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
Tanve Garg, Vishal Dhiman, Anindya Das, Naveen GroverABSTRACT
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 (
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