CompletedNot Applicable

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

Indonesia54 participantsStarted 2024-12-23

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diabetes Self-Management (IDN-DSMI Total Score)

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

Quality of Life (WHOQOL-BREF)

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

Trial details

NCT IDNCT07279779

SponsorGadjah Mada University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials