Design of a randomized controlled trial of cognitive rehabilitation to reduce anger among veterans with traumatic brain injury and posttraumatic stress disorder: The CALM study protocol.
Abstract
Background
Traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) affect nearly one quarter of the veterans who served on or after September 11, 2001. Comorbid TBI + PTSD often results in significant executive dysfunction, including disinhibition, emotion dysregulation, anger, aggression, suicidal ideation, and impaired social functioning. Cognitive rehabilitation interventions can be effective at enhancing symptoms and functioning for veterans with TBI + PTSD, but several limitations need to be addressed.
Methods
One hundred veteran-support person dyads will be block-randomized to either (1) Cognitive Applications for Life Management (CALM), a mobile cognitive rehabilitation intervention involving goal management training plus cueing and attention training control, or (2) a mobile psychoeducational active control. Both conditions leverage the social support of a veteran's trusted family member or friend. Primary outcomes will assess comparative effects on anger dysregulation, impulsivity, and executive dysfunction. Exploratory outcomes include social and adaptive functioning, PTSD symptoms, and suicidal ideation. The study site and an independent Data and Safety Monitoring Board will monitor trial progress, safety, and quality. De-identified data from consenting participants will be submitted to a sponsor-designated data repository.
Conclusion
If successful, this trial will identify a relatively low-burden approach to treating anger, impulsivity, and other clinical symptoms among veterans with TBI + PTSD. Positive findings would also lay groundwork for testing CALM in active-duty military populations. This study was registered in ClinicalTrials.gov (NCT07227987).