Abstract
BackgroundSevere 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.MethodsIn 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.DiscussionThe 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 registrationAll 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, prospective).
Highlights
Severe mental illness (SMI) presents a major burden to societies worldwide
One approach is that research should aim to test and implement evidence-based interventions in Low- and middle-income countries (LMICs), most of which have exclusively been studied in High-income countries (HICs) [2]
Such an approach has limitations: a) using current evidence-based interventions in a different context might be inappropriate and ineffective, as most interventions in mental health care have only small to medium effect sizes; b) many interventions, such as the majority of formal psychological treatments, require significant funding and qualified professional staff, none of which is usually available in LMICs; and c) in various LMICs there are likely to be resources in individuals, families and communities, that may not exist to the same extent in HICs but can be utilised to help people alleviate or overcome the distress of mental disorders
Summary
Interventions and study designs The research conducted by the Group will test three aforementioned interventions - making patient-clinician meetings therapeutically effective through DIALOG+, family involvement in multi-family group meetings, and support for patients in befriending schemes with volunteers. DIALOG+ will be tested in three cluster randomised controlled trials, in which mental health professionals and their patients, i.e. clusters, are randomly allocated either to the experimental or the control group. Patients in the control group will receive an intervention on a tablet, where they will be asked to complete the DIALOG scale which includes only satisfaction ratings, with minimal input from clinicians This will be done at the end of their routine sessions so that the ratings will not influence the communication during the meeting. The BPRS guide has been translated into the local languages, and all researchers will be trained in BPRS assessments and interrater-reliability will be established prior to baseline data collection
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