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

This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program

• 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.

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.

Inclusion Criteria:

• Self-identified female, aged 18-65 years at the time of enrollment
• Basic English literacy
• Able and willing to provide informed consent electronically
• Residing in the United States
• 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)
• Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships
• Currently in full-time employment with medical benefits as part of compensation package
• Access to a smartphone with internet access compatible with the Samphire mobile application
• Able to safely operate the study device in the home environment
• Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program

Exclusion Criteria:

• Pregnancy, breastfeeding, or actively planning pregnancy during the study period
• History of epilepsy or seizure disorder
• Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation
• Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use
• Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use
• Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening
• Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening
• Inability to provide informed consent or safely use the device in the home environment
• Current participation in another interventional neurotechnology or drug study