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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Feb 28, 2025
Date Accepted: Sep 18, 2025

The final, peer-reviewed published version of this preprint can be found here:

Access to a Newly Adapted Diabetes-Specific Multimodal Cross-Sectoral and Interdisciplinary Psychotherapeutic Care Option for a High-Risk Group of Patients With Diabetes Mellitus and Distress: Protocol for the minDBe Pilot Study

Zara S, Kruse J, Kampling H

Access to a Newly Adapted Diabetes-Specific Multimodal Cross-Sectoral and Interdisciplinary Psychotherapeutic Care Option for a High-Risk Group of Patients With Diabetes Mellitus and Distress: Protocol for the minDBe Pilot Study

JMIR Res Protoc 2025;14:e73199

DOI: 10.2196/73199

PMID: 41105937

PMCID: 12579286

Study protocol for the minDBe pilot study: access to a newly adapted diabetes specific multimodal cross-sectoral and interdisciplinary psychotherapeutic care offer for a high-risk group of patients with diabetes mellitus and distress

  • Sandra Zara; 
  • Johannes Kruse; 
  • Hanna Kampling

ABSTRACT

Background:

Background:

Diabetes is a chronic disease requiring daily self-management to regulate e.g., glycemic control. Despite extensive trainings being available, the majority of patients with diabetes do not meet their target blood sugar levels. Moreover, diabetes-related emotional distress and psychological burden in the form of depressive and anxiety symptoms are highly common. Patients with these challenges represent a high-risk group in terms of increased morbidity, mortality, and health care costs as well as decreased quality of life. Hence, in addition to somatically focused standard care, this patient group requires specific treatment offers also addressing psychosocial aspects. However, these treatment offers are often not available in routine care. Psychosomatic Outpatient Clinics (PsIA) could address this gap by offering multimodal and integrative treatment. Yet, the indication for treatment in the PsIA as well as the referral pathways of patients with diabetes from practices or diabetes clinics to the PsIAs remain complicated. Moreover, specific treatment offers have to be adapted.

Objective:

To assess the needs for referral pathways to the PsIA from the patient and service provider perspective, and to adapt the already effective psychosomatic intervention psy-PAD for a group setting (psy-PADGroup) fitting the multimodal PsIA structures.

Methods:

This pilot study comprises an explorative qualitative design based on a multi-level approach, employing two work packages: work package I) assesses the patient perspective (n=40) employing focus groups as well as the service provider perspective with interviews (n=30). Work package II) comprises an expert-workshop with clinicians and patient representatives (n=10) to adapt the psy-PADGroup manual for the modalities of the PsIA. The patient focus groups and service provider interviews will be audio recorded. The audio recordings will be transcribed and analyzed employing content analysis within the framework of interpretative text evaluations with the software MAXQDA.

Results:

Outcomes will be 1) the needs regarding referral pathways, 2) short questionnaires to economically assess the acceptance and feasibility of the referral pathways in preparation for the minDBe main study, and 3) the adapted psy-PADGroup intervention for an interdisciplinary multimodal treatment offer to be implemented in the structures of the PsIA.

Conclusions:

The minDBe pilot study will lay the foundation for the minDBe main study, which aims to evaluate psy-PADGroup as part of an interdisciplinary multimodal psychotherapeutic treatment program by employing a randomized controlled trial. Clinical Trial: Trial Registration: DRKS00031873.


 Citation

Please cite as:

Zara S, Kruse J, Kampling H

Access to a Newly Adapted Diabetes-Specific Multimodal Cross-Sectoral and Interdisciplinary Psychotherapeutic Care Option for a High-Risk Group of Patients With Diabetes Mellitus and Distress: Protocol for the minDBe Pilot Study

JMIR Res Protoc 2025;14:e73199

DOI: 10.2196/73199

PMID: 41105937

PMCID: 12579286

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