RecruitingNot ApplicableNCT06436456

Use of an Online Intervention for the Treatment of Diabetes Distress in Patients With Type 1-Diabetes

The Feasibility, Acceptability and Preliminary Effectiveness of an Internet-based Intervention for Diabetes Distress in Patients With Type 1 Diabetes

Sponsor

Odense University Hospital

Enrollment

40 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1 Diabetes Distress

Summary

This study will investigate whether an online intervention can be helpful in reducing diabetes distress in people with type 1 diabetes and elevated diabetes distress, compared to individual counselling sessions (online, phone-based or face-to-face, depending on the preference of the person with type 1 diabetes). Half of the participants will receive the online intervention, while the other half will receive individual counseling sessions with a psychologist. Objectives: The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress, in comparison with individual counselling sessions. Hypotheses: The investigators predict that both interventions will be feasible to use, shown by how many people join, stay engaged, and complete the interventions. The investigators also think that people will find both interventions acceptable, as shown by the positive feedback given in interviews after they finish.

Eligibility

Min Age: 30 Years

Inclusion Criteria5

A total score or a score on one of the subscales of the Diabetes Distress Scale for type 1 diabetes which is 2 or above.
Diagnosed with type 1-diabetes ≥ 12 months ago.
Age ≥ 30 years.
Receiving treatment at SDCO.
Proficiency in Danish and basic IT skills.

Exclusion Criteria3

Psychiatric diagnosis that may compromise participation in the intervention e.g. psychosis, schizophrenia, substance or alcohol abuse.
Cognitive impairments that may compromise participation in the intervention e.g. dementia, Alzheimer's, brain injury.
Complex issues best suited for individual treatment as assessed by the clinical psychologist.

Interventions

BEHAVIORALOnline psychological intervention

The online intervention constitutes a psychological intervention rooted in therapeutic principals of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Comprising 7 obligatory modules and 4 optional modules, the intervention is facilitated through an online platform, offering a text-based self-help program. Patients receive written guidance from a psychologist at Steno Diabetes Center Odense (SDCO). While undergoing intervention, patients have the option to seek clarification or assistance from the psychologist if encountered with queries or difficulties. It is anticipated that patients will progress through approximately one module per week. Following completion of the intervention, patients retain access to the online intervention for a duration of 3 months.

BEHAVIORALIndividual psychological intervention

In the individual intervention, patients undergo personalized therapy administered by the assigned psychologist from SDCO. This treatment approach is grounded in the principles of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Delivery of treatment can occur through various modalities, including telephone, video conferencing, or in-person sessions, tailored to accommodate the preferences and requirements of the patient. A maximum of 10 treatment sessions are available for each patient.