CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
CREST
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
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 25, 2026
CompletedFirst Posted
Study publicly available on registry
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
July 1, 2026
June 1, 2026
7 months
June 25, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (7)
Patient Health Questionnaire-9 (PHQ-9)
Baseline, Week 6, Week 12
Generalized Anxiety Disorder-7 (GAD-7)
Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Baseline, Week 6, Week 12
Premenstrual Symptoms Screening Tool (PSST)
Baseline to Week 12
- +2 more secondary outcomes
Other Outcomes (5)
Pain Numerical Rating Scale (NRS)
Baseline, Week 6, Week 12
Patient Global Impression of Change (PGIC)
Week 12
Net Promoter Score (NPS)
Week 12, Week 24
- +2 more other outcomes
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alethios Digital Research Platform (Decentralized)
San Francisco, California, 94105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nirav Shah, MD, MPH
Samphire Group, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2026
First Posted
July 1, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share