CES and EGChatbot in Reducing Anxiety, Depression, Insomnia, and Mental Risk
NCT Number: NCT06493695
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression, Anxiety
Interventions: BEHAVIORAL: Both EGChat and CES intervention|OTHER: Exercise Chatbot|DEVICE: CES (Cranial Electrotherapy Stimulation)
Sponsor: China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-30
Completion Date: 2027-04-30
Locations: China Medical University, Taichung, 40447, Taiwan

Summary:
The objective of this three-year study is to provide comprehensive care to young adults presenting with ARMS. The aim is use an exercise group (EGChat) developed by prior study and CES to decrease cognitive mental risks, improve emotional stability, enhance sleep quality, and elevate overall life satisfaction. A randomized controlled trial (RCT) design will be conducted using purposive sampling to recruit 180 young adults with ARMS from a medical center and its affiliated hospitals. Participants will be randomly assigned to one of three groups, undergoing a 16-week intervention: EGChat plus CES, EGChat without CES, or CES without EGChat groups. The study integrates the EGChat application into an online health promotion platform, coupled with CES intervention, to enhance the biological and psychological health of individuals at ARMS. The goal of this RCT study is to enhance the biological and psychological well-being of individuals with ARMS, covering exercise levels, Brain-Derived Neurotrophic Factor (BDNF) levels, health-promoting behaviors, metabolic indexes, cognitive mental risks, emotional status, sleep quality, and overall life quality. Assessments will occur at baseline (T0), 8 weeks into the intervention (T1), upon completion of the 16-week intervention (T2), and during a follow-up assessment at 3 months post-intervention (T3). The study will utilize generalized estimating equations (GEE) for mixed model repeated measures analysis to evaluate the significant influences of the intervention and interactions between study variables, utilizing group-time interaction.

Primary Outcome Measures: Levels of Cognitive Mental risk, Chinese Version of Schizotypal Personality Questionnaire-Brief (range from 0-114 scores) and Scale of Prodromal Symptoms (range from 0-22 scores)。Higher scores mean a higher cognitive risk., week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of State Anxiety and Trait Anxiety, Chinese Mandarin State-Trait Anxiety Inventory Form Y (range from 40-160 scores)。Higher scores mean a higher anxiety levels., week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of Depression, Taiwanese Depression Scale (range from 0-66 scores)。Higher scores mean a higher depression levels., week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of Sleep Quality, Pittsburgh Sleep Quality Index (range from 0-21 scores)。Higher scores mean a worse sleep problems., week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of Health-Promoting Lifestyle, Short Health-Promoting Lifestyle Profile checklist (range from 24-96 scores)。Higher scores mean a better health promotion lifestyle., week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Number of participants with Incidence of metabolic indicators, Metabolic and Physical Measures。Higher numbers of indicators mean a worse outcomes in metabolic health status., week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of Quality of Life Questionnaire, World Health Organization Quality of Life Assessment (range from 28-140 scores)。Higher scores mean a better lif quality., week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)|Levels of Exercise, 3-Month Physical Activity Checklist (self-report) and Actigraphy (Objective measure)。Higher scores mean a higher exercise levels., week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)