| Summary: | Background: Globally, traumatic brain injury (TBI) is recognized as one of the most significant contributors to mortality and disability. Most of the patients who have experienced TBI will be discharged home and reunited with their families or primary caregivers. The degree of severity of their reliance on caregivers varies. Therefore, the task of delivering essential care to the patients becomes demanding for the caregivers. A significant proportion of caregivers expressed considerable burden, distress, and discontentment with their lives. Therefore, it is critical to comprehend the dynamic of TBI and caregivers to optimize patient care, rehabilitation, and administration. The effectiveness of the Brain Injury Family Intervention (BIFI) program tailored for caregivers of patients with TBI has been widely proven in Western countries. However, the impact is less clear among caregivers of patients with TBI in Malaysia. Objective: This study aims to assess the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of caregivers of patients with TBI at government hospitals in Malaysia. Methods: This is a 2-arm, single -blinded, randomized controlled trial. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. In total, 100 caregivers of patients with TBI attending the neurorehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program, whereas the control group will receive standard treatment. Caregivers aged >= 18 years, caring for patients who have completed >3 months after the injury, are eligible to participate. The BIFI program will be scheduled for 5 sessions as recommended by the developer of the module. Each session will take approximately 90 to 120 minutes. The participants are required to attend all 5 sessions. A total of 5 weeks is needed for each group to complete the program. Self -reported questionnaires (ie, Beck Depression Inventory, Positive and Negative Affect Schedule, Caregiver Strain Index, Satisfaction With Life Scale, and Family Needs Questionnaire) will be collected at baseline, immediately after the intervention program, at 3 -month follow-up, and at 6 -month follow-up. The primary end point is the caregivers' emotional distress. Results: The participant recruitment process began in January 2019 and was completed in December 2020. In total, 100 participants were enrolled in this study, of whom 70 (70%) caregivers are women and 30 (30%) are men. We are currently at the final stage of data analysis. The results of this study are expected to be published in 2024. Ethics approval has been obtained. Conclusions: It is expected that the psychological well-being of the intervention group will be better compared with that of the control group after the intervention at 3-month follow-up and at 6-month follow-up.
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