scholarly journals Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic multicentre randomised controlled trial (UPSIDES-RCT)

2020 ◽  
Author(s):  
Galia Sharon Moran ◽  
Jasmine Kalha ◽  
Annabel Mueller-Stierlin ◽  
Reinhold Kilian ◽  
Silvia Krumm ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Cost Effectiveness ◽  
Peer Support ◽  
Low Income ◽  
Social Inclusion ◽  
Controlled Trial ◽  
Low Income Countries ◽  
Service Users ◽  
Randomised Controlled

Abstract Background: Peer support is an established intervention involving a person recovering from mental illness to support others with mental illness.. Peers are an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at multiple levels, including: service user outcomes (psychosocial and clinical); peer support worker outcomes (work role, empowerment); service outcomes (cost-effectiveness, return on investment); and implementation outcomes (adoption, sustainability, organisational change). Methods: UPSIDES-RCT is a pragmatic parallel-group multi-centre randomised controlled trial assessing the effectiveness of UPSIDES at four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), with embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, United Kingdom, Israel, India, Uganda, Tanzania). The primary outcome is social inclusion of service users with severe mental illness (N= 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (Empowerment Scale), hope (HOPE scale), recovery (Stages of Recovery), and health and social functioning (Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect, and implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers, policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. Discussion: The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention in different cultural, organisational and resource settings. By actively involving and empowering service users, UPSIDES will move mental health systems toward a recovery orientation, emphasising user-centeredness, community participation, and the realisation of mental health as a human right.

scholarly journals Peer support for people with severe mental illness versus usual care: study protocol for a pragmatic multicentre randomised controlled trial (UPSIDES-RCT)

2020 ◽  
Author(s):  
Galia Sharon Moran ◽  
Jasmine Kalha ◽  
Annabel Mueller-Stierlin ◽  
Reinhold Kilian ◽  
Silvia Krumm ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Cost Effectiveness ◽  
Severe Mental Illness ◽  
Peer Support ◽  
Social Inclusion ◽  
Controlled Trial ◽  
Service Users ◽  
Randomised Controlled

Abstract Background: Peer support is an established intervention involving a person in recovery from mental illness being engaged to offering support to others with mental illness. Peers are an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at the levels of service users (psychosocial and clinical outcomes), peer support workers (work role, empowerment), services (cost-effectiveness, return on investment), and implementation (adoption, sustainability, organisational change). Methods: UPSIDES-RCT is a pragmatic parallel-group multi-centre randomised controlled trial assessing the effectiveness of UPSIDES at four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), and embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, United Kingdom, Israel, Uganda, Tanzania, India). The primary outcome is social inclusion of service users with severe mental illness (N= 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (Empowerment Scale), hope (HOPE scale), recovery (Stages of Recovery), and health and social functioning (Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect, and implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers, and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. Discussion: By implementing and evaluating a manualized peer support intervention for people with severe mental illness across low-, middle-, and high-income countries, this study will contribute to harmonising core elements of peer support across different cultural and organisational dimensions. The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention. Performance of mental health services will be maximised by actively involving and empowering service users, generating system changes towards user-centeredness, recovery orientation, community participation, and realising mental health as a human right. Trail registration: ISRCTN, ISRCTN26008944. Registered 30 October 2019, http://www.isrctn.com/ISRCTN26008944.

scholarly journals Study protocol for a randomised controlled trial evaluating the effectiveness of strengths model case management (SMCM) with Chinese mental health service users in Hong Kong

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026399 ◽  
Author(s):  
Samson Tse ◽  
Sau Man Catalina Ng ◽  
Wing Yan Winnie Yuen ◽  
Sadaaki Fukui ◽  
Richard J Goscha ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Service Users ◽  
Model Case ◽  
Randomised Controlled ◽  
The University

IntroductionStrengths-based approaches mobilise individual and environmental resources that can facilitate the recovery of people with mental illness. Strengths model case management (SMCM), developed by Rapp and Goscha through collaborative efforts at the University of Kansas, offers a structured and innovative intervention. As evidence of the effectiveness of strengths-based interventions come from Western studies, which lacked rigorous research design or failed to assure fidelity to the model, we aim to fill these gaps and conduct a randomised controlled trial (RCT) to test the effectiveness of SMCM for individuals with mental illness in Hong Kong.Methods and analysisThis will be an RCT of SMCM. Assuming a medium intervention effect (Cohen’s d=0.60) with 30% missing data (including dropouts), 210 service users aged 18 years or above will be recruited from three community mental health centres. They will be randomly assigned to SMCM groups (intervention) or SMILE groups (control) in a 1:1 ratio. The SMCM groups will receive strengths model interventions from case workers, whereas the SMILE groups will receive generic care from case workers with an attention placebo. The case workers will all be embedded in the community centres and will be required to provide a session with service users in both groups at least once every fortnight. There will be two groups of case workers for the intervention and control groups, respectively. The effectiveness of the SMCM will be compared between the two groups of service users with outcomes at baseline, 6 and 12 months after recruitment. Functional outcomes will also be reported by case workers. Data on working alliances and goal attainment will be collected from individual case workers. Qualitative evaluation will be conducted to identify the therapeutic ingredients and conditions leading to positive outcomes. Trained outcome assessors will be blind to the group allocation.Ethics and disseminationEthical approval from the Human Research Ethics Committee at the University of Hong Kong has been obtained (HRECNCF: EA1703078). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration number12617001435370; Pre-results.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Mean Corpuscular Volume as a Marker for Adherence to Zidovudine-Containing Therapy in HIV-Infected Adults

2012 ◽  
Vol 6 (1) ◽  
pp. 45-52 ◽  
Author(s):  
Joseph O Mugisha ◽  
Katherine Donegan ◽  
Sarah Fidler ◽  
Gita Ramjee ◽  
Andrew Hodson ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Low Income ◽  
Mean Corpuscular Volume ◽  
Controlled Trial ◽  
Low Income Countries ◽  
Corpuscular Volume ◽  
Hiv Rna ◽  
Cart Initiation ◽  
Short Course ◽  
Randomised Controlled

Objectives: To assess whether mean corpuscular volume (MCV) is useful in detecting non-adherence to AZTcontaining therapy. Design: Observational study within randomised controlled trial. Methods: We combined data from two treatment arms in SPARTAC, an RCT of short-course cART in primary HIV infection, classifying participants as responders (HIV-RNA decrease ≥1 log10 or reaching <400copies/ml) or nonresponders following cART initiation. We assessed the sensitivity and specificity of using different percentage increases in MCV for accurately differentiating between responders and non-responders. We further examined changes in MCV levels up to 24 weeks after protocol-indicated cART cessation. Results: Of 119 participants included in this analysis, 73 (61%) were women, 71 of whom were randomised in Africa. Ninety-eight (88%) and 84 (85%) were classified as responders at 4 and 12 weeks respectively following cART initiation. MCV increased by a mean 3% and 1% at week 4, and 14% and <1% at 12 weeks for responders and non-responders. A 2% MCV increase at 4 weeks had 62% sensitivity and specificity for identifying virological response. At 12 weeks, an 8% increase had 89% sensitivity and specificity. In responders, MCV remained lower for individuals in African compared to non-African sites throughout and rose from 85 vs 90 fL at cART start to 96 vs 103 fL at 12 weeks post-initiation then fell to 88 vs 93 fL and 86 vs 89 fL at 12 and 48 weeks post-cessation. Conclusion: In low-income countries, where HIV RNA may be unavailable, 12-weekly MCV measurements may be useful in monitoring adherence to AZT-containing regimens.

scholarly journals School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Implementation Evaluation ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

scholarly journals Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Secondary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Implementation Evaluation ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken. Methods and analysis Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3–6 months later, and 9–12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact. Discussion This trial aims to address important questions about whether schools’ practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial. Trial registration ISRCTN16386254. Registered on 30 August 2018.

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