Samphire Guided Care for Wellbeing at Work

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational study conducted entirely at home, comparing two groups of participants who use the Samphire Guided Care (SGC) program. All participants receive onboarding, access to the Lutea tDCS device if eligible, neuromodulation coaching, and app-based symptom tracking. Group A consists of participants who accept and use the device for at least 30% of sessions, while Group B includes those who decline or use it less than 30%; group assignment is determined retrospectively at week 12. Primary outcomes focus on work productivity and employee wellbeing, with several secondary and exploratory measures related to mood, sleep, cognition, and healthcare utilization. The study uses a fully decentralized, at-home format without randomization or blinding.

Why it matters

Who can join: the full rules

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

Where it's running

• Alethios Digital Research Platform (Decentralized)
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Nirav Shah, MD, MPH — Samphire Group, Inc.
• Study coordinator: Nirav Shah, MD, MPH
• Email: nirav@investigator.alethios.com
• Phone: 6267201547

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.