[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551975":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":78,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD)","EXPERIMENTAL","The intervention integrates Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. Participants will be randomly assigned to the SH+ combined with the PMLD session (n = 105). The participants in the experimental arm will receive SH+ combined with the PMLD session, by non-specialist facilitators.",[13],"Behavioral: SH+ combined with a session for PMLD",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment-As-Usual (TAU)","NO_INTERVENTION","105 participants will be randomly allocated to the Treatment as Usual (TAU) group. Mental health services for asylum seekers in Turkey are provided by the Ministry of Health and different non-governmental organizations. These services include psychosocial support, counseling, mental health screenings, and psychotherapy (AIDA, 2020). As usual, treatment includes usual mental health support and assessment following the standard procedures of the Refugees Association Mental Health Unit.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","SH+ combined with a session for PMLD","The intervention integrates WHO's Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. SH+ is a guided self-help program with five weekly sessions led by facilitators, aimed at managing stress and psychological distress without requiring a diagnosis. This scalable intervention is based on solid research, proven effective in reducing stress and preventing mental health disorders (Tol et al., 2020; Turrini et al., 2019). The PMLD session, based on WHO's Problem Management Plus (PM+), involves focus groups to identify post-migration challenges. Participants share experiences, learn coping strategies, discover local resources, and strengthen social support networks. This integrated approach aims to enhance mental health, address post-migration difficulties, and improve stress reduction skills, supporting adaptation to a new country.",[9],[26],{"name":27,"affiliation":5,"role":28},"Zeynep Keklik","STUDY_DIRECTOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","444 85 44","zeynep.keklik@std.medipol.edu.tr",[35],{"facility":36,"status":18,"city":37,"state":38,"zip":18,"country":39,"countryCode":18,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS)","Istanbul","Sultanbeyli","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],28.94966,41.01384,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":18,"phoneExt":18,"email":18},"Zeynep Keklik, Psychologist",{"type":50,"investigatorFullName":27,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Psychologist, MSc Student","100551975","self-help-plus-and-post-migration-living-difficulties-support-intervention-100551975",false,"NCT06467071","Self Help Plus and Post-Migration Living Difficulties Support Intervention","Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey","Inclusion Criteria:\n\n* Participants must be adults (18 years and above),\n* Selected among Syrian women residing in Turkey under temporary protection,\n* Speak Arabic,\n* Have not received any services from the Refugee Association before,\n* A score of more than 16 on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),\n* A score of more than 15 on the Kessler-10 (K10) Psychological Distress Scale.\n\nExclusion Criteria:\n\n* Have an acute medical condition,\n* At risk of suicide,\n* Have a severe mental disorder,\n* Have severe cognitive impairment",true,"FEMALE","18 Years",{"count":63,"type":64},210,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU) (n = 105). SH+ is a five-session guided self-help intervention focusing on stress management based on Acceptance and Commitment Therapy (ACT). In addition, a session discussing post-migration difficulties and possible problem-management techniques will be integrated after the SH+ intervention. This study aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of an intervention program to address the psychosocial challenges faced by refugee Syrian women. The results will assess the effectiveness of the intervention on psychological distress, focusing on its potential positive effects on psychological distress, stress management, and adaptation processes. Furthermore, the impact of the intervention on the use of association services and psychological flexibility will be examined.",[70,71,72,73],"Psychological Distress","Psychological Trauma","Mental Health","Refugee Health",[75,76,77],"Syrian Women Refugees","Self Help Plus","Post Migration Living Difficulties","NOT_YET_RECRUITING","2024-06-19",{"date":81,"type":82},"2024-06-20","ACTUAL",{"date":81,"type":64},{"date":85,"type":64},"2025-03-30",{"name":5,"class":6},1]