Type 2 Diabetes Mellitus (T2DM)HDC-RCTNCT07279779
HypnoDiaCare Trial: A Randomized Controlled Study of Hypnosis-Integrated Diabetes Self-Management Intervention
A study testing HypnoDiaCare, EduDiaCare and Neutral Visual Exposure in people with Type 2 Diabetes Mellitus (T2DM), run by Gadjah Mada University at 1 site in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- HypnoDiaCare, EduDiaCare and Neutral Visual Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Dec 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hypnotic Guided Imagery Laboratory, Faculty of Psychology, Universitas Gadjah Mada
Yogyakarta, 55281
About this study
Official title: 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 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.
Read more
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.
Read the detailed description
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.
No investigational drugs or devices were used. The study received ethical approval from the Ethics Committee of the Faculty of Psychology, Universitas Gadjah Mada. All procedures were conducted in accordance with ethical standards for research involving human participants.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- HypnoDiaCare, EduDiaCare, Neutral Visual Exposure
- Keywords
- Hypnosis, Clinical Hypnosis, Diabetes Self-Management, AADE7 Self-Care Behaviors, Type 2 Diabetes Mellitus, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoDiaCareBehavioural
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.
EduDiaCareBehavioural
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.
Neutral Visual ExposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HypnoDiaCare | Experimental | integrative hypnosis-based diabetes self-management intervention Receives: Behavioral: HypnoDiaCare |
| EduDiaCare | Active comparator | education-only AADE7-based diabetes self-management sessions Receives: Behavioral: EduDiaCare |
| Neutral Visual Attention Control | Sham comparator | neutral visual exposure using standardized non-emotional OASIS images Receives: Other: Neutral Visual Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks
Secondary outcomes (4)
Depression Symptoms (DASS-42 Depression Subscale)
Assessed using the Depression subscale of the DASS-42, consisting of 14 items rated on a 4-point scale. Higher scores indicate greater depressive symptoms.
Measured: Baseline to Posttest 1 (~1-2 weeks)
Anxiety Symptoms (DASS-42 Anxiety Subscale)
Assessed using the Anxiety subscale of the DASS-42. Higher scores indicate greater anxiety symptoms.
Measured: Baseline to Posttest 1 (~1-2 weeks)
Stress Symptoms (DASS-42 Stress Subscale)
Measured using the General Positive Affect (GPA) composite from the PANAS-X. Higher scores reflect higher positive affect.
Measured: Baseline to Posttest 1 (~1-2 weeks)
Negative Affect (PANAS-X General Negative Affect Score)
Measured using the General Negative Affect (GNA) composite from the PANAS-X. Higher scores reflect higher negative affect.
Measured: Baseline to Posttest 1 (~1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start23 Dec 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-arm, parallel-group randomized controlled trial with pretest-posttest assessments and a delayed-intervention design for the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martaria Rizky Rinaldi, Gadjah Mada University
- Investigators
- Kwartarini Wahyu Yuniarti, Professor / Ph.D, Study chair, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279779
- Sponsor's protocol ID
- UGM-PSI-HYPNODIACARE
- Acronym
- HDC-RCT
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been finalized. De-identified data may be shared upon reasonable request after primary analyses and publications are completed, subject to ethics approval and data-sharing agreements. No IPD will be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07279779
- Acronym / sponsor ID
- HDC-RCT / UGM-PSI-HYPNODIACARE
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
No investigational drugs or devices were used. The study received ethical approval from the Ethics Committee of the Faculty of Psychology, Universitas Gadjah Mada. All procedures were conducted in accordance with ethical standards for research involving human participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A three-arm, parallel-group randomized controlled trial with pretest-posttest assessments and a delayed-intervention design for the control group.
| Arm | Type | Receives |
|---|---|---|
| HypnoDiaCare | Experimental | Behavioral: HypnoDiaCareintegrative hypnosis-based diabetes self-management intervention |
| EduDiaCare | Active comparator | Behavioral: EduDiaCareeducation-only AADE7-based diabetes self-management sessions |
| Neutral Visual Attention Control | Sham comparator | Other: Neutral Visual Exposureneutral visual exposure using standardized non-emotional OASIS images |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnoDiaCareA 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. | Behavioural | HypnoDiaCare |
| EduDiaCareA 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. | Behavioural | EduDiaCare |
| Neutral Visual ExposureA 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. | Other | Neutral Visual Attention Control |
Primary outcome
Diabetes Self-Management (IDN-DSMI Total Score)
Time frame: Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks
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.
Quality of Life (WHOQOL-BREF)
Time frame: Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks
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.
4 secondary outcomes
Depression Symptoms (DASS-42 Depression Subscale)
Time frame: Baseline to Posttest 1 (~1-2 weeks)
Anxiety Symptoms (DASS-42 Anxiety Subscale)
Time frame: Baseline to Posttest 1 (~1-2 weeks)
Stress Symptoms (DASS-42 Stress Subscale)
Time frame: Baseline to Posttest 1 (~1-2 weeks)
Negative Affect (PANAS-X General Negative Affect Score)
Time frame: Baseline to Posttest 1 (~1-2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been finalized. De-identified data may be shared upon reasonable request after primary analyses and publications are completed, subject to ethics approval and data-sharing agreements. No IPD will be shared at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwartarini Wahyu Yuniarti, Professor / Ph.D study chair
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoDiaCare, EduDiaCare and Neutral Visual Exposure in people with Type 2 Diabetes Mellitus (T2DM), run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management (IDN-DSMI Total Score) (time frame: Baseline (pretest) to Posttest 1 (after Session 2), approximately 1-2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.