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HypnoDiaCare Trial: A Randomized Controlled Study of Hypnosis-Integrated Diabetes Self-Management Intervention

NCT07279779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-12

No results posted yet for this study

Summary

This study evaluated the efficacy of HypnoDiaCare, a two-session integrative intervention that combines clinical hypnosis with diabetes self-management education based on the AADE7 Self-Care Behaviors framework, for adults with type 2 diabetes mellitus (T2DM). The trial used a three-arm randomized controlled design with HypnoDiaCare, EduDiaCare (education-only), and a neutral visual attention control group. All participants completed two individual sessions over a 1-2-week interval and completed pretest and posttest assessments.

HypnoDiaCare integrates hypnotic induction, guided imagery, ego strengthening, and positive suggestions with diabetes self-management principles. EduDiaCare provides structured education without hypnosis, and the control group viewed neutral images designed to maintain stable emotional and physiological states.

After the initial posttest, control-group participants were re-randomized to receive HypnoDiaCare or EduDiaCare to explore delayed-intervention effects. Primary outcomes were diabetes self-management and quality of life, while secondary outcomes included psychological symptoms and affective states.

The study aims to determine whether HypnoDiaCare produces greater improvements in self-management and quality of life compared with education-only and attention-control conditions.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

BEHAVIORAL

HypnoDiaCare

A two-session individualized behavioral intervention integrating clinical hypnosis with diabetes self-management education. The protocol includes hypnotic induction, deepening, guided imagery, therapeutic suggestion, ego strengthening, and post-hypnotic suggestions, with AADE7 self-care principles embedded within the suggestion phases.

BEHAVIORAL

EduDiaCare

A structured two-session diabetes self-management education program based on the AADE7 Self-Care Behaviors framework, covering healthy eating, physical activity, medication adherence, glucose monitoring, emotional coping, decision making, and problem solving. Delivered without hypnosis.

OTHER

Neutral Visual Exposure

A two-session presentation of standardized neutral-valence, low-arousal images from the OASIS database. Images are displayed for brief intervals to control for attention and expectancy effects without educational or therapeutic content.

Sponsors & Collaborators

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • Kwartarini Wahyu Yuniarti, Professor / Ph.D · Gadjah Mada University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279779 on ClinicalTrials.gov