Type 1 Diabetes and Diabetes Distress

Condition(s) studied

Investigational drug(s) / intervention(s)

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 diabetes distress intervention (REDUCE). Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion. Participants complete an online questionnaire to track diabetes distress after each session. The group process lasts about 3 months. Preliminary results from a feasibility study showed positive outcomes in recruitment, patient satisfaction, and reduction of diabetes distress (publication in progress).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in diabetes distress score using T1-DDS — from baseline to 3 months
  The primary outcome, is a reduction in the degree of diabetes distress measured using the Type 1 Diabetes Distress Scale (T1-DDS). The scale uses a 6 point likert-scale. The combined DDS score is divided by 28 to give a number between 1 and 6. A score between 2,00-2,99 is defined as moderate diabetes distress, and a score above 3,00 is defined as high diabetes distress.

Trial sites (3)

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