Premenstrual Dysphoric Disorder Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Alethios Digital Research Platform (Decentralized)
RECRUITING
San Francisco
Contact Information
Primary
Nirav Shah, MD, MPH
nirav@investigator.alethios.com
6267201547
Backup
Zeenia Framroze
support@alethios.com
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Samphire Group, Inc.

This content was sourced from clinicaltrials.gov