A 12-Week Digital Health Program Evaluating Samphire Guided Care on Work Productivity, Wellbeing, and Quality of Life in Women with Menstrual and Menopausal Symptoms

What this Trial Is About

Researchers are evaluating the Samphire Guided Care SGC program, a 12-week digital health initiative designed for women experiencing mood and cognitive symptoms related to menstruation, perimenopause, or menopause. This observational study aims to understand the programs impact on work productivity, employee wellbeing, and quality of life. The study is conducted fully remotely, allowing participants to engage from home without randomization or placebo comparison. The SGC program includes a clinician-led eligibility assessment, at-home use of the Lutea transcranial direct current stimulation tDCS device for neuromodulation for those eligible and who opt in, neuromodulation coach support, and app-based symptom tracking. Participants are divided into two groups based on device use and adherence one group completes at least 30% of recommended tDCS sessions, while the other group either declines the device or has lower engagement. Both groups follow the same assessment schedule throughout the 12 weeks. Participants complete questionnaires and cognitive assessments at the start, middle, and end of the program. Data collection includes work productivity, wellbeing indices, mood, anxiety, sleep quality, premenstrual symptoms, cognitive function, pain levels, healthcare resource use, and clinician-rated scales. All activities are managed through a digital platform, and electronic informed consent is obtained before participation. The study spans 12 weeks, with continuous monitoring and support throughout this period.

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