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.