Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 16, 2023
Date Accepted: Feb 7, 2024
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The Effectiveness of Brain Injury Family Intervention (BIFI) in Improving Psychological Well-being of Traumatic Brain Injury (TBI) Caregivers: Study Protocol for a Randomized Controlled Trial.
ABSTRACT
Background:
The effectiveness of the Brain Injury Family Intervention (BIFI) program tailored for Traumatic Brain Injury (TBI) caregivers has been widely proven in Western countries. However, the impact is less clear among TBI caregivers in Malaysia. This study protocol describes the measurement of the effectiveness of BIFI in reducing emotional distress and burden of care, fulfilling the needs, and increasing the life satisfaction of TBI caregivers at government hospitals.
Objective:
This study aims to assess the effectiveness of BIFI in terms of reducing emotional distress and burden of care, besides fulfilling the needs and increasing the life satisfaction of TBI caregivers in selected hospitals.
Methods:
This is a two-armed, single-blinded randomized controlled trial study. It will be conducted at Hospital Rehabilitasi Cheras and Hospital Sungai Buloh. A total of 100 TBI caregivers attending the neuro-rehabilitation unit will be randomized equally to the intervention and control groups. The intervention group will undergo the BIFI program while the control group will receive standard treatment. TBI caregivers aged 18 and above, caring for patients who are more than 3 months post-injury are eligible to participate. The BIFI program will be scheduled for five sessions as recommended by the developer of the module. Each session will take about 90-120 minutes. The participants are required to attend all five sessions. A total of 5 weeks is needed for each group to complete the program. Self-reported questionnaires (i.e.; 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, 3-month, and 6-month follow-ups. The primary endpoint is the TBI caregivers’ emotional distress.
Results:
The participant recruitment process began in January 2019 and completed in December 2020.
Conclusions:
It is expected that the psychological well-being of the intervention group will be better compared to the control group at post-intervention, 3-month, and 6-month follow-ups. Clinical Trial: IRCT20180809040746N1
Citation
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Copyright
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