• Dtsch Arztebl Int · Apr 2022

    Randomized Controlled Trial

    An Integrated Psychosomatic Treatment Program for People With Diabetes (psy-PAD)- Results of a Randomized Controlled Trial.

    • Hanna Kampling, Birgit Köhler, Isabell Germerott, Burkhard Haastert, Andrea Icks, Bernd Kulzer, Bettina Nowotny, Norbert Hermanns, and Johannes Kruse.
    • Department of Psychosomatic Medicine and Psychotherapy, Justus Liebig University Gießen; mediStatistica, Wuppertal; Institute for Health Services Research and Health Economics, Center for Health and Society, Faculty of Medicine at Heinrich Heine University Düsseldorf; German Center for Diabetes Research (DZD), München-Neuherberg, Germany; Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ) Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany; Diabetes Center Mergentheim, Germany; Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany University Bamberg; Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf; Clinical Experimentation, Research and Development Pharmaceuticals, Bayer AG, Wuppertal; Department of Psychosomatics and Psychotherapy of the Justus Liebig University Gießen and Philipps University Marburg, Philipps-Universität Marburg.
    • Dtsch Arztebl Int. 2022 Apr 8; 119 (14): 245-252.

    BackgroundMany people with diabetes have permanently elevated blood sugar concentrations and a high level of diabetes-related psychological stress, also called "diabetes distress." In clinical practice, diabetes distress is often an impediment to successful self-management. psy-PAD is a psychodynamically oriented short-term therapy program whose goal is to reduce diabetes distress and improve glycemic control.MethodsA randomized controlled trial was conducted with 143 patients with either type 1 or type 2 diabetes who were being treated in eleven specialized diabetological practices. psy-PAD in the intervention group (eight sessions) was compared with optimized standard care as the control condition. The inclusion criteria were HbA1c ≥ 7.5% combined with diabetes distress (PAID >35, or doctor's determination). The primary endpoint was the HbA1c at six months (t1). Diabetes-related distress (PAID), depressive symptoms (HADS-D, PHQ-9), anxiety symptoms (HADS-A), health-related quality of life (SF-36), panic (short form of the PHQ-D), body mass index (BMI), and triglyceride levels were secondary endpoints. Follow-ups were conducted at six (t1) and 12 months (t2) (trial registration: DRKS00003247).ResultsThe intergroup comparison at t1 revealed a significant, clinically relevant reduction of HbA1c by -0.53 percentage points (95% confidence interval [-0.89; -0.16], p = 0.005). The secondary analyses revealed relevant differences in the point estimators for diabetes distress at t1 and t2, depressive symptoms at t2 and BMI at t1.ConclusionFor people with diabetes and diabetes distress who do not achieve satisfactory glycemic control despite intensive treatment in specialized diabetological practices, integrated psychosomatic-psychotherapeutic treatment can lower blood sugar levels over the intermediate term and also reduce diabetes distress and depressive symptoms over a one-year period.

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