Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention at t0
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).
wait list control group
Control group for the first 3 months, whereafter the arm will receive the same intervention as arm 1
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
35 Years
ALL
No
Sponsors
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Steno Diabetes Center Odense
OTHER
Odense University Hospital
OTHER
Responsible Party
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Locations
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Esbjerg Hospital
Esbjerg, , Denmark
Odense University Hospital
Odense, , Denmark
Sønderborg Hospital
Sønderborg, , Denmark
Countries
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Facility Contacts
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Other Identifiers
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25/13117
Identifier Type: OTHER
Identifier Source: secondary_id
25/13117
Identifier Type: -
Identifier Source: org_study_id
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