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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Wearing a device
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well the 12-week Samphire Guided Care program works and how practical it is to use. It combines care team support, an at-home device that uses mild electrical current to stimulate the brain, and an app to track symptoms. It is for women with mood or thinking symptoms linked to periods, the years leading up to menopause, or menopause, and looks at wellbeing, work performance, and quality of life.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Identify as female, be 18–65 years old, and live in the United States.
- Read basic English and be able and willing to give consent online.
- Have at least 3 symptoms linked to periods or menopause: irritability, trouble managing emotions, unclear thinking, tiredness, trouble focusing, sleep problems, or low mood.
- Have symptoms for at least 3 months that disrupt daily life, work, quality of life, or relationships.
- Work full time at a job that includes medical benefits.
- Have a smartphone with internet access that works with the Samphire app.
- Be able to use the study device safely at home.
- Be willing to take part in the 12-week program and answer surveys at the start, middle, and end.
Who can't join
- Be pregnant, breastfeeding, or planning pregnancy during the study.
- Have a history of seizures or a severe or unstable brain or nerve disease that the study team says could make participation unsafe or difficult.
- Have an electronic or metal implant in the head, neck, or brain area that is not safe with the study device.
- Have scalp sores, open wounds, or skin problems where the device pads touch that could make use unsafe.
- Have schizophrenia, bipolar disorder, or another serious mental health condition that screening finds makes participation unsuitable.
- Report current thoughts of suicide, recent suicidal actions, or serious self-harm during screening.
- Be unable to give consent or use the device safely at home.
- Be taking part in another study testing a drug or technology that acts on the brain or nerves.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
CA
- Alethios Digital Research Platform (Decentralized) · San Francisco, CA 94105Zeenia Framroze · Study contact · support@alethios.comNirav Shah, MD, MPH · Principal investigatorMore trials in San Francisco