[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622638":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":42,"responsibleParty":54,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychoeducational Intervention","EXPERIMENTAL","Participants in this arm will take part in a 10-week psychoeducational health and lifestyle program designed to support behavioural change related to recovery from Functional Hypothalamic Amenorrhea (FHA). The intervention includes weekly modules focusing on nutrition, exercise behaviours, stress management, and recovery-promoting habits, delivered with evidence-based educational content and practical exercises. Participants will also complete questionnaires and provide blood samples at scheduled timepoints and will be followed for 9 months after the intervention.",[13],"Behavioral: Psychoeducaction or treatment as usual",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Participants in this arm will receive treatment as usual for Functional Hypothalamic Amenorrhea, which may include general clinical advice, routine follow-up, and standard information provided by healthcare services. No structured psychoeducational program will be offered. Participants will complete questionnaires and provide blood samples at the same timepoints as the intervention group.",[19],"Other: Treatment as usual (TAU)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Psychoeducaction or treatment as usual","10 week psychoeducaction or treatment as usual",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Treatment as usual (TAU)","Standard FHA management provided in routine clinical care.",[15],[29],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Hedvig Engberg, MD PhD","CONTACT","+46 08 123 795 02","hedvig.engberg@ki.se",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Anna Strandqvist, PhD","+46 08 123 779 69","anna.strandqvist@ki.se",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"Kvinnohälsan Karolinska Universitetssjukhuset","Stockholm","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],18.06871,59.32938,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hedvig Engberg","Assistant Professor",[59,61],{"name":60,"class":6},"Karolinska University Hospital",{"name":62,"class":63},"FoU Centrum, Landstinget Sörmland","OTHER_GOV","100622638","health-and-lifestyle-support-for-functional-hypothalamic-amenorrhea-100622638",false,"NCT07386223","Health and Lifestyle Support for Functional Hypothalamic Amenorrhea","HEAL-FHA: Health and Lifestyle Support for Functional Hypothalamic Amenorrhea","HEAL-FHA","Inclusion Criteria\n\n* female\n* aged 18-42 years\n* fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)\n* basic proficiency in Swedish\n* access to a computer.\n\nExclusion Criteria:\n\n* Lack of proficiency in language\n* evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).","FEMALE","18 Years","42 Years",{"count":76,"type":77},70,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to learn whether a 10-week psychoeducational health and lifestyle intervention can help women with Functional Hypothalamic Amenorrhea (FHA) restore their endocrine balance and menstrual cycles.\n\nThe main questions the study aims to answer are:\n\nDoes the intervention lead to the return of regular menstrual bleeding? Does it improve hormonal markers associated with FHA recovery? To answer these questions, researchers will compare the 10-week psychoeducational intervention with treatment as usual (TAU). This comparison will help determine whether the structured program leads to faster or more reliable recovery of menstrual and endocrine function than the care women typically receive today.\n\nParticipants will:\n\nTake part in a 10-week psychoeducational program focusing on health behaviors important for FHA recovery (intervention group) or receive treatment as usual (comparison group) Complete questionnaires and health assessments Provide blood samples to measure hormone levels Take part in a gynecological exam to monitor ovary activity and endometrial thickness Be followed for 9 months after the program to track progress This study builds on a previous feasibility study and will help determine whether the intervention is effective and should be used more widely to support women with FHA.",[83],"Hypothalamic Amenorrhea, Functional",[85,86,87,88],"psychoeduction","lifestyle change","menstrual restoration","amenorrhea","NOT_YET_RECRUITING","2026-01-27",{"date":92,"type":93},"2026-02-04","ACTUAL",{"date":95,"type":77},"2026-02-01",{"date":97,"type":77},"2028-12-31",{"name":5,"class":6},1]