Randomised trials relevant to mental health conducted in low and middle-income countries: a survey

<p>Abstract</p> <p>Background</p> <p>A substantial proportion of the psychiatric burden of disease falls on the world's poorest nations, yet relatively little is known about randomised trials conducted in these countries. Our aim was to identify and describe a representative sample of mental health trials from low and middle-income countries.</p> <p>Methods</p> <p>6107 electronic records, most with full text copies, were available following extensive searches for randomised or potentially randomised trials from low and middle-income countries published in 1991, 1995 and 2000. These records were searched to identify studies relevant to mental health. Data on study characteristics were extracted from the full text copies.</p> <p>Results</p> <p>Trials relevant to mental health were reported in only 3% of the records. 176 records reporting 177 trials were identified: 25 were published in 1991, 45 in 1995, and 106 in 2000. Participants from China were represented in 46% of trials described. 68% of trials had <100 participants. The method of sequence generation was described in less than 20% of reports and adequate concealment of allocation was described in only 12% of reports. Participants were most frequently adults with unipolar depression (36/177) or schizophrenia (36/177). 80% of studies evaluated pharmacological interventions, a third of which were not listed by WHO as essential drugs. 41% of reports were indexed on PubMed; this proportion decreased from 68% in 1991 to 32% in 2000.</p> <p>Conclusion</p> <p>In terms of overall health burden, trial research activity from low and middle-income countries in mental health appears to be low, and in no area adequately reflects need.</p

A cultural experience to support mental health in people aged 16-24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial

Background Despite the high prevalence of common mental disorders in adolescents and young adults, and their association with poor health and socio-economic outcomes throughout the lifespan, many young people do not seek or receive help for such disorders. There is growing interest in the community sector in supporting mental health in young people; however, there is little by way of experimental research in this area. During the COVID-19 pandemic and lockdown, we designed an online cultural experience to reduce anxiety and depression and support mental health in people aged 16–24. Methods/design The O-ACE POP (Online Active Community Engagement Proof of Principle) study is a UK-based online randomised controlled trial of an online cultural experience named Ways of Being, involving human centred narratives and viewpoints, compared with a typical museum website (the Ashmolean Museum). We aim to compare efficacy on affect, symptoms of epression and anxiety, flourishing and loneliness as well as investigating potential mechanisms of action. Discussion The COVID-19 pandemic has provided a unique opportunity to design an innovative approach to supporting mental health in young adults. Findings derived from this study will allow us to evaluate the efficacy of this intervention and will inform the design of studies to further refine the resource and test it further. Trial registration ClinicalTrials.gov NCT04663594. Registered on 11 December 2020 (submitted in same form 27 November 2020). Protocol v1.0: 27 November 2020. Date recruitment began: 4 December 2020. Recruitment complete (estimate): February 202