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

NCT ID: NCT07227987

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-31

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.

Detailed Description

In military populations, traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) frequently co-occur, with prevalence rates indicating that 34% to 38% of Service members and Veterans diagnosed with TBI also meet criteria for PTSD. Brain areas affected by TBI are implicated in PTSD, particularly in the frontal lobe involved in executive function and emotional and behavioral regulation. Veterans with TBI and PTSD often face challenges such as biological dysregulation secondary to brain injury, including difficulty managing anger, diminished inhibitory control, and increased aggression and suicide.

Interventions aimed at effectively addressing these adverse outcomes are limited, however. As noted in the Centers for Disease Control (CDC) report cited in the current CDMRP Program Announcement, PTSD-focused and mind-body treatments for anger have proven ineffective. For that reason, there is a critical imperative to discover other methods to reduce anger and impulsivity in Service members and Veterans with TBI and PTSD. Given neural mechanisms implicated in TBI and PTSD, an alternative approach to directly treat anger is to improve executive function itself. The Supervisory Attentional System (SAS) conceptualizes executive function as involving inhibition, attention, self-monitoring, and planning. These processes, along with emotional regulation, are key targets of a theory-based cognitive rehabilitation of executive function.

To improve executive function in TBI, research supports use of multiple approaches to optimize self-monitoring, emotion regulation, and self-control. One evidence-based intervention for executive function in TBI is goal management training (GMT). GMT trains individuals with TBI to set self-directed personal goals (e.g., work, school, fitness), break complex tasks into steps, and monitor attention to gain cognitive control. Multiple systematic reviews show GMT improves outcomes such as emotional regulation and social functioning, including among Veterans and non-Veterans with co-occurring TBI and PTSD. Another related approach involves external cues which can be used to encourage individuals with TBI to practice goal-directed behavior in real-world situations by prompting an "executive review" (e.g., asking oneself "What is the goal of what I'm doing right now? What are the steps to that goal? Am I paying attention to each step?"). Research shows cueing and conducting executive reviews is associated with fewer functional limitations in individuals with TBI. This content-free cueing involving several daily reminders helps apply goal-oriented behaviors in daily life, leading to better emotional regulation and social functioning after brain injury.

Finally, attention training has also been shown to be effective in reducing function limitations in TBI. The n-back task in particular has been used to increase attentional control, inhibition, and working memory by training conscious and deliberate use of strategies to effectively allocate attentional resources and manage the rate of information received during task completion, with recent studies showing working memory interventions in general, and n-back training specifically, change neural pathways and improve attentional control. All three (GMT, content free-cuing, and the n-back task) can be implemented via mobile health technology, extending cognitive rehabilitation from the clinic to the home. Optimal rehabilitation also capitalizes on an individual's social support network, particularly relevant for successful reintegration after military service for Veterans with TBI and PTSD. The investigators have found links between Veterans' social support and improved treatment engagement, reduced violence, and reduced suicide risk.

Conditions

Traumatic Brain Injury (TBI); Posttraumatic Stress Disorder (PTSD)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CALM (Cognitive Apps for Life Management)

Group Type: EXPERIMENTAL

CALM (Cognitive Apps for Life Management)

Intervention Type: 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.

Psychoeducation

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Over age 18;
• Fluent and literate in English
• Able to provide voluntary, informed consent to participate.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Elbogen

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University School of Medicine

Durham, North Carolina, United States

Countries

United States

Central Contacts

Janequia Evans

Role: CONTACT

Phone: 19296607280

Email: janequia.evans@duke.edu

Facility Contacts

Eric Elbogen

Role: primary

Other Identifiers

Pro00118644

Identifier Type: -

Identifier Source: org_study_id