Guided self-determination intervention versus an attention control group of people with type 2 diabetes in an outpatient clinic setting--the OVERCOME randomised clinical trial

Objective Autonomy supportive interventions such as the guided self-determination method (GSD), may reduce diabetes distress in people with type 2 diabetes. The objective was to investigate the benefits and harms of GSD intervention versus attention control group intervention in adults (≥18 years old) with type 2 diabetes.

Research designs and methods The design was a pragmatic, dual-centre, randomised, assessor-blinded, superiority clinical trial. People with type 2 diabetes were assigned by computer-generated randomisation to GSD or attention control, both interventions provided face-to-face, over telephone, or via video.

The primary outcome was diabetes distress assessed with the Problem Areas in Diabetes questionnaire at 12 month follow-up. The secondary outcomes were depressive symptoms assessed with the Hospital Anxiety and Depression scale; quality of life assessed with the 36-Item Short Form Health Survey (SF-36); and non-serious adverse events assessed with the Negative Effects Questionnaire at 12 month follow-up.

Statisticians were blinded to group allocation. Results The trial was stopped early after a total of 150 of 224 planned participants were randomised (GSD n=74; attention control n=76).