Single-blind, parallel-group randomized sham-controlled trial to evaluate the efficacy of a single-session Intervention for caregiver affiliate stigma REduction (i-CARE) in severe mental illnesses.

BACKGROUND: Affiliate stigma among caregivers of individuals with severe mental illnesses remains a significant yet underaddressed issue, with limited evidence from randomized controlled trials evaluating targeted stigma-reduction interventions. AIM: To evaluate the effectiveness of the Intervention for Caregiver Affiliate Stigma REduction (i-CARE) in reducing affiliate stigma among caregivers of individuals with severe mental illnesses (SMIs), compared with a time- and attention-matched sham intervention, using a randomized controlled design. METHODS: A single-center, randomized, single-blind, parallel-group superiority trial was conducted among 80 caregivers of individuals with SMIs, and 57 completed the 3-week follow-up assessment. The intervention group received i-CARE, a structured program targeting affiliate stigma. The control group received a sham intervention consisting of time-matched general interaction and clinical evaluation without stigma-focused components. Affiliate stigma was measured using the Affiliate Stigma Scale (ASS) at baseline and post intervention. RESULTS: Of the enrolled participants, 54 were allocated to the intervention group and 26 to the sham group. Intention-to-treat analysis using mixed-model ANOVA demonstrated a significant main effect of time and a significant time × intervention interaction (P < 0.001). The intervention group showed a significant reduction in ASS scores from 48.57 ± 14.52 to 42.56 ± 11.62 (P < 0.001), with a moderate effect size (0.44). Improvements were sustained at the 3-week follow-up. No adverse events were reported. CONCLUSIONS: i-CARE demonstrated promising short-term effectiveness in reducing affiliate stigma among caregivers of individuals with SMIs. However, longer-term evaluations are needed to develop interventions capable of producing more durable effects.Trial Registration: CTRI/2022/01/039333.