Academic Journal
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
| Title: | 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 |
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| Authors: | Mathiesen, Anne Sophie, Zoffmann, Vibeke, Lindschou, Jane, Jakobsen, Janus Christian, Gluud, Christian, Olsen, Markus Harboe, Rasmussen, Bodil, Marqvorsen, Emilie Haarslev Schröeder, Rothmann, Mette Juel |
| Source: | Mathiesen, A S, Zoffmann, V, Lindschou, J, Jakobsen, J C, Gluud, C, Olsen, M H, Rasmussen, B, Marqvorsen, E H S & Rothmann, M J 2026, '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', BMJ Open, vol. 16, no. 6, e111164. https://doi.org/10.1136/bmjopen-2025-111164 |
| Publication Year: | 2026 |
| Collection: | University of Copenhagen: Research / Forskning ved Københavns Universitet |
| Subject Terms: | Humans, Diabetes Mellitus, Type 2/psychology, Female, Middle Aged, Male, Quality of Life, Depression/prevention & control, Aged, Personal Autonomy, Adult, Ambulatory Care Facilities, Surveys and Questionnaires, Anxiety, Stress, Psychological/prevention & control, Single-Blind Method, Self Care/methods |
| Description: | 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). Linear regression showed beneficial effects of GSD on diabetes distress (mean difference (MD) −5.83; 98.75% CI −11.26 to −0.41) and depression (MD −2.77; 98.75% CI −5.24 to −0.30) but below our predefined minimal important differences. Quality of life (mental component) improved (MD 8.10; 98.75% CI 0.94 to 15.27), exceeding our predefined minimal important difference. We found no differences on the physical component of quality of life (MD 1.79; 98.75% CI −5.72 to 9.31), adverse events (MD 0.00; 98.75% Hodges-Lehmann CI 0.00 to 0.00) or the tertiary outcomes: HbA1c or motivation. Conclusions The GSD intervention versus attention control reduced diabetes distress and depression and improved quality of life (mental component). The effect sizes were below the predefined minimal important difference, except for ... |
| Document Type: | article in journal/newspaper |
| File Description: | application/pdf |
| Language: | English |
| ISSN: | 2044-6055 |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/42350025; info:eu-repo/semantics/altIdentifier/pissn/2044-6055; info:eu-repo/semantics/altIdentifier/eissn/2044-6055 |
| DOI: | 10.1136/bmjopen-2025-111164 |
| Availability: | https://researchprofiles.ku.dk/da/publications/c953b8f7-930e-4e58-9836-705d8eaf9919 https://doi.org/10.1136/bmjopen-2025-111164 https://curis.ku.dk/ws/files/557491554/e111164.full.pdf |
| Rights: | info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: | edsbas.C7B118E9 |
| Database: | BASE |
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