Dataset Information

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

ABSTRACT:

Background

Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country.

Methods/design

A randomised, controlled, non-inferiority trial will be carried out in a predominantly rural area of Ethiopia. A sample of 324 people with SMD (diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder or major depressive disorder) with an ongoing need for mental health care will be recruited from 1) participants in a population-based cohort study and 2) people attending a psychiatric nurse-led out-patient clinic. The intervention is a task-sharing model of locally delivered mental health care for people with SMD integrated into PHC delivered over 18 months. Participants in the active control arm will receive the established and effective model of specialist mental health care delivered by psychiatric nurses at an out-patient clinic within a centrally located general hospital. The hypothesis is that people with SMD who receive mental health care integrated into PHC will have a non-inferior clinical outcome, defined as a mean symptom score on the Brief Psychiatric Rating Scale, expanded version, of no more than six points higher, compared to participants who receive the psychiatric nurse-led service, after 12 months. The primary outcome is change in symptom severity. Secondary outcomes are functional status, relapse, service use costs, service satisfaction, drop-out and medication adherence, nutritional status, physical health care, quality of care, medication side effects, stigma, adverse events and cost-effectiveness. Sustainability and cost-effectiveness will be further evaluated at 18 months. Randomisation will be stratified by health centre catchment area using random permuted blocks. The outcome assessors and investigators will be masked to allocation status.

Discussion

Evidence about the effectiveness of task sharing mental health care for people with SMD in a rural, low-income African country will inform the World Health Organisation's mental health Gap Action Programme to scale-up mental health care globally.

Trial registration

NCT02308956 (ClinicalTrials.gov). Date of registration: 3 December 2014.

SUBMITTER: Hanlon C

PROVIDER: S-EPMC4750210 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

Hanlon Charlotte C Alem Atalay A Medhin Girmay G Shibre Teshome T Ejigu Dawit A DA Negussie Hanna H Dewey Michael M Wissow Lawrence L Prince Martin M Susser Ezra E Lund Crick C Fekadu Abebaw A

Trials 20160211

<h4>Background</h4>Task sharing mental health care through integration into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. However, the effectiveness, acceptability, feasibility and sustainability of this service model for people with a severe mental disorder (SMD) have not been evaluated in a low-income country.<h4>Methods/design</h4>A randomised, controlled, non-inferiority trial will be carried out in a predominan ...[more]

PMID: 26865254

Similar Datasets

Project description:BackgroundThere have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia.MethodsIn this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956.FindingsWe recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI -0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of -US$299·82 (95% CI -454·95 to -144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months.InterpretationWHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings.FundingUS National Institute of Mental Health.

Project description:BackgroundIn this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization's guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings.MethodsSpecifically, this study includes a non-randomized pre-pilot (n = 5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n = 40) to assess trial procedures, acceptability, and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation, we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, 1-month follow-up, and 3-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal.DiscussionFindings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings.Trial registrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1 .

Project description:IntroductionSubstance use disorder (SUD) and problematic substance use are global public health concerns with significant multifaceted implications for physical health and psychosocial well-being. The impact of SUD extends beyond the individual to their family while imposing financial and social burdens on the community. Though family-centred interventions have shown promise in addressing SUD, their implementation and impact in low-income and middle-income countries (LMICs) remain underexplored.Methods and analysisPer Joanna Briggs Institute's scoping review protocol, a systematic search strategy was employed across OVID Medline, Embase, PsycINFO, Web of Science-Core Collection, Global Health and CINAHL from 22 February 2024 to 26 February 2024, to identify relevant studies focused on family-centred interventions for SUD in LMIC, devoid of publication time and language constraints. Two independent reviewers will screen the titles, abstracts and full texts, with discrepancies resolved through discussion or third-party reviews. The extracted data charted in a structured form will be visualised by diagrams or tables, focusing on the feasibility and impact of family-centred interventions for SUD in LMIC. For qualitative studies, the findings will be synthesised and presented in thematic clusters, and for studies that report quantitative outcomes, specific health, including SUD and psychosocial, outcomes will be synthesised, aligning with the Population, Concept and Context framework.Ethics and disseminationThese data on substance use, psychosocial outcomes and perspectives of individuals with SUD and their families will be presented in narrative format, highlighting patterns and identifying research gaps. This review aims to synthesise the existing evidence on family-centred interventions for improving substance use and/or psychosocial outcomes in individuals with SUD in LMIC and seeks to inform future policy and practice. Ethics approval is not required for this scoping review, and modifications to the review protocol will be disclosed. Findings will be disseminated through conference proceedings and peer-reviewed publication.

Project description:IntroductionA minority of school-aged children with asthma have persistent poor control and experience frequent asthma attacks despite maximal prescribed maintenance therapy. These children have higher morbidity and risk of death. The first add-on biologic therapy, omalizumab, a monoclonal antibody that blocks immunoglobulin (Ig)E, was licensed for children with severe asthma in 2005. While omalizumab is an effective treatment, non-response is common. A second biologic, mepolizumab which blocks interleukin 5 and targets eosinophilic inflammation, was licensed in 2018, but the licence was granted by extrapolation of adult clinical trial data to children. This non-inferiority (NI) trial will determine whether mepolizumab is as efficacious as omalizumab in reducing asthma attacks in children with severe therapy resistant asthma (STRA) and refractory difficult asthma (DA).Methods and analysisThis is an ongoing multicentre 1:1 randomised NI open-label trial of mepolizumab and omalizumab. Up to 150 children and young people (CYP) aged 6-17 years with severe asthma will be recruited from specialist paediatric severe asthma centres in the UK. Prior to randomisation, children will be monitored for medication adherence for up to 16 weeks to determine STRA and refractory DA diagnoses. Current prescribing recommendations of serum IgE and blood eosinophils will not influence eligibility or enrolment. The primary outcome is the 52-week asthma attack rate. Bayesian analysis using clinician-elicited prior distributions will be used to calculate the posterior probability that mepolizumab is not inferior to omalizumab. Secondary outcomes include Composite Asthma Severity Index, Paediatric Asthma Quality of Life Questionnaire, lung function measures (forced expiratory volume in one second (FEV1), bronchodilator reversibility), fractional exhaled nitric oxide, Asthma Control Test (ACT), health outcomes EuroQol 5 Dimension (EQ-5D) and optimal serum IgE and blood eosinophil levels that may predict a response to therapy. These outcomes will be analysed in a frequentist framework using longitudinal models.Ethics and disseminationThe study has been approved by the South Central-Berkshire Research Ethics Committee REC Number 19/SC/0634 and had Clinical Trials Authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) (EudraCT 2019-004085-17). All parents/legal guardians will give informed consent for their child to participate in the trial, and CYP will give assent to participate. The results will be published in peer-reviewed journals, presented at international conferences and disseminated via our patient and public involvement partners.Trial registration numberISRCTN12109108; EudraCT Number: 2019-004085-17.

Project description:BackgroundSouth Africa (SA) lacks the specialised workforce needed to provide mental health services particularly in the public sector and in rural areas. Mid-level medical workers offer a potential option for mental health task-sharing in countries where they exist, including SA. The objectives of the study were to explore the roles that SA's mid-level medical worker cadre (clinical associates) could play in mental health service delivery, and to explore views on advanced training in mental health for this cadre.MethodsThis was an explorative, qualitative study involving key informants linked to the three clinical associate training programmes in SA. A total of 19 in-depth interviews were conducted with university-based academic staff, facility-based trainers, and student representatives. The interviews were audio-recorded and professionally transcribed. Thematic analysis was conducted with the aid of Atlas.ti software. Themes and subthemes were identified.ResultsThe first theme identified was 'there is a place for them at the table'. Participants felt that there was a definite role for clinical associates in mental health service provision. The levels of care thought most appropriate were primary health care facilities and district hospitals. The most frequently identified role for clinical associates was in providing immediate care and stabilising mental health patients presenting in emergency settings. Other potential settings included inpatient wards, outpatients' departments, and in communities (e.g. home visits). The second theme identified was 'earning a seat at the table'. There was virtually unanimous support for additional training and in particular a postgraduate clinical specialisation in mental health. Participants felt a clinical specialisation in mental health would strengthen the health system by addressing workforce shortages as well as access and equity issues. They also held the view it would strengthen the profession by creating a career path and providing more employment opportunities for clinical associates.ConclusionsThere was broad support for a role for clinical associates in mental health service delivery in SA as well as for the establishing a clinical specialisation in mental health for clinical associates. Clinical associates with advanced training in mental health could potentially play an important role in rural settings to alleviate the shortage of specialist mental health practitioners.

Dataset Information

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

Background

Methods/design

Discussion

Trial registration

Publications

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets