Capturing diabetes-related stress from the perspective of patients with type 1 and type 2 diabetes: an exploratory study using a mixed-methods desig

Recruiting

Conditions: E10
E11
Type 1 diabetes mellitus
Type 2 diabetes mellitus

Registration Number: DRKS00024999

Lead Sponsor: niversitätsklinikum Gießen und Marburg, Klinik für Psychosomatik und Psychotherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Included are patients who have been medically diagnosed with type 1 diabetes or type 2 diabetes for at least 1 - 2 years, whose HbA1c value is above 7.5%, who have participated in at least one diabetes training course and who have sufficient German language skills and cognitive abilities.

Exclusion Criteria

Patients will be excluded if they have been diagnosed with type 3 diabetes or gestational diabetes, have a severe comorbid condition (e.g., current oncologic disease that modifies the indication for metabolic control), have limitations that, in the opinion of the medical staff at the clinic, significantly limit their ability to participate in the study (e.g., dementia, major depressive episode, psychosis, or addiction), have a physician-diagnosed diabetic foot syndrome, or are bedridden or require nursing care. e.g., dementia, major depressive episode, psychosis, or addiction), who have a medically diagnosed diabetic foot syndrome, and who are bedridden or in need of nursing care.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Based on qualitative data collection and evaluation, two overviews are to be developed as the main outcome parameters, which, from the patient's perspective, are indication specific for type 1 and type 2 diabetes, the individual diabetes-related burdens, critical times in the course of treatment (with a special focus on the times of the diagnosis notification, possible medication changes and drastic events in the social area) as well as barriers and support factors.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters include quantitative data collection on the following three domains: <br>1.Diabetes-related emotional stress in the context of diabetes disease and treatment requirements (recorded with questionnaire: PAID), <br>2.Psychological complaints, especially depressive symptomatology and anxiety symptomatology (recorded with questionnaire: PHQ-D), <br>3. experiences of abuse and neglect in childhood (recorded with questionnaire: CTQ-SF)<br>4. epistemic trust (recorded with questionnaire: ETMCQ)<br>5. impairment of basal mentalizing skills (recorded with questionnaire: MZQ),<br>6. Structural limitations of personality (recorded with questionnaire OPD-SFK)<br>7. medical parameters: Diabetes type; HbA1c; medication; weight and height; blood levels of total cholesterol, LDL and HDL cholesterol, and triglycerides; information on existing pre-existing conditions.