Background
Severe mental illness (SMI) presents a major burden to societies worldwide. Low- and middle-income countries (LMICs) often do not have sufficient financial resources and qualified staff to provide extensive specialised services for outpatients with SMI. Our research therefore aims to explore and test low-cost interventions that use existing resources in routine patient-clinician meetings, families and communities.
Methods
In Bosnia-Herzegovina, Colombia and Uganda, three psychosocial interventions will be tested, i.e. making patient-clinician meetings therapeutically effective through DIALOG+, family involvement in multi-family group meetings, and support for patients in befriending schemes with volunteers. All interventions will be provided to patients with SMI, delivered over a six-month period and evaluated with assessments at baseline and after six and 12 months. We will conduct nine trials including non-controlled trials, non-randomised controlled trials and randomised controlled trials (RCTs). Core outcome criteria will be used across all studies. However, details of study delivery and additional outcome criteria vary to accommodate local contexts, interests and priorities. The studies will be analysed separately, but with the option to compare and combine findings.
Discussion
The approach provides the opportunity to learn from commonalities and differences in the results and experiences across the three resource-oriented approaches and the three countries. If successfully implemented the studies can lead to more extensive research and are expected to inform health policies and clinical practice of community care for patients with SMI in the three participating countries and other LMICs.
Trial registration
All RCTs were registered prospectively and non-randomised trials retrospectively within the ISRCTN Registry.
DIALOG+ in Uganda:
ISRCTN25146122
(Date of Registration: 20/11/2018, prospective); DIALOG+ in Colombia:
ISRCTN83333181
(Date of Registration: 20/11/2018, prospective); DIALOG+ in Bosnia-Herzegovina:
ISRCTN13347129
(Date of Registration: 20/11/2018, prospective); Volunteer Support in Uganda:
ISRCTN86689958
(Date of Registration: 04/03/2019, retrospective); Volunteer Support in Colombia:
ISRCTN72241383
(Date of Registration: 04/03/2019, retrospective);Volunteer Support in Bosnia-Herzegovina:
ISRCTN51290984
(Date of Registration: 20/11/2018, prospective); Family Involvement in Uganda:
ISRCTN78948497
(Date of Registration: 04/03/2019, retrospective); Family Involvement in Colombia:
ISRCTN11440755
(Date of Registration: 04/03/2019, retrospective); Family Involvement in Bosnia-Herzegovina:
ISRCTN13347355
(Date of Registration: 20/11/2018, ...
Introduction: The management of long-term physical conditions is a challenge worldwide, absorbing a majority resources despite the importance of acute care. The management of these conditions is done largely in primary care and so interventions to improve primary care could have an enormous impact. However, very little data exist on how to do this. Mental distress is frequently comorbid with long term physical conditions, and can impact on health behaviour and adherence, leading to poorer outcomes. DIALOG+ is a low-cost, patient-centred and solution-focused intervention, which is used in routine patient-clinician meetings and has been shown to improve outcomes in mental health care. The question arises as to whether it could also be used in primary care to improve the quality of life and mental health of patients with long-term physical conditions. This is particularly important for low- and middle-income countries with limited health care resources.
Methods: An exploratory non-controlled multi-site trial was conducted in Bosnia and Herzegovina, Colombia, and Uganda. Feasibility was determined by recruitment, retention, and session completion. Patient outcomes (quality of life, anxiety and depression symptoms, objective social situation) were assessed at baseline and after three approximately monthly DIALOG+ sessions.
Results: A total of 117 patients were enrolled in the study, 25 in Bosnia and Herzegovina, 32 in Colombia, and 60 in Uganda. In each country, more than 75% of anticipated participants were recruited, with retention rates over 90% and completion of the intervention exceeding 92%. Patients had significantly higher quality of life and fewer anxiety and depression symptoms at post-intervention follow-up, with moderate to large effect sizes. There were no significant improvements in objective social situation.
Conclusion: The findings from this exploratory trial suggest that DIALOG+ is feasible in primary care settings for patients with long-term physical conditions and may substantially improve patient outcomes. Future research may test implementation and effectiveness of DIALOG+ in randomized controlled trials in wider primary care settings in low- and middle-income countries.
Trial registration: All studies were registered prospectively within the ISRCTN Registry. ISRCTN17003451, 02/12/2020 (Bosnia and Herzegovina), ISRCTN14018729, 01/12/2020 (Colombia) and ISRCTN50335796, 02/12/2020 (Uganda).
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