Effects of a narrative-based psychoeducational intervention on medication adherence in individuals with schizophrenia: a multicentre, parallel-group randomised controlled trial.

Background: 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. Methods: 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. Findings: 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). Interpretation: 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. Funding: 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.