[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628135":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":23,"armGroups":33,"interventions":44,"overallOfficials":23,"centralContacts":50,"locations":59,"responsibleParty":79,"collaborators":83,"id":86,"slug":23,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":23,"enrollmentInfo":96,"targetDuration":23,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":113,"whyStopped":23,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Universidade do Porto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Perceived stress","Change in perceived stress (PSS-4) total score (range 0-40, higher scores indicating greater perceived stress)","Baseline (pre-intervention) and 4 weeks post-randomization",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Psychological well-being","Change in the WHO well-being index (WHO-5) total score (range 0-40, higher scores indicating greater well-being )",{"measure":18,"description":19,"timeFrame":12},"Coping","Change in coping responses as measured by the Brief COPE Inventory subscale scores (14 subscales, each ranging from 2-8, with higher scores indicating greater use of the respective coping strategy)",{"measure":21,"description":22,"timeFrame":12},"Donor-conception identity","Change in donor conception identity as measured by the Donor Conception Identity Questionnaire (DCIQ) subscale scores, including Concern and Preoccupation (range 8-40), Internalized Stigma (range 5-25), Pride and Acceptance (range 6-30), and Openness and Understanding (range 4-20)\n\nHigher scores indicate greater endorsement of the respective donor conception identity domain.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","This study uses a parallel-group randomized controlled design. Eligible donor-conceived participants are randomly assigned to either the Genesis intervention group or a control group. Participants allocated to the intervention group receive access to a self-guided digital psychoeducational program consisting of five sequential modules that must be completed in a fixed order. Participants in the control group do not receive access to the intervention during the study period. Outcomes are assessed at baseline and post-intervention.\n\nThis is a pilot and feasibility study and is not powered to detect definitive intervention effects.","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":31,"whoMasked":23},"NONE","This is an open-label study. Due to the nature of the self-guided digital psychoeducational intervention, participants are aware of whether they have access to the intervention during the study period. Investigators and study personnel are not masked to allocation. Outcomes are assessed using self-report online questionnaires.","MyGENESIS-PATH was developed as part of the MyGENESIS project using evidence, psychological theory, and input from donor-conceived people. Before the randomized trial, a separate alpha-testing phase will be conducted with a small group of donor-conceived adults and expert reviewers to identify major usability, comprehensibility, acceptability, technical, and safety concerns. Alpha-testing participants will not participate in the randomized trial.\n\nThe registered study is a two-arm randomized pilot and feasibility trial involving 60 donor-conceived adults. After baseline assessment, participants will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control condition.\n\nParticipants allocated to the intervention group will receive access to the self-guided digital intervention for four weeks. The intervention comprises psychoeducational modules, reflective activities, brief check-ins, and tailored coping exercises addressing donor-conception-related information and uncertainty, DNA testing, identity, expectations concerning donors and donor siblings, family relationships, disclosure, stigma, coping, and psychological wellbeing.\n\nParticipants allocated to the waitlist control group will complete the same baseline and four-week assessments and will receive access to the intervention after completing the follow-up assessment.\n\nThe study will primarily assess the feasibility and acceptability of recruitment, randomization, intervention delivery, intervention use, participant retention, and outcome-data collection. Psychological outcomes will be examined descriptively and exploratorily.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"MyGENESIS Intervention","EXPERIMENTAL","Participants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of five sequential self-guided online modules.",[39],"Behavioral: MyGENESIS Digital Psychoeducational Program",{"label":41,"type":42,"description":43,"interventionNames":23},"Waitlist Control Group","NO_INTERVENTION","Participants in this arm do not receive access to the MyGENESIS intervention during the study period and are offered access after completion of post-test assessments.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":23},"BEHAVIORAL","MyGENESIS Digital Psychoeducational Program","A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.",[35],[51,56],{"name":52,"role":53,"phone":54,"phoneExt":23,"email":55},"Mariana V. Martins, PhD","CONTACT","+351 220 400 667","mmartins@fpce.up.pt",{"name":57,"role":53,"phone":54,"phoneExt":23,"email":58},"Maria E. Costa, PhD","ecosta@fpce.up.pt",[60],{"facility":61,"status":23,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Faculty of Psychology and Education Sciences, University of Porto","Porto","Porto District","4200","Portugal","PT",{"type":68,"coordinates":69},"Point",[70,71],-8.61097,41.1485,{"lat":71,"lon":70},[74],{"name":75,"role":53,"phone":76,"phoneExt":77,"email":78},"Research management officer, PhD","226079700","388","tgouveia@fpce.up.pt",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Mariana Veloso Martins","Assistant Professor",[84],{"name":85,"class":6},"Fundação para a Ciência e a Tecnologia","100628135",false,"NCT07457697","MyGENESIS-PATH: A Pilot and Feasibility Trial of a Digital Intervention for Donor-Conceived Adults","A Randomized Pilot and Feasibility Trial of MyGENESIS-PATH, a Digital Psychoeducational Intervention for Donor-Conceived Adults","MyGENESIS-Path","Inclusion Criteria:\n\n* Donor-conceived people\n* Aged 18 or over\n* Able to read and understand English\n* Provide informed consent\n\nExclusion Criteria:\n\n* Not donor-conceived\n* Underaged ot minor\n* Unable to read and understand English\n* Unable to provide informed consent\n* Inability to complete online questionnaires \u002F lack of internet access",true,"ALL","18 Years",{"count":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"NA","MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in managing stress and navigating identity, information, family, DNA-testing, and donor- or sibling-contact-related experiences.\n\nThis randomized pilot and feasibility trial will evaluate the feasibility and acceptability of delivering MyGENESIS-PATH and of conducting a future definitive randomized controlled trial. Sixty donor-conceived adults will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control group. The primary objectives are to assess recruitment, retention, intervention uptake and completion, data completeness, acceptability, usability, and potential unwanted effects. Changes in perceived stress, psychological wellbeing, coping, and donor-conception-related identity will be explored to assess the suitability and variability of outcome measures and to inform the design of a future trial.",[104],"Psychosocial Stress",[106,107,108,109,110,111,15,112],"donor-conceived people","donor conception","Psychoeducational intervention","Digital intervention","Cognitive-behavioral training","Stress and coping","Randomized controlled trial","NOT_YET_RECRUITING","2026-06-18",{"date":116,"type":117},"2026-06-24","ACTUAL",{"date":119,"type":98},"2026-07-01",{"date":121,"type":98},"2026-10-31",{"name":5,"class":6},1]