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

NCT07279779 | Completed

• 1 other identifier: UGM-PSI-HYPNODIACARE
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Hypnosis; Clinical Hypnosis; Diabetes Self-Management; AADE7 Self-Care Behaviors; Type 2 Diabetes Mellitus; Quality of Life; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Diabetes Self-Management (IDN-DSMI Total Score)

  Diabetes self-management will be assessed using the Indonesian version of the Diabetes Self-Management Instrument (IDN-DSMI), a validated 35-item self-report scale measuring self-integration, self-regulation, interaction with healthcare providers and significant others, glucose monitoring, and treatment adherence. Higher scores indicate better self-management.

  Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks

• Quality of Life (WHOQOL-BREF)

  Quality of life will be measured using the WHOQOL-BREF, a 26-item instrument assessing physical, psychological, social, and environmental domains. Scores are computed using the official WHO scoring method. Higher scores indicate better quality of life.

  Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks

Secondary Outcomes (4)

• Depression Symptoms (DASS-42 Depression Subscale)

  Baseline to Posttest 1 (~1-2 weeks)

• Anxiety Symptoms (DASS-42 Anxiety Subscale)

  Baseline to Posttest 1 (~1-2 weeks)

• Stress Symptoms (DASS-42 Stress Subscale)

  Baseline to Posttest 1 (~1-2 weeks)

• Negative Affect (PANAS-X General Negative Affect Score)

  Baseline to Posttest 1 (~1-2 weeks)

Study Arms (3)

HypnoDiaCare

EXPERIMENTAL

integrative hypnosis-based diabetes self-management intervention

Behavioral: HypnoDiaCare

EduDiaCare

ACTIVE COMPARATOR

education-only AADE7-based diabetes self-management sessions

Behavioral: EduDiaCare

Neutral Visual Attention Control

SHAM COMPARATOR

neutral visual exposure using standardized non-emotional OASIS images

Other: Neutral Visual Exposure

Interventions

HypnoDiaCare BEHAVIORAL

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.

HypnoDiaCare

EduDiaCare BEHAVIORAL

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.

EduDiaCare

Neutral Visual Exposure OTHER

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.

Neutral Visual Attention Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 years or older
• Diagnosed with type 2 diabetes mellitus (T2DM), confirmed via self-report or written recommendation from Puskesmas based on medical records
• Able to read and understand Indonesian
• Not currently receiving psychological therapy
• Willing to attend two intervention sessions
• Provided written informed consent

You may not qualify if:

• History of severe psychiatric disorders as self-reported
• Currently undergoing psychological treatment or psychotherapy
• Severe physical illness or comorbidities that may interfere with participation
• Cognitive impairment that may hinder comprehension or procedure adherence
• Failure to attend both intervention sessions
• Any condition judged by the investigators to interfere with safe participation

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Hypnotic Guided Imagery Laboratory, Faculty of Psychology, Universitas Gadjah Mada

Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kwartarini Wahyu Yuniarti, Professor / Ph.D

  Gadjah Mada University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to their group assignment and the specific nature of the intervention they received to minimize expectancy effects. Facilitators could not be blinded due to procedural differences across intervention arms. Outcomes assessors were not involved in intervention delivery and were partially unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A three-arm, parallel-group randomized controlled trial with pretest-posttest assessments and a delayed-intervention design for the control group.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: December 23, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

ID (1)