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Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+).

ABSTRACT: Background:The prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6-8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial. Methods:This protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n?=?60) or enhanced usual care (EUC; n?=?60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7-10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT. Discussion:Outcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal. Trial registration:ClinicalTrials.gov identifier: NCT03359486.

SUBMITTER: Sangraula M

PROVIDER: S-EPMC6052626 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+).

Sangraula Manaswi M Van't Hof Edith E Luitel Nagendra P NP Turner Elizabeth L EL Marahatta Kedar K Nakao Jolene H JH van Ommeren Mark M Jordans Mark J D MJD Kohrt Brandon A BA

Pilot and feasibility studies 20180718

<h4>Background</h4>The prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy o ...[more]

PMID: 30038793

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Project description:BACKGROUND:Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. METHODS/DESIGN:This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20?±?1?weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. DISCUSSION:This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03747055.

Project description:AIMS:Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal. METHODS:In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC). RESULTS:We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm. CONCLUSION:The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.

Project description:BackgroundPublished by the World Health Organization (WHO) and United Nations High Commissioner for Refugees (UNHCR) in 2015, the mental health Gap Action Programme Humanitarian Intervention Guide (mhGAP-HIG) recommends brief versions of structured psychological interventions for people experiencing symptoms of common mental disorders (CMDs). mhGAP-HIG acknowledges a growing body of evidence suggesting these interventions can be delivered by lay workers to people affected by humanitarian crises in low- and middle-income countries (LMICs). However, there has not yet been a systematic review and synthesis of this evidence. This paper reports the results of a systematic review of qualitative, quantitative, and mixed-methods studies assessing the implementation and/or effectiveness of talk therapies for CMDs when provided by lay workers in LMICs to adults who have survived or are currently living in humanitarian situations.MethodsSeven electronic databases were searched: MEDLINE, Embase, PsycINFO, PsycEXTRA, Global Health, Cochrane Library, and ClinicalTrials.gov . We also hand-searched the contents pages of three academic journals, reference lists of 30 systematic reviews, and online resource directories of two mental health networks. A preliminary list of included studies was circulated to topical experts for review, and all included studies were backward and forward searched. All titles, abstracts, and full-texts were independently double-screened. Quality appraisal and data extraction were carried out by a single reviewer and checked by a second reviewer, using standardised tools. Any disagreements were discussed and referred to a third reviewer as needed.ResultsWe identified 23 unique studies and carried out a narrative synthesis of patient and implementation outcome data. Every evaluation of the effectiveness of lay-delivered talk therapies for adults affected by humanitarian crises in LMICs showed some treatment effect for at least one CMD, and often multiple CMDs. Implementation research generally found these interventions to be acceptable, appropriate and feasible to implement, with good fidelity to manualised therapies.ConclusionAlthough results are promising, particularly for individually-delivered talk therapies based on cognitive behavioural therapy techniques, there is a high degree of heterogeneity in this literature. We make several recommendations on how to improve the quality and generalisability of research on this topic, to facilitate further evidence synthesis.Trial registrationPROSPERO registration number: CRD42017058287 .

Project description:BackgroundYoung people including adolescents face barriers to healthcare and increased risk of poor sexual and reproductive health (SRH), which are exacerbated in humanitarian settings. Our systematic review assessed the evidence on SRH interventions for young people including adolescents in humanitarian settings, strategies to increase their utilisation and their effects on health outcomes.MethodsWe searched peer-reviewed and grey literature published between 1980 and 2018 using search terms for adolescents, young people, humanitarian crises in low- and middle- income countries and SRH in four databases and relevant websites. We analysed literature matching pre-defined inclusion criteria using narrative synthesis methodology, and appraised for study quality.FindingsWe found nine peer-reviewed and five grey literature articles, the majority published post-2012 and mostly high- or medium-quality, focusing on prevention of unintended pregnancies, HIV/STIs, maternal and newborn health, and prevention of sexual and gender-based violence. We found no studies on prevention of mother-to-child transmission (PMTCT), safe abortion, post-abortion care, urogenital fistulae or female genital mutilation (FGM). Thirteen studies reported positive effects on outcomes (majority were positive changes in knowledge and attitudes), seven studies reported no effects in some SRH outcomes measured, and one study reported a decrease in number of new and repeat FP clients. Strategies to increase intervention utilisation by young people include adolescent-friendly spaces, peer workers, school-based activities, and involving young people.DiscussionYoung people, including adolescents, continue to be a neglected group in humanitarian settings. While we found evidence that some SRH interventions for young people are being implemented, there are insufficient details of specific intervention components and outcome measurements to adequately map these interventions. Efforts to address this key population's SRH needs and evaluate effective implementation modalities require urgent attention. Specifically, greater quantity and quality of evidence on programmatic implementation of these interventions are needed, especially for comprehensive abortion care, PMTCT, urogenital fistulae, FGM, and for LGBTQI populations and persons with disabilities. If embedded within a broader SRH programme, implementers and/or researchers should include young people-specific strategies, targeted at both girls/women and boys/men where appropriate, and collect age- and sex-disaggregated data to help ascertain if this population's diverse needs are being addressed.

Dataset Information

Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+).

Publications

Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+).

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