CES and EGChatbot in Reducing Anxiety, Depression, Insomnia, and Mental Risk

NCT06493695 | Not Yet Recruiting DMC

• 1 other identifier: CMUH113-REC3-050
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Anxiety

Keywords

At-Risk Mental State; Exercise Chatbot; Cranial Electrotherapy Stimulation; Cognitive Mental Risks; Emotional Distress; Anxiety; Depression; Insomnia; Quality of Life

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (3)

Chatbot & CES

EXPERIMENTAL

Exercise Chatbot intervention with Cranial Electrical Stimulation intervention

Behavioral: Both EGChat and CES intervention

Chatbot

EXPERIMENTAL

Exercise Chatbot intervention without Cranial Electrical Stimulation intervention

Other: Exercise Chatbot

CES

EXPERIMENTAL

Cranial Electrical Stimulation intervention without Exercise Chatbot intervention

Device: CES (Cranial Electrotherapy Stimulation)

Interventions

Both EGChat and CES intervention BEHAVIORAL

1. A exercise-promoting chatbot called EGChat, integrated into an established online health promotion platform. 2. Intervention of CES (Cranial Electrotherapy Stimulation) at Home

Also known as: EGChat and CES intervention

Chatbot & CES

Exercise Chatbot OTHER

Exercise Chatbot

Chatbot

CES (Cranial Electrotherapy Stimulation) DEVICE

Intervention of CES (Cranial Electrotherapy Stimulation)

CES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 65 years old
• meet the DSM-5 criteria for ARMS as assessed by psychiatrists, who serve as the Co-PI of this research
• exhibit persistent symptoms without clinically significant fluctuations
• consent to participate in the study and provide written informed consent.

You may not qualify if:

• have a DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
• possess a history of epilepsy, head trauma, central nervous system diseases, or frequent syncope
• are pregnant or lactating
• have an implanted neurostimulator or cardiac pacemaker
• have metal implants in the body
• non-removable cochlear implant
• are unable to adhere to the protocol (including the absence of a computer, tablet, or smartphone for use)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Wei-Fen Ma, PHD

  School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Fen Ma, PHD

CONTACT

04 22053366; lhdaisy@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized controlled experimental design with three groups

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 10, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)