. No serious problems were reported, suggesting that users generally tolerated it well.

This treatment remains under investigation, but current data suggests that CALM is safe for individuals with TBI and PTSD. Designed to help manage emotions, improve focus, and assist with daily tasks, it can be very beneficial for those dealing with these conditions. For those considering joining a trial, this evidence suggests that CALM could be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CALM (Cognitive Apps for Life Management) because it offers a fresh, tech-driven approach to managing anger for individuals with traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Unlike traditional therapies that rely heavily on face-to-face counseling or medication, CALM uses digital tools to help users develop coping strategies in real-time, making it more accessible and adaptable to individual needs. This innovative use of technology could empower patients to manage their emotions more independently and effectively, offering a promising alternative to standard treatments like cognitive behavioral therapy or medication.

What evidence suggests that the CALM app is effective for treating anger in TBI and PTSD?

Research has shown that the CALM app, which participants in this trial may receive, helps reduce emotional issues for Veterans with traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). An early study found that using CALM lowered feelings of anger and related problems. Veterans using the app found it easier to control their emotions. The app also lessened PTSD symptoms, making it easier for Veterans to manage social and work situations. These findings suggest that CALM could be a promising tool for managing anger and improving overall well-being in Veterans with these conditions. Another group in this trial will receive psychoeducation, serving as an active comparator. ^{1 2 6 7 8}

Who Is on the Research Team?

Eric Elbogen

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for Veterans with TBI and PTSD who struggle with anger and impulsivity. Participants will be paired with a family member or friend, must have access to a mobile device for the app, and be willing to engage in videoconference calls.

Inclusion Criteria

I have been diagnosed with a traumatic brain injury.

I am at least 18 years old.

U.S. Veteran who served in one of the military branches (Army, Navy, Marines, Air Force, or Coast Guard) since 9/11/01

Exclusion Criteria

Does not own a smartphone

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the CALM mobile app or receive brain health education for three months, with support through videoconference calls at the beginning, middle, and end of the program

12 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CALM (Cognitive Apps for Life Management)

Trial Overview The CALM (Cognitive Apps for Life Management) mobile app is being tested against psychoeducation to see if it can better help manage anger, impulsivity, executive dysfunction, social functioning, PTSD symptoms, and suicidal ideation in Veterans.

How Is the Trial Designed?

Group I: CALM (Cognitive Apps for Life Management) Experimental Treatment 1 Intervention

Group II: Psychoeducation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6314886/

Cognitive Rehabilitation with Mobile Technology and Social ... This preliminary study demonstrated effectiveness of CALM for reducing emotional dysregulation in veterans with TBI and PTSD. Keywords: traumatic brain injury, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07227987

Cognitive Rehabilitation for Treatment of Anger in Veterans ... This randomized clinical trial will enroll 100 Veteran-family/friend dyads to test the efficacy of CALM in treating anger in TBI and PTSD.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30169439/

Cognitive Rehabilitation With Mobile Technology and ... This preliminary study demonstrated effectiveness of CALM for reducing emotional dysregulation in veterans with TBI and PTSD.

4. journals.lww.com journals.lww.com/10.1097/HTR.0000000000000435

The Journal of Head Trauma Rehabilitation This article describes a randomized clinical trial testing the effects of a cognitive rehabilitation intervention called Cognitive Applications for Life ...

5. researchgate.net researchgate.net/publication/326423205_Cognitive_Rehabilitation_With_Mobile_Technology_and_Social_Support_for_Veterans_With_TBI_and_PTSD_A_Randomized_Clinical_Trial

A Randomized Clinical Trial | Request PDF The Cognitive Applications for Life Management (CALM) app, for example, effectively reduced emotional dysregulation and PTSD symptoms in ...

6. mdpi.com mdpi.com/2075-1729/14/7/891

Mobile Application Applied for Cognitive Rehabilitation This study systematically reviewed and analyzed the literature on mobile apps for cognitive rehabilitation.

7. formative.jmir.org formative.jmir.org/2025/1/e64174

A New Mobile App to Train Attention Processes in People With ... This tool can be tested to train attention processes after a neurological insult such as traumatic brain injury.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660268/

Feasibility of a mobile app for traumatic stress management ... This study aimed to test the effects of the mobile app for traumatic stress management using neurofeedback-based meditation and binaural beat music.