The TBI-AD/ADRD Caregiver Support Intervention (TACSI): Protocol of a Pilot-RCT Evaluation of a Remote Intervention for Family Caregivers (Preprint)

BACKGROUND Across the United States, there are millions of informal (i.e. unpaid) caregivers helping individuals with Alzheimer’s Disease/Alzheimer’s Disease and Related Dementias (AD/ADRD), traumatic brain injury (TBI), or both. TBI is a risk factor for developing, and often co-occurs with, AD/ADRD. In the next decade, more informal caregivers will have to navigate the complexities of the dual diagnosis of TBI and AD/ADRD. Currently, there is a paucity of interventions for caregivers dealing with this dual diagnosis. Our team designed the TBI-AD/ADRD Caregiver Support Intervention (TACSI) as a support program to meet the needs of those providing care to individuals with dual diagnoses of TBI and AD/ADRD. OBJECTIVE This pilot randomized controlled trial (RCT) evaluates the preliminary efficacy and successful implementation of TACSI, a 6-session semi-structured psychosocial and psychoeducational program, over a 6-month period. METHODS This pilot RCT employs an embedded mixed methods randomized controlled evaluation. Caregivers of individuals with a dual diagnosis of AD/ADRD and a history of TBI are randomly assigned to the TACSI (n=41) or a usual care control condition (n=39). Primary outcomes include perceived burden, caregiver relationship satisfaction, and caregiving mastery. Secondary outcomes include caregiver self-efficacy, well-being, and personal resources. Qualitative elements (up to 20 semi-structured interviews at the conclusion of the 6-month evaluation and an open-response item at follow-up surveys) allow for better interpretation of quantitative results and understanding of TACSI’s mechanisms of benefit. RESULTS Recruitment for the study was completed October 2024. Survey collection and intervention was completed June 2025. Data analysis will follow. CONCLUSIONS Having a dual diagnosis of AD/ADRD and a history of TBI is relatively common. However, there are currently no caregiver support interventions specific to this dual diagnosis. It is important to support these caregivers as they encounter the unique challenges of managing TBI and AD/ADRD. This pilot RCT will help determine if the TACSI program can help to increase caregiving skills and strategies and provide support to improve mood and reduce stress for caregivers of individuals with AD/ADRD and a history of TBI, and also is feasible to proceed to a full-scale RCT. CLINICALTRIAL Clinical Trials NCT05465109; https://clinicaltrials.gov/study/NCT05465109