BackgroundThe Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.MethodsWe propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.ResultsOur application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.ConclusionsIncorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.Trial registrationClinical trials.gov: NCT02160249

Community-based mental health services are emphasized in the World Health Organization’s Mental Health Action Plan, the World Bank’s Disease Control Priorities, and the Action Plan of the World Psychiatric Association. There is increasing evidence for effectiveness of mental health interventions delivered by non-specialists in community platforms in low- and middle-income countries (LMIC). However, the role of community components has yet to be summarized. Our objective was to map community interventions in LMIC, identify competencies for community-based providers, and highlight research gaps. Using a review-of-reviews strategy, we identified 23 reviews for the narrative synthesis. Motivations to employ community components included greater accessibility and acceptability compared to healthcare facilities, greater clinical effectiveness through ongoing contact and use of trusted local providers, family involvement, and economic benefits. Locations included homes, schools, and refugee camps, as well as technology-aided delivery. Activities included awareness raising, psychoeducation, skills training, rehabilitation, and psychological treatments. There was substantial variation in the degree to which community components were integrated with primary care services. Addressing gaps in current practice will require assuring collaboration with service users, utilizing implementation science methods, creating tools to facilitate community services and evaluate competencies of providers, and developing standardized reporting for community-based programs.

BackgroundCommunity-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia.MethodsThis mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members.ResultsThe RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale.ConclusionIn low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.Electronic supplementary materialThe online version of this article (10.1186/s12888-018-1818-4) contains supplementary material, which is available to authorized users.

BackgroundDespite the potential impact on treatment adherence and recovery, there is a dearth of data on the extent and correlates of internalized stigma in patients with schizophrenia in low income countries. We conducted a study to determine the extent, domains and correlates of internalized stigma amongst outpatients with schizophrenia in Ethiopia.MethodsThe study was a cross-sectional facility-based survey conducted at a specialist psychiatric hospital in Addis Ababa, Ethiopia. Consecutive consenting individuals with a diagnosis of schizophrenia were recruited and assessed using an Amharic version of the Internalized Stigma of Mental Illness (ISMI) scale.ResultsData were collected from 212 individuals, who were mostly single (71.2%), unemployed (70.3%) and male (65.1%). Nearly all participants (97.4%) expressed agreement to at least one stigma item contained in the ISMI; 46.7% had a moderate to high mean stigma score. Rural residence (OR = 5.67; 95% CI = 2.30, 13.00; p < 0.001), single marital status (OR = 3.39; 95% CI = 1.40, 8.22; p = 0.019) and having prominent psychotic symptoms (OR = 2.33; 95% CI = 1.17, 4.61; p = 0.016) were associated independently with a higher stigma score. Almost half of those who discontinued their treatment reported that they had done so because of perceived stigma. Those who had attempted suicide (45.3%) were more likely to have a high stigma score (OR = 2.29; 95% CI = 1.27, 4.11; p = 0.006). Over 60% of the variation in the experience of stigma was explained by four factors: social withdrawal (16.7%), perceived discrimination (14.1%), alienation (13.9%) and stereotype endorsement (12.7%).ConclusionInternalized stigma is a major problem among persons with schizophrenia in this outpatient setting in Ethiopia. Internalized stigma has the potential to substantially affect adherence to medication and is likely to affect the recovery process.