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

NCT07679074 · ctgov recruiting
Enrollment
50
Start
2026-06-01
Completion
2027-03-01
Last updated
2026-07-01
Has results
False
Countries
United States

Conditions

Premenstrual SyndromePremenstrual Dysphoric DisorderDysmenorrheaEndometriosisPerimenopauseMenopausePelvic Pain

Tagged with

endometriosis

Interventions

Eligibility criteria
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
License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine

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