Adapted Mindfulness Training for Diabetic Patients With Impaired Hypoglycemia Awareness

Официальное название

Impact of Adapted Mindfulness Training Integrating Interoception on Diabetic Patients With Impaired Awareness of Hypoglycemia: A Randomized Controlled Trial

Обзор

The purpose of this randomized controlled trial is to evaluate the effectiveness of an 8-week interoception-integrated adapted mindfulness training program for patients with type 1 or type 2 diabetes who experience impaired awareness of hypoglycemia (IAH). The study aims to determine whether this mindfulness intervention, which includes techniques such as body scanning and mindful eating, can help patients better recognize early physiological signals of low blood sugar compared to routine care. Researchers will measure changes in participants' interoceptive awareness and the severity of their IAH over a 3-month follow-up period. The ultimate goal is to provide a practical psychological approach to improve symptom perception and reduce the risk of severe hypoglycemic events in diabetic patients.

Подробное описание

Diabetic patients are prone to hypoglycemia during insulin therapy, and repeated episodes can lead to impaired awareness of hypoglycemia (IAH), significantly increasing the incidence of severe hypoglycemia and adverse health outcomes. Recent studies indicate that altered interoceptive awareness is closely associated with an increased risk of IAH, and mindfulness interventions can effectively enhance an individual's interoceptive awareness. This study aims to explore the effects of an interoception-integrated adapted mindfulness training program on interoceptive awareness and impaired awareness of hypoglycemia in diabetic patients. This study is a two-arm, parallel-group randomized controlled trial. It plans to recruit 100 type 1 or type 2 diabetic patients with IAH who meet the eligibility criteria (e.g., Gold score ≥ 4 and Clarke score ≥ 4) from two community health centers in Yangzhou. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=50) or the control group (n=50). The control group will receive routine treatment, examinations, nursing care, and health education. On this basis, the intervention group will receive an 8-week interoception-integrated adapted mindfulness training program, conducted once a week (1-1.5 hours per session). Based on Mindfulness-Based Stress Reduction (MBSR), the program utilizes core techniques such as body scanning, mindful eating, and mindful walking to reinforce patients' perception and awareness of early physiological signals of hypoglycemia, supplemented by daily home practices. Primary outcomes are the patients' interoceptive awareness (assessed by the MAIA-2 scale) and the severity of impaired awareness of hypoglycemia (evaluated by the Clarke and Gold questionnaires). Secondary outcomes include mindfulness levels (FFMQ) and negative cognitive processing bias (NCPBQ). Data collection time points are set at pre-intervention (T0), immediately post-intervention (T1), 1 month post-intervention (T2), and 3 months post-intervention (T3). Statistical analyses will employ descriptive statistics, univariate analysis, and Generalized Estimating Equations (GEE) to evaluate the intervention effects. This study is expected to provide a practical psychological intervention to improve symptom perception in diabetic patients with IAH, thereby reducing the incidence of severe hypoglycemia and improving clinical outcomes.

Вмешательства

• Поведенческое Adapted Mindfulness Training
  An 8-week adapted mindfulness program, based on Mindfulness-Based Stress Reduction (MBSR), is delivered to patients with Impaired Awareness of Hypoglycemia (IAH) by a multidisciplinary team. It involves weekly 1-1.5 hour face-to-face group sessions (8-10 participants) and daily home practices supervised via a WeChat group. Tailored to IAH, the curriculum integrates core skills (mindful meditation, yoga, breathing, and walking) with IAH-specific elements. By training self-awareness, attentional c
• Поведенческое Routine Intervention
  The control group receives routine medical care, examinations, nursing, and health education. While they undergo the same follow-up schedule as the intervention group, no mindfulness practice guidance is provided during the study period. Upon the conclusion of the study, mindfulness-related materials will be distributed to these participants.

Первичные конечные точки

• Clark Score [Срок оценки: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention]
• Gold Score [Срок оценки: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention]
• Multidimensional Assessment of Interoceptive Awareness Version 2 [Срок оценки: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention]

Вторичные конечные точки (2)

• Five Facet Mindfulness [Срок оценки: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention]
• Negative Cognitive Processing Bias Questionnaire [Срок оценки: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention]

Критерии участия

Критерии включения

• Diagnosed with type 1 or type 2 diabetes mellitus according to the latest American Diabetes Association (ADA) Standards of Care in Diabetes;
• Receiving insulin therapy for ≥ 1 year;
• Age between 18 and 80 years (inclusive);
• Duration of diabetes ≥ 5 years;
• Gold score ≥ 4 and Clarke score ≥ 4;
• Voluntary participation and provision of signed informed consent.

Критерии исключения

• Prior experience with mindfulness interventions;
• Diagnosed with cognitive impairment, psychiatric disorders, or other severe physical comorbidities;
• Current use of psychotropic medications;
• Pregnant or lactating women, or women of childbearing potential not using effective contraception.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07586527 · YZUHL20250040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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