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

25 de junio de 2026 actualizado por: Samphire Group, Inc.

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.

All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.

Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.

Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.

Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).

Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.

Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.

All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.

Tipo de estudio

De observación

Inscripción (Estimado)

50

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94105
        • Reclutamiento
        • Alethios Digital Research Platform (Decentralized)
        • Investigador principal:
          • Nirav Shah, MD, MPH
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Dispositivo: Lutea Transcranial Direct Current Stimulation (tDCS) Device
The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home. The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
Otros nombres:
  • Lutea
Conductual: Samphire Guided Care Program
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.
Otros nombres:
  • SGC Program
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.
Conductual: Samphire Guided Care Program
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform. All participants in both groups receive this program component.
Otros nombres:
  • SGC Program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Periodo de tiempo: Baseline 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.
Baseline to Week 12
EQ-5D-5L Utility Index Score
Periodo de tiempo: Baseline 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.
Baseline to Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline, Week 6, Week 12
Within-participant change in PHQ-9 total score. Range 0-27; higher scores indicate greater depressive symptom severity. MCID: 5 points.
Baseline, Week 6, Week 12
Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline, Week 6, Week 12
Within-participant change in GAD-7 total score. Range 0-21; higher scores indicate greater anxiety symptom severity. MCID: 4 points.
Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Periodo de tiempo: Baseline, Week 6, Week 12
Within-participant change in ISI total score. Range 0-28; higher scores indicate greater insomnia severity. MCID: 6 points.
Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Periodo de tiempo: Baseline, Week 6, Week 12
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities). All subscales scored 0-100%; higher scores indicate greater impairment.
Baseline, Week 6, Week 12
Premenstrual Symptoms Screening Tool (PSST)
Periodo de tiempo: Baseline to Week 12
Within-participant change in PSST total score across 19 symptom items and 5 functional impact items. Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden.
Baseline to Week 12
BrainHQ Cognitive Assessment
Periodo de tiempo: Baseline to Week 12
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
Baseline to Week 12
Healthcare Resource Utilization (HCRU)
Periodo de tiempo: Baseline to Week 12
Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items.
Baseline to Week 12

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Numerical Rating Scale (NRS)
Periodo de tiempo: Baseline, Week 6, Week 12

Within-participant change in average pelvic or menstrual pain over the past 7 days.

Scored 0-10; higher scores indicate greater pain severity. MCID: 2 points. Exploratory outcome.
Baseline, Week 6, Week 12
Patient Global Impression of Change (PGIC)
Periodo de tiempo: Week 12
Participant-rated overall impression of change in hormonal health symptoms since study start. 7-point scale from Very much improved (1) to Very much worse (7). Exploratory.
Week 12
Net Promoter Score (NPS)
Periodo de tiempo: Week 12, Week 24
Participant likelihood to recommend the SGC program. Scored 0-10. Exploratory engagement metric for employer-facing reporting.
Week 12, Week 24
Clinical Global Impression of Severity (CGI-S)
Periodo de tiempo: Baseline

Clinician-rated impression of overall symptom severity at onboarding consultation.

7-point scale. Administered by contracted women's health clinician. Exploratory.
Baseline
Clinical Global Impression of Improvement (CGI-I)
Periodo de tiempo: Week 12

Clinician-rated impression of overall symptom improvement from baseline to end of program.

7-point scale. Administered by contracted women's health clinician. Exploratory.
Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Samphire Group, Inc.

Investigadores

  • Investigador principal: Nirav Shah, MD, MPH, Samphire Group, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2026

Publicado por primera vez (Actual)

1 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SAM-003

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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