Aims: To examine the effects of a time-limited, problem-orientated psychotherapeutic intervention on self-defined psychological problems and metabolic control in Type 1 diabetic patients with microvascular complications.
Design: Randomized wait-list controlled trial with a follow-up of 6 months.
Setting: Out-patient clinic of a university diabetes centre.
Participants: Forty-six Type 1 diabetic patients with intensified insulin therapy and presence of microvascular diabetic complications. Twenty-four patients were randomly allocated to the intervention group and 22 patients to the control group.
Intervention: Participation in a structured, problem-orientated, time-limited psychotherapeutic intervention (IG). The control group (CG) patients received routine diabetes care in a specialized diabetes university clinic.
Outcome measures: Degree of change of three self-defined main psychological and psychosocial problems (no. 1, no. 2 and no. 3) on a 1-10 graded scale and glycosylated haemoglobin HbA1c values.
Results: Two patients (one in each group) died during the study period. All remaining patients were followed for 6 months. Problem scores were high at baseline in both groups: IG/CG (mean values, standard deviation in parentheses): problem no. 1, 7.8 (2.0)/8.3 (1.7); problem no. 2, 7.7 (2.3)/7.6 (1.8); and problem no. 3, 7.7 (2.3)/7.4 (2.6). At follow-up, all problems were significantly lower in the intervention group (IG) when compared with the CG: IG/CG: problem no. 1, 4.3 (2.9)/6.8 (3.0), P = 0.03; problem no. 2, 3.9 (2.4)/5.8 (2.8), P = 0.03; problem no. 3, 4.7 (2.4)/6.8 (2.4), P = 0.02. Mean HbA1c decreased in the intervention group by 0.6 (1.2)% and increased in the control group by 0.1 (0.7)%, P = 0.016. In patients with suboptimal metabolic control, i.e. HbA1c > 8%, mean HbA1c decreased by 1.0 (1.2)% in the IG and increased by 0.1 (0.7)% in the CG, P = 0.011.
Conclusion: A time-limited, structured, problem-orientated psychotherapeutic intervention decreases the severity of psychological problems and improves metabolic control in Type 1 diabetic patients with microvascular complications and self-management of intensified insulin therapy.