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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Neuromodulation Cohort | 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. |
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| Group B - Comparison Cohort | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutea Transcranial Direct Current Stimulation (tDCS) Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, Week 12 |
| Generalized Anxiety Disorder-7 (GAD-7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, Week 12 |
| Patient Global Impression of Change (PGIC) |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nirav Shah, MD, MPH | Contact | 6267201547 | nirav@investigator.alethios.com | |
| Zeenia Framroze | Contact | support@alethios.com |
| Name | Affiliation | Role |
|---|---|---|
| Nirav Shah, MD, MPH | Samphire Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios Digital Research Platform (Decentralized) | Recruiting | San Francisco | California | 94105 | United States |
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| Samphire Guided Care Program | Behavioral | 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. |
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Within-participant change in GAD-7 total score. Range 0-21; higher scores indicate greater anxiety symptom severity. MCID: 4 points.
| 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. | 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. | 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. | Baseline to Week 12 |
| BrainHQ Cognitive Assessment | Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program. | 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. | Baseline to Week 12 |
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. |
| Week 12 |
| Net Promoter Score (NPS) | Participant likelihood to recommend the SGC program. Scored 0-10. Exploratory engagement metric for employer-facing reporting. | 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. | 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. | Week 12 |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D065446 | Premenstrual Dysphoric Disorder |
| D004412 | Dysmenorrhea |
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005221 | Fatigue |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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