{
  "abstract": "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 quality of life (mental component) and affected by under-recruitment.Trial registration number NCT04601311.",
  "authors": [
    {
      "affiliations": [
        "Department of Nephrology and Endocrinology, Center for Cancer and Organ Diseases, University Hospital of Copenhagen - Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark",
        "Odense Universitetshospital Steno Diabetes Center Odense, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Anne Sophie Mathiesen"
    },
    {
      "affiliations": [
        "The Interdisciplinary Research Unit of Women’s, Children’s and Families’ Health, The Julie Marie Center, University Hospital of Copenhagen - Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Public Health, University of Copenhagen, Sector of Health Services Research, Copenhagen, Denmark, UK",
        "School of Nursing and Midwifery and Centre for Quality and Patient Safety Research in the Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia"
      ],
      "name": "Vibeke Zoffmann"
    },
    {
      "affiliations": [
        "Center for Clinical Intervention Research, The Capital Region Copenhagen University Hospital, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Jane Lindschou"
    },
    {
      "affiliations": [
        "Center for Clinical Intervention Research, The Capital Region Copenhagen University Hospital, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Regional Health Research, The Faculty of Heath Sciences, University of Southern Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Janus Christian Jakobsen"
    },
    {
      "affiliations": [
        "Center for Clinical Intervention Research, The Capital Region Copenhagen University Hospital, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Regional Health Research, The Faculty of Heath Sciences, University of Southern Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Christian Gluud"
    },
    {
      "affiliations": [
        "Center for Clinical Intervention Research, The Capital Region Copenhagen University Hospital, Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Neuroanaesthesiology, The Neuroscience Center, University Hospital of Copenhagen - Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Markus Harboe Olsen"
    },
    {
      "affiliations": [
        "Odense Universitetshospital Steno Diabetes Center Odense, Odense, Region Syddanmark, Denmark",
        "Department of Public Health, University of Copenhagen, Sector of Health Services Research, Copenhagen, Denmark, Denmark"
      ],
      "name": "Bodil Rasmussen"
    },
    {
      "affiliations": [
        "The Interdisciplinary Research Unit of Women’s, Children’s and Families’ Health, The Julie Marie Center, University Hospital of Copenhagen - Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Emilie Haarslev Schröeder Marqvorsen"
    },
    {
      "affiliations": [
        "Odense Universitetshospital Steno Diabetes Center Odense, Odense, Region Syddanmark, Denmark",
        "School of Nursing and Midwifery and Centre for Quality and Patient Safety Research in the Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia",
        "Department of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark, Denmark"
      ],
      "name": "Mette Juel Rothmann"
    }
  ],
  "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",
  "uid": "3886455c-b63e-5609-9cc3-670f28a2582c"
}