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

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

Plain Language Summary

Simplified for easier understanding

This study tests an online program designed to help people with Type 1 diabetes manage "diabetes distress" — the emotional burden of living with and managing a serious chronic illness every day. **You may be eligible if...** - You have had Type 1 diabetes for at least 12 months - You are 30 years or older - You score 2 or higher on a diabetes-related emotional distress questionnaire - You are currently a patient at SDCO (a Danish diabetes clinic) - You are proficient in Danish and comfortable using basic technology **You may NOT be eligible if...** - You have a psychiatric condition that could interfere with participation (such as psychosis, schizophrenia, or substance abuse) - You have cognitive impairments such as dementia or brain injury - Your psychologist believes your needs are better suited to individual (one-on-one) therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Steno Diabetes Center Odense

Odense, Denmark

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NCT06436456


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