CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life

Recruiting now

Conditions studied: Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis, Perimenopause, Menopause, Pelvic Pain

In brief

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.

Key facts

Study ID

NCT07679074

Run by

Samphire Group, Inc.

People needed

50

Starts

2026-06-01

Expected to finish

2027-03-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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