An observational study in Premenstrual Syndrome, Premenstrual Dysphoric Disorder and Dysmenorrhea, sponsored by Samphire Group, Inc.. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Samphire Group, Inc. · Observational
This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.
All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.
Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.
Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.
Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).
Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.
Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.
All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
42 studies on the registry are indexed under Premenstrual Dysphoric Disorder; 10 are open to participants now.
Browse Premenstrual Dysphoric Disorder studies →Samphire Group, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Premenstrual Dysphoric Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Premenstrual Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program. Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking.
Device: Lutea Transcranial Direct Current Stimulation (tDCS) Device · Behavioral: Samphire Guided Care Program
Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program. Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement.
Behavioral: Samphire Guided Care Program
The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home. The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
Also known as: Lutea
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.
Also known as: SGC Program
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.
Time frame: Baseline to Week 12
EQ-5D-5L Utility Index Score
Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.
Time frame: Baseline to Week 12
Patient Health Questionnaire-9 (PHQ-9)
Within-participant change in PHQ-9 total score. Range 0-27; higher scores indicate greater depressive symptom severity. MCID: 5 points.
Time frame: Baseline, Week 6, Week 12
Generalized Anxiety Disorder-7 (GAD-7)
Within-participant change in GAD-7 total score. Range 0-21; higher scores indicate greater anxiety symptom severity. MCID: 4 points.
Time frame: Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Within-participant change in ISI total score. Range 0-28; higher scores indicate greater insomnia severity. MCID: 6 points.
Time frame: Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities). All subscales scored 0-100%; higher scores indicate greater impairment.
Time frame: Baseline, Week 6, Week 12
Premenstrual Symptoms Screening Tool (PSST)
Within-participant change in PSST total score across 19 symptom items and 5 functional impact items. Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden.
Time frame: Baseline to Week 12
BrainHQ Cognitive Assessment
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
Time frame: Baseline to Week 12
Healthcare Resource Utilization (HCRU)
Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items.
Time frame: Baseline to Week 12
Pain Numerical Rating Scale (NRS)
Within-participant change in average pelvic or menstrual pain over the past 7 days. Scored 0-10; higher scores indicate greater pain severity. MCID: 2 points. Exploratory outcome.
Time frame: Baseline, Week 6, Week 12
Patient Global Impression of Change (PGIC)
Participant-rated overall impression of change in hormonal health symptoms since study start. 7-point scale from Very much improved (1) to Very much worse (7). Exploratory.
Time frame: Week 12
Net Promoter Score (NPS)
Participant likelihood to recommend the SGC program. Scored 0-10. Exploratory engagement metric for employer-facing reporting.
Time frame: Week 12, Week 24
Clinical Global Impression of Severity (CGI-S)
Clinician-rated impression of overall symptom severity at onboarding consultation. 7-point scale. Administered by contracted women's health clinician. Exploratory.
Time frame: Baseline
Clinical Global Impression of Improvement (CGI-I)
Clinician-rated impression of overall symptom improvement from baseline to end of program. 7-point scale. Administered by contracted women's health clinician. Exploratory.
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Premenstrual Dysphoric Disorder →
Samphire Group, Inc.