Ageonomori Clinic, Ageo, Saitama, Japan.
Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan.
BMC Psychiatry. 2024 Jun 14;24(1):445. doi: 10.1186/s12888-024-05884-z.
The purpose of this study was to examine the effects of a brief family psychoeducation (BFP) programme provided by psychiatric visiting nurses on caregiver burden of family caregivers of people with schizophrenia through a cluster randomised controlled trial (cRCT).
The study was a two-arm, parallel-group cRCT. Forty-seven psychiatric visiting nurse agencies were randomly allocated to the BFP programme group (intervention group) or treatment as usual group (TAU; control group). Caregivers of people with schizophrenia were recruited by psychiatric visiting nurses using a randomly ordered list. The primary outcome was caregiver burden, measured using the Japanese version of the Zarit Burden Interview. Outcome assessments were conducted at baseline, 1-month follow-up, and 6-month follow-up. Intention-to-treat analysis was conducted to examine the effects of the BFP programme on caregiver burden.
Thirty-four psychiatric visiting nurse agencies and 83 family caregivers of people with schizophrenia participated in the study. The participant attrition rate was less than 20%. Adherence to the program was 100%. Compared with TAU group, the BFP programme group had decreased caregiver burden. However, this improvement was not significant at 1-month follow-up (adjusted mean difference [aMD] = 0.27, 95% CI = - 5.48 to 6.03, p = 0.93, d = 0.01) or 6-month follow-up (aMD = - 2.12, 95% CI = - 7.80 to 3.56, p = 0.45, d = 0.11).
The BFP programme provided by psychiatric visiting nurses did not achieve significant decreases in caregiver burden. This result may be attributed to the difficulty in continuing the research due to the COVID-19 pandemic, which prevented us from achieving the targeted sample size necessary to meet the statistical power requirements, as well as to the participation of caregivers with relatively low burden. However, the program had the advantage of high adherence to treatment plan. Further studies should be conducted with a larger sample size and a more diverse sample that includes caregivers with a higher care burden.
The study protocol was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000038044) on 2019/09/18.
本研究旨在通过一项整群随机对照试验(cRCT),检验精神科家访护士提供的简短家庭心理教育(BFP)方案对精神分裂症患者家庭照顾者的照顾者负担的影响。
该研究为两臂平行组 cRCT。47 家精神科家访护士机构被随机分配到 BFP 方案组(干预组)或常规治疗组(TAU;对照组)。精神科家访护士通过随机顺序列表招募精神分裂症患者的照顾者。主要结局指标是照顾者负担,使用日本版 Zarit 负担量表进行评估。在基线、1 个月随访和 6 个月随访时进行结局评估。意向治疗分析用于检验 BFP 方案对照顾者负担的影响。
34 家精神科家访护士机构和 83 名精神分裂症患者的家庭照顾者参加了研究。参与者的失访率低于 20%。对方案的依从性为 100%。与 TAU 组相比,BFP 方案组的照顾者负担降低。然而,这种改善在 1 个月随访时并不显著(调整后的平均差异[aMD]=0.27,95%CI=-5.48 至 6.03,p=0.93,d=0.01)或 6 个月随访时也不显著(aMD=-2.12,95%CI=-7.80 至 3.56,p=0.45,d=0.11)。
精神科家访护士提供的 BFP 方案并未显著降低照顾者负担。这一结果可能归因于 COVID-19 大流行导致研究难以继续,这使得我们无法达到满足统计功效要求所需的目标样本量,以及照顾者负担相对较低的原因。然而,该方案具有治疗计划高依从性的优势。应进行进一步的研究,纳入更大的样本量和更多包括负担较重的照顾者在内的多样化样本。
研究方案于 2019 年 9 月 18 日在大学医院医疗信息网络临床试验注册处(UMIN000038044)注册。