Liu Zhao, Zhu Dian, Zhang Zhiwen, Liu Yanli, Yang Hongyi, Chang Fangyuan, Zhang Weibo, Cai Jun
School of Design, Shanghai Jiao Tong University, Shanghai, 200240, PR China.
Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
EClinicalMedicine. 2025 Sep 4;88:103483. doi: 10.1016/j.eclinm.2025.103483. eCollection 2025 Oct.
Medication non-adherence is a significant challenge in the management of schizophrenia, with non-adherence rates ranging from 30 to 70%. Digital interventions may address barriers to adherence and improve outcomes. We aimed to evaluate the efficacy of a narrative-based psychoeducational intervention in improving medication adherence, attitudes, psychological state, and quality of life in individuals with stable schizophrenia.
This multicentre, parallel-group randomised controlled trial with blinded outcome assessment was conducted at seven community rehabilitation centres. Eligible patients (aged 18-60 years) had a diagnosis of schizophrenia (ICD-10) in a clinically stable phase, had normal vision and hearing, and were able to use a smartphone independently. Upon enrolment, participants were randomly allocated (1:1) to either the intervention group or the control group. The intervention group received standard community rehabilitation plus a narrative-based psychoeducational intervention three times per week for 3 months, while the control group received standard community rehabilitation only. Co-primary outcomes were medication adherence and medication attitude, as assessed using validated self-report questionnaires: the Morisky Medication Adherence Scale-8 (MMAS-8) and the Drug Attitude Inventory (DAI-10), respectively, at: baseline (T0, prior to randomization), post-intervention (T1, after 3 months of intervention), 1-month follow-up (T2, 4 months from baseline), and 3-month follow-up (T3, 6 months from baseline). This trial is registered with ClinicalTrials.gov, NCT06175559.
Between Feb 1 and March 25, 2024, 72 participants were enrolled. Two participants withdrew (distance concerns). Data collection continued until October 30, 2024. Among the 70 participants who completed assessments (mean [SD] age, 44.20 [8.06] years; 27 women [38.57%], 43 men [61.43%]), significant between-group differences emerged over time. The psychoeducational intervention group reported greater positive changes than the control group in medication adherence (β = 0.75 [95% CI, 0.10-1.40]; P = 0.02) and medication attitude (β = 2.29 [0.42-4.15]; P = 0.02) at the T1, and the difference was sustained at 3-month follow-up for adherence (β = 1.65 [0.68-2.62]; P < 0.001) and attitude (β = 3.42 [1.38-5.45]; P = 0.001). Older patients showed significantly better outcomes in medication attitudes (β = 1.56 [0.03-3.10]; P = 0.05) and clinical symptoms (β = -2.43 [-4.83 to -0.04]; P = 0.05), while those with lower education levels had significantly better medication adherence (β = 0.93 [0.20-1.67]; P = 0.01) and social relationships (β = 0.87 [0.23-1.52]; P = 0.01).
Our findings suggest that narrative-based psychoeducational interventions can improve medication adherence in individuals with schizophrenia, with sustained effects. Future studies should investigate the long-term effectiveness and implementation of narrative-based psychoeducation interventions in larger and more diverse patient populations.
Shanghai Municipal Science and Technology Commission 2024 "Science and Technology Innovation Action Plan" Medical Innovation Research Field Program, the Shanghai Municipal Education Commission, Shanghai Jiao Tong University 2024 Medical-Industrial Intersection Research Fund, and Shanghai Jiao Tong University Medical-Industrial Interdisciplinary Youth Program.
药物治疗不依从是精神分裂症管理中的一项重大挑战，不依从率在30%至70%之间。数字干预可能有助于克服依从性障碍并改善治疗效果。我们旨在评估基于叙事的心理教育干预对改善稳定期精神分裂症患者的药物依从性、态度、心理状态和生活质量的效果。
这项多中心、平行组随机对照试验在七个社区康复中心进行，采用盲法评估结果。符合条件的患者（年龄18 - 60岁）处于精神分裂症（ICD - 10）临床稳定期，视力和听力正常，能够独立使用智能手机。入组后，参与者被随机分配（1:1）到干预组或对照组。干预组接受标准社区康复治疗，并每周接受三次基于叙事的心理教育干预，为期3个月，而对照组仅接受标准社区康复治疗。共同主要结局是药物依从性和药物态度，分别使用经过验证的自我报告问卷进行评估：Morisky药物依从性量表 - 8（MMAS - 8）和药物态度量表（DAI - 10），评估时间为：基线（T0，随机分组前）、干预后（T1，干预3个月后）、1个月随访（T2，基线后4个月）和3个月随访（T3，基线后6个月）。本试验已在ClinicalTrials.gov注册，注册号为NCT06175559。
在2024年2月1日至3月25日期间，共招募了72名参与者。两名参与者因距离问题退出。数据收集持续到2024年10月30日。在完成评估的70名参与者中（平均[标准差]年龄为44.20[8.06]岁；女性27名[38.57%]，男性43名[61.43%]），随着时间推移，组间出现了显著差异。心理教育干预组在T1时的药物依从性（β = 0.75[95%CI，0.10 - 1.40]；P = 0.02）和药物态度（β = 2.29[0.42 - 4.15]；P = 0.02）方面比对照组报告了更大的积极变化，并且在3个月随访时，依从性（β = 1.65[0.68 - 2.62]；P < 0.001）和态度（β = 3.42[1.38 - 5.45]；P = 0.001）的差异仍然存在。年龄较大的患者在药物态度（β = 1.56[0.03 - 3.10]；P = 0.05）和临床症状（β = -2.43[-4.83至 -0.04]；P = 0.05）方面表现出显著更好的结果，而教育水平较低的患者在药物依从性（β = 0.93[0.20 - 1.67]；P = 0.01）和社会关系（β = 0.87[0.23 - 1.52]；P = 0.01）方面表现出显著更好的结果。
我们的研究结果表明，基于叙事的心理教育干预可以改善精神分裂症患者的药物依从性，并具有持续效果。未来的研究应在更大且更多样化的患者群体中调查基于叙事的心理教育干预的长期有效性和实施情况。
上海市科学技术委员会2024年“科技创新行动计划”医学创新研究领域项目、上海市教育委员会、上海交通大学2024年医工交叉研究基金以及上海交通大学医工交叉青年项目。
