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JMIR research protocols
Par Nakamura H, Okawa S, Tanoue H et 3 autres.
Contenu en anglais
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Young adult caregivers of a family member with major depressive disorder (MDD) constitute a vulnerable population. They have substantial support needs because they often experience psychological distress and daily burdens during a developmental period in which education, partnership formation, and parenting frequently overlap with caregiving responsibilities. Consequently, the burden associated with caring for a family member with MDD may adversely affect young adult caregivers' mental health and life stability. Despite these needs, support programs and intervention studies specifically targeting young adult caregivers remain scarce. Videoconference-based family psychoeducation (vFPE) may help address this gap, improving access for individuals facing time and geographic barriers. However, the feasibility of conducting a randomized controlled trial (RCT) of vFPE in this population has not yet been established.
The objective of this study is to examine the feasibility of conducting a waitlist-controlled pilot RCT of vFPE and the acceptability of the vFPE intervention among young adult caregivers of a family member with MDD.
This study is a waitlist-controlled pilot RCT. Young adult caregivers (aged 18-39 y) will be randomly assigned in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in the intervention group will receive 4 weekly 40-minute vFPE sessions. The primary outcomes are feasibility and acceptability. Feasibility will be assessed by recruitment, randomization, intervention completion, dropout rates, and safety. Acceptability will be assessed using the Client Satisfaction Questionnaire-8 Japanese version. Exploratory outcomes, including anxiety and depressive symptoms, mental well-being, psychological distress, caregiver burden, self-efficacy, and health-related quality of life, will be assessed at baseline, postintervention, and 1-month follow-up via online self-administered questionnaires. Exploratory outcomes will be used to inform the design of a future definitive RCT rather than to draw conclusions about intervention effectiveness.
This paper describes the study protocol. Ethical approval was obtained from the Research Ethics Committee, Faculty of Nursing, Toho University, on December 18, 2025. Recruitment commenced on January 10, 2026, with the first participant enrolled on February 20, 2026. As of May 2026, 8 participants had been enrolled. Intervention delivery and data collection are expected to continue until March 2028. Study findings will be disseminated through presentations at academic conferences and publication in peer-reviewed journals.
This study will clarify the feasibility of conducting an RCT of vFPE among young adult caregivers of a family member with MDD, providing foundational data to inform the design of a future definitive RCT.
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