A Guided Self-Determination Intervention vs. an Attention Control Group of People with Type 2 Diabetes in an Outpatient Clinic Setting-A Randomised Clinical Trial

Introduction and Objective: Evidence suggests that the autonomy supportive intervention, the guided self-determination method (GSD), may reduce diabetes distress in people with type 1 diabetes. The objective was to determine the benefits and harms of a GSD intervention versus an attention control group in adults with type 2 diabetes. Methods: The design was a pragmatic, dual-centre, randomised, assessor-blinded, superiority clinical trial of adults (≥18 years) with type 2 diabetes. The participants were randomly assigned to GSD versus attention control group, both groups provided face-to-face or over video. The primary outcome was diabetes distress assessed with the Problem Areas in Diabetes questionnaire. The secondary outcomes were depressive symptoms assessed with Hospital Anxiety and Depression scale; quality of life assessed with SF-36; and non-serious adverse events assessed with the Negative Effects Questionnaire at baseline and 5- and 12-months follow-up. Results: The trial included 150 participants (GSD n=76 versus attention control n=74). This was below our predefined sample size and thresholds for statistical significance were adjusted accordingly. Linear regression showed evidence of beneficial effects of GSD on diabetes distress (MD -5.83; 98.75% CI -11.26;-0.41, p=0.007) and depression (MD -2.77; 98.75% CI -5.24;-0.30, p=0.005). Linear regression showed evidence of a beneficial effect of attention control on quality of life (mental component) (MD 8.10; 98.75% CI 0.94;15.27, p=0.005) but no difference on the physical component (MD 1.79; 98.75% CI -5.72;9.31) or adverse events (MD 0.00; 98.75% Hodges-Lehmann CI 0.00;0.00). Conclusion: The GSD intervention versus attention control seems to reduce diabetes distress and depression. Attention control may improve quality of life. Disclosure A.S. Mathiesen: None. V. Zoffmann: None. M. Olsen: None. J.C. Jakobsen: None. E.H.S. Marqvorsen: None. J. Lindschou: None. B. Rasmussen: None. C. Gluud: None. M.D. Rothmann: None. Funding The Novo Nordisk Foundation, Steno Collaborative Grant (NNF10OC0057720)