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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HypnoDiaCare | Experimental | integrative hypnosis-based diabetes self-management intervention |
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| EduDiaCare | Active Comparator | education-only AADE7-based diabetes self-management sessions |
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| Neutral Visual Attention Control | Sham Comparator | neutral visual exposure using standardized non-emotional OASIS images |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Posttest 1 (~1-2 weeks) |
| Anxiety Symptoms (DASS-42 Anxiety Subscale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwartarini Wahyu Yuniarti, Professor / Ph.D | Gadjah Mada University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypnotic Guided Imagery Laboratory, Faculty of Psychology, Universitas Gadjah Mada | Yogyakarta | 55281 | Indonesia |
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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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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A three-arm, parallel-group randomized controlled trial with pretest-posttest assessments and a delayed-intervention design for the control group.
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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.
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| 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. |
|
| 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. |
|
Assessed using the Anxiety subscale of the DASS-42. Higher scores indicate greater anxiety symptoms. |
| 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. | 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. | Baseline to Posttest 1 (~1-2 weeks) |
| D004700 | Endocrine System Diseases |