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

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.

Eligibility

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

Conditions8

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