A Three-Arm Randomized Controlled Trial Evaluating the Efficacy of HypnoDiaCare, an Integrative Hypnosis-Based Diabetes Self-Management Intervention, Compared With EduDiaCare and Neutral Visual Attention Control Among Adults With Type 2 Diabetes Mellitus

This study is a three-arm, pretest-posttest, single-blind randomized controlled trial designed to examine the efficacy of HypnoDiaCare, an integrative intervention combining clinical hypnosis techniques with diabetes self-management education for adults with type 2 diabetes mellitus (T2DM). The trial compared HypnoDiaCare with two comparator conditions: (1) EduDiaCare, a structured education-only program based on the AADE7 Self-Care Behaviors framework, and (2) a neutral visual attention control condition.

Participants were recruited through community health centers (Puskesmas) and social media platforms from December 2024 to March 2025. Eligible participants were adults aged 20 years or older with a documented or self-reported diagnosis of T2DM, able to read Indonesian, and not currently undergoing psychological therapy or experiencing severe psychiatric conditions. All participants provided written informed consent.

Randomization was conducted individually using simple randomization procedures. The study employed a single-blind design in which participants were unaware of the specific nature of the intervention they received. Interventions were delivered individually by trained clinical psychologists following standardized manuals to ensure protocol fidelity.

The HypnoDiaCare intervention consisted of two sessions: a 90-120-minute first session and a 60-minute second session. The structure followed established stages of clinical hypnosis, including induction, deepening, therapeutic imagery, ego strengthening, and post-hypnotic suggestions. Diabetes self-management principles were embedded within the therapeutic suggestion phases. EduDiaCare comprised two 60-minute sessions of individualized diabetes self-management education covering healthy eating, physical activity, medication adherence, glucose monitoring, emotional coping, problem solving, and decision making. The control group received two sessions of neutral visual exposure using standardized affectively neutral images designed to control for attention and expectancy effects.

Primary outcomes were diabetes self-management, assessed using the Indonesian version of the Diabetes Self-Management Instrument (IDN-DSMI), and quality of life measured using the WHOQOL-BREF. Secondary outcomes included depression, anxiety, and stress (DASS-42), as well as affective states measured by the Positive and Negative Affect Schedule - Expanded Form (PANAS-X). Assessments were completed at baseline (pretest) and after the second session (posttest 1). Participants in the control group who later received HypnoDiaCare or EduDiaCare underwent additional pre- and post-intervention assessments for exploratory analysis.