Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation
NCT Number: NCT06470425
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Disorder
Interventions: OTHER: Standard therapy group|OTHER: AI-Guided group
Sponsor: S.LAB (SOLOWAYS)
Collaborators: Triangel Scientific|Center of New Medical Technologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-02
Completion Date: 2024-06-01
Locations: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation

Summary:
The study "Optimizing Mental Health Management with AI-Guided (GenAIS TM) Dietary Supplementation" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing mental health disorders, specifically depression and anxiety. This 6-month randomized controlled trial included 160 participants diagnosed with major depressive disorder or generalized anxiety disorder. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in mental health scores, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.

Primary Outcome Measures: The primary endpoint is the percent change in mental health scores (Hamilton Depression Rating Scale, Generalized Anxiety Disorder 7-item scale) for the AI-Guided group compared with the Control group., The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered assessment used to measure the severity of depression in individuals. It consists of 17 to 21 items, with each item scored on a scale of 0 to 4 or 0 to 2.

The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-administered questionnaire used to screen for and measure the severity of generalized anxiety disorder. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day), with the total score ranging from 0 to 21. Higher scores indicate greater anxiety severity., 6 months
Secondary Outcome Measures: Percent change in specific symptoms of depression and anxiety., 6 months|Percent change in high-sensitivity C-reactive protein (hsCRP)., 6 months|Percent change in body weight and BMI., 6 months|Incidence of adverse effects related to dietary supplements., 6 months|Participant adherence to the prescribed dietary supplements regimen., 6 months|Changes in quality of life score SF-36, Short Form (SF-36) Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being., 6 months|Changes in quality of life score WHOQOL-BREF, World Health Organization Quality of Life - BREF (WHOQOL-BREF), which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life., 6 months