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Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.
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There is increasing evidence supporting the effectiveness of scalable mental health and psychosocial support (MHPSS) interventions delivered by non-specialists for improving wellbeing among migrant populations in humanitarian settings. Balancing fidelity in the implementation of evidence-based MHPSS interventions with their fit to the needs and preferences of new populations and contexts remains a challenge when introducing MHPSS interventions in new settings. This paper describes a community-based participatory approach to MHPSS intervention design incorporating processes to promote local adaptability and fit while maintaining standardized elements of existing MHPSS interventions. We conducted a mixed-methods study to design a community-based MHPSS intervention that fit the mental health and psychosocial needs of migrant women in three sites in Ecuador and Panama. Drawing from a set of community-based participatory research methods, we identified the priority mental health and psychosocial needs among migrant women, co-developed intervention mechanisms that aligned with those needs, matched mechanisms to existing psychosocial intervention components, and iteratively piloted and refined the intervention with community stakeholders. The resulting intervention was a five-session, lay facilitator-delivered group intervention titled, Entre Nosotras ('among/between us'). The intervention combined elements of individual and community problem solving, psychoeducation, stress management, and social support mobilization to address prioritized problems including psychological distress, safety, community connectedness, xenophobia and discrimination, and social support. This research outlines an emphasis on the social dimension of psychosocial support, as well as a process for balancing fit and fidelity in intervention design and implementation.
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BACKGROUND: Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras. METHODS: This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period. DISCUSSION: Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05130944 . Registered November 23, 2021-retrospectively registered.
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This study evaluates the antimicrobial and antifungal potential of the essential oil extracted from a species located in the Andes of Ecuador, Piper barbatum Kunth, known as "cordoncillo" or "allupa", used by the Quichua people as an antibacterial plant for washing female genitalia in cases of infection. The most abundant molecules in the essential oil were: α- phellandrene (43.16%), limonene (7.04%); some oxygenated sesquiterpenes such as: trans-sesquisabinene hydrate (8.23%), elemol (7.21%) and others. The evaluation of antimicrobial activity showed activity in all the strains analyzed; however, those in which MIC values are considered to be very strong (less than 500 µg/mL) are: Staphylococcus aureus 264 µg/mL, Streptococcus mutans 132 µg/mL, Candida albicans 132 µg/mL and Candida tropicalis 264 µg/mL. Antimicrobial bioautography defines which molecules are responsible for the activity; thus, it was possible to establish the chromatographic regions of = 0.02 and Rf = 0.04, as those with active molecules. It was established that 4 hydroxylated sesquiterpene molecules are involved: elemol (7.21%), trans-sesquisabinene hydrate (8.23%), ß-eudesmol (3.49%) and 10-epi-γ-eudesmol (1.07%); the last two being the most active. The aim of this manuscript is to analyze both the ancestral knowledge of the Quichua people of Ecuador, and the chemical-biodiversity of the Andean forest ecosystem, in order to provide new raw materials of pharmaceutical interest.