Abstract
BACKGROUND: Many 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. METHODS: A 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). RESULTS: The 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. CONCLUSION: For 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.