[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premenstrual-dysphoric-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premenstrual-dysphoric-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100645235","crest-samphire-guided-care-program-on-wellbeing-work-productivity-and-quality-of-life-100645235",false,"NCT07679074","CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life","A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions","CREST","Inclusion Criteria:\n\n* Self-identified female, aged 18-65 years at the time of enrollment\n* Basic English literacy\n* Able and willing to provide informed consent electronically\n* Residing in the United States\n* Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)\n* Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships\n* Currently in full-time employment with medical benefits as part of compensation package\n* Access to a smartphone with internet access compatible with the Samphire mobile application\n* Able to safely operate the study device in the home environment\n* Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or actively planning pregnancy during the study period\n* History of epilepsy or seizure disorder\n* Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation\n* Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use\n* Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use\n* Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening\n* Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening\n* Inability to provide informed consent or safely use the device in the home environment\n* Current participation in another interventional neurotechnology or drug study",true,"FEMALE","18 Years","65 Years",{"count":22,"type":23},50,"ESTIMATED","OBSERVATIONAL","This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program\n\n* a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.",[27,28,29,30,31,32,33],"Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Dysmenorrhea","Endometriosis","Perimenopause","Menopause","Pelvic Pain",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMDD","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care","RECRUITING","2026-06-25",{"date":53,"type":54},"2026-07-01","ACTUAL",{"date":56,"type":54},"2026-06-01",{"date":58,"type":23},"2027-03-01",{"name":60,"class":61},"Samphire Group, Inc.","INDUSTRY",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":62},"100554211","emotion-regulation-based-internet-delivered-cognitive-behavioural-therapy-for-premenstrual-dysphoric-disorder-100554211","NCT06496139","Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder","Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial","Premensis-s","Inclusion Criteria:\n\n1. PMDD diagnosis according to DSM-5\n2. Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months\n3. Sufficient proficiency in Swedish to comprehend the treatment materials\n4. Access to computer\u002Ftablet\u002Fmobile phone with internet connection\n\nExclusion Criteria:\n\n1. Breastfeeding or pregnancy during the previous three months\n2. Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months\n3. Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results\n4. Ongoing or previous psychological treatment for premenstrual disorders\n5. Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression\n6. Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).","45 Years",{"count":73,"type":23},164,"INTERVENTIONAL",[76],"NA","Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.\n\nPreliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).",[28],[80,81,82],"Internet-delivered cognitive behavioural therapy","Emotion regulation","Premenstrual dysphoric disorder","2025-07-28",{"date":85,"type":54},"2025-07-31",{"date":87,"type":54},"2025-07-14",{"date":89,"type":23},"2028-07",{"name":91,"class":92},"Uppsala University","OTHER",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":74,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100565915","pilot-study-of-the-thriving-with-pmds-program-100565915","NCT06648382","Pilot Study of the 'Thriving With PMDs' Program","Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders","Inclusion Criteria:\n\n* Ages 18-42\n* Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)\n\nExclusion Criteria:\n\n* Taking oral contraceptives\n* Currently in psychotherapy","42 Years",{"count":22,"type":23},[76],"This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.",[105,28],"Premenstrual Disorder",[107,108,82],"Psychotherapy","Premenstrual disorder","2025-04-03",{"date":111,"type":54},"2025-04-06",{"date":113,"type":54},"2024-10-15",{"date":115,"type":23},"2025-10",{"name":117,"class":92},"University of Regina",2]