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CREST: Samphire Guided Care Program for Menstrual and Perimenopausal Symptoms

This study is looking at how well the Samphire Guided Care (SGC) program helps women aged 18-65 who experience mood or thinking problems related to their period, perimenopause (the time leading up to menopause), or menopause. The SGC program is a 12-week digital health program that includes a health professional's assessment, support from a coach, and tracking your symptoms with an app. For some participants, it also involves using a device called Lutea Transcranial Direct Current Stimulation (tDCS), which delivers a gentle electrical current to the head. The study wants to see if this program can improve your work productivity and overall quality of life. The study is currently unclear on its recruitment status.

Study design
This is an observational study with 50 participants, meaning researchers will observe participants without assigning them to specific treatments randomly or blinding them.
What's involved
You would participate in a 12-week structured digital health program, including a clinician-led assessment, ongoing coach support, and daily symptom tracking via an app. If eligible and you choose to, you would also use the Lutea tDCS device at home.
Compensation
Not stated in the trial record.
Follow-up
Your work productivity and quality of life will be measured from the beginning of the study until Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07679074

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

Recruiting
Not specifiedAges 18–65Observational
Samphire Group, Inc.
~50 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Lutea Transcranial Direct Current Stimulation (tDCS) DeviceSamphire Guided Care Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Measured over Baseline to Week 12
+1 more outcome measured

Conditions

Premenstrual Syndrome
Premenstrual Dysphoric Disorder
Dysmenorrhea
Endometriosis
Perimenopause
Menopause
Pelvic Pain

Explore related trials

DysmenorrheaEndometriosisMenopause presentPelvic PainPerimenopausalPremenstrual Dysphoric DisorderPremenstrual syndrome

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Nirav Shah, MD, MPH · PRINCIPAL_INVESTIGATOR · Samphire Group, Inc.

Who to contact

Nirav Shah, MD, MPH
[email protected]
6267201547
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Work Productivity and Activity Impairment (WPAI) - Overall Work ImpairmentBaseline to Week 12

    Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.

  • EQ-5D-5L Utility Index ScoreBaseline to Week 12

    Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.