Bipolar Disorder / Mental Disorders · Journal article
Scandinavian Journal of Primary Health Care · August 11, 2026
Encouraging direction, but not yet definitive.
This pilot cluster-RCT evaluated a coordinated GP care program (SOFIA) in 87 adults with severe mental illness across nine Danish practices. The intervention showed no effect on needs-based quality of life or health-related quality of life, but the CCP+ group (care program plus needs-based QoL tool) demonstrated statistically significant improvements in two of five self-perceived inequity domains: not being seen and heard, and powerlessness.
Cluster-randomised controlled pilot trial, non-blinded. Adults with psychotic disorders, bipolar disorder, or severe depressive disorder. Intervention: Coordinated care program (CCP): extended GP consultations, GP and staff training, support connecting patients with health and social services; CCP+ additionally included a needs-based quality-of-life tool. Compared with: Usual care (control). n = 87. Nine general practices in Denmark.
No statistically significant differences between intervention and control groups in changes in needs-based quality of life CCP+ group showed statistically significant improvements in two self-perceived inequity domains: not being seen and heard and powerlessness No significant differences found for remaining inequity domains or health-related quality of life (EQ-5D-5L)
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The selective benefit in inequity perception (being seen and heard, reduced powerlessness) is clinically noteworthy and may reflect the impact of extended consultations and coordinated care on patient experience, even if it does not translate to broader QoL or health gains in this pilot. However, the absence of effect on the primary endpoint and short follow-up mean firm conclusions about clinical utility are premature.
A pilot cluster-RCT with modest sample size and short follow-up showing selective improvements in self-perceived inequity (two domains) but no effect on primary needs-based QoL or health-related QoL; results are real but limited and the authors call for larger trials.
As stated by the source record.
Quoted from the source exactly as published.
The selective benefit in inequity perception (being seen and heard, reduced powerlessness) is clinically noteworthy and may reflect the impact of extended consultations and coordinated care on patient experience, even if it does not translate to broader QoL or health gains in this pilot. However, the absence of effect on the primary endpoint and short follow-up mean firm conclusions about clinical utility are premature.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background. Living with severe mental illness (SMI) adversely affects quality of life (QoL). The SOFIA program, a coordinated general practice care initiative in Denmark, aimed to improve QoL and reduce mortality through extended general practitioner (GP) consultations, training for GPs and staff, and support in connecting patients with relevant health and social services.Objective. To evaluate the impact of the SOFIA intervention on needs-based QoL, self-perceived inequity, and health-related QoL in people with SMI.Design and setting. Cluster-randomised, non-blinded controlled pilot trial conducted in nine Danish general practices between November 2020 and March 2021. Practices were allocated to a coordinated care program (CCP; n = 27), CCP plus a needs-based QoL tool (CCP+; n = 37), or usual care (control; n = 23).Subjects. Adults with psychotic disorders, bipolar disorder, or severe depressive disorder.Main outcome measures. Outcomes were assessed using the Multi-Morbidity Questionnaire (MMQ) and the EQ-5D-5L.Results. No statistically significant differences were observed between intervention and control groups in changes in needs-based QoL. Compared with the control group, the CCP+ group showed statistically significant improvements in two self-perceived inequity domains: not being seen and heard and powerlessness. No significant differences were found for the remaining inequity domains or health-related QoL.Conclusion. The findings suggest that comprehensive, coordinated GP consultations may help reduce feelings of inequity among people with SMI. Larger pragmatic randomised controlled trials with adequate power and longer follow-up are needed to determine the intervention's effectiveness on patient-reported outcomes and long-term health.Trial registration The pilot trial protocol registration was dated 05/11/2020, and the registration number is NCT04618250.
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