Short summary

The aim is to reduce diabetes distress and improve psychological well-being and glycemic outcomes, in adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress. The intervention is a group-based psychological intervention (ACTnow), led by nurses, psychologists and physicians, and is designed in a format that can easily be integrated into future standard care. The intervention group will be compared with a waitlist control group, receiving the intervention after 3 months.

Rationale

Objective This study aims to evaluate the effectiveness of a group-based psychological intervention in reducing diabetes distress among young adults (aged 18-35) with type 1 diabetes (T1D) and moderate to high levels of diabetes distress, using a randomized controlled trial (RCT) design. Background Diabetes distress refers to the emotional burden and concerns associated with managing diabetes. It negatively impacts quality of life, self-care behaviors, and glycemic control (HbA1c). An estimated 20-40% of individuals with T1D experience moderate to high diabetes distress, with the highest prevalence in young adults. A 2024 national Danish survey found that 38% of individuals aged 19-39 reported high diabetes distress. For young adults, distress is often linked to uncertainty about the future and frustration with complex treatment regimens. Although not classified as a psychiatric disorder, addressing the psychological impact of diabetes is crucial. Cognitive behavioral therapy (CBT)-based interventions tailored to diabetes have shown effectiveness in reducing distress, with group-based formats proving more beneficial than individual approaches. However, few studies have examined the impact of group-based interventions specifically for young adults with T1D, and evidence-based tools remain limited. Hypotheses Primary outcome: The intervention will significantly reduce diabetes distress. Secondary outcomes: Participants will show reduced concerns about diabetes technology, increased acceptance of diabetes-related thoughts and emotions, reduced anxiety and depression symptoms, and improved glycemic control (either increases or decreases in HbA1c depending on individual baseline levels).

Description of the cohort

18 - 35 year olds diagnosed with type 1 diabetes and moderate-to-severe diabetes distress (T1-DDS ≥ 2), treated in on of three diabetes outpatient clinics in the Region of Southern Denmark (Odense, Esbjerg, Sønderborg).

Data and biological material

Blood samples (HbA1c levels) Questionnaire data (Demographics, diabetes distress, psychological well-being) Patient Journal (Diabetes technology, diabetes duration, complications, medicin, blood glucose profile - sensor data)

Collaborating researchers and departments

Department of Diabetes and Hormonal Diseases, Esbjerg and Grindsted Hospital

• Senior Physician, Claus Juhl
• Specialist nurse, Heidi Toft Elleman

Department of Medical Diseases, Sønderborg Hospital

• Chief Physician, Frans Brandt Kristensen
• Head nurse, Helle Jacobsen

Steno Diabetes Center Copenhagen

• Professor, Ulla Toft
• Researcher, Bryan Cleal