Type 1 Diabetes and Diabetes Distress

Официальное название

A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress

Обзор

The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes. The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care. The main research questions are: * Does a group-based psychological intervention reduce diabetes distress? * Does a group-based psychological intervention improve psychological well-being and glycemic outcomes? Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2). Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.

Вмешательства

• Поведенческое ACTnow
  The group-based psychological intervention consists of six bi-weekly sessions, each lasting two hours, with 6-10 participants per group, led by a psychologist and nurse. The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach shown to be effective for chronic diseases, with additional elements from cognitive behavioral therapy and health education. It is manual-based, developed by experienced clinicians at SDCO, and includes tools from an existing diabet

Первичные конечные точки

• Change in diabetes distress score using T1-DDS [Срок оценки: from baseline to 3 months]

Вторичные конечные точки (5)

• Change in the T1-DDAS score [Срок оценки: from baseline to 3 months]
• Change in AADQ score [Срок оценки: from baseline to 3 months]
• Change in GAD-7 score [Срок оценки: from baseline to 3 months]
• Change in HbA1c [Срок оценки: from baseline to 3 months]
• Change in PHQ-9 score [Срок оценки: from baseline to 3 months]

Критерии участия

Критерии включения

• Type 1 diabetes for at least 6 months
• Age between 18 and 35
• T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2
• Treated in a diabetes clinic in the Region of Southern Denmark
• Proficient in Danish

Критерии исключения

• Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention
• Cognitive disorders such as brain injury
• Complex challenges best suited to individual treatment
• Current therapeutic treatment for depression, anxiety or stress
• Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period

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

Открытое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• Esbjerg Hospital — Esbjerg
• Odense University Hospital — Odense
• Sønderborg Hospital — Sønderborg

Идентификаторы

NCT: NCT06936280 · 25/13117 · 25/13117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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