Cognitive Rehabilitation for Treatment of Anger in Veterans With TBI and PTSD
Purpose
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)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participant dyads will be randomized to either Cognitive Rehabilitation (n=50) or Psychoeducation (n=50).
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CALM (Cognitive Apps for Life Management) |
|
|
|
Active Comparator Psychoeducation |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Duke University
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.
