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

July 9, 2024 updated by: China Medical University Hospital

Cranial Electrical Stimulation and Exercise Group Chatbot

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In our previous study, the two-year psychosis transition rate was 8.33%, comparatively lower than rates reported in other international studies. Our findings highlight that individuals in the at-risk mental state (ARMS) category face cognitive, emotional, and sleep-related challenges, leading to compromised self-identity and impairments in daily functioning. A significant proportion of young adults at risk of mental health issues not only display cognitive vulnerabilities but also endure emotional instability and sleep disturbances, increasing the likelihood of suicidal ideation and persistent self-harming behaviors. It's clear that individuals facing mental health challenges, especially those with ARMS, require support from the health system. Exercise has been linked to enhanced cognitive function and mental health. The mental health chatbot as a promising tool for adolescents and young adults in the ARMS, showing potential in alleviating anxiety, depression, and mental health risks. Additionally, cranial electrotherapy stimulation (CES) is recommended as a safe and effective approach to address sleep-related problems. Together, these interventions may be proposed as a comprehensive care strategy, providing secure support for individuals with ARMS.

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. Additionally, a machine-learning framework for EGChat will be implemented to enhance outcome predictions. The analysis of these machine-learning algorithms will be conducted using the WEKA software.

Comprehensive care intervention programs for individuals with ARMS should address the management of cognitive mental risks, anxiety, depression, and insomnia. The study findings provide evidence supporting the effectiveness of EGChat and CES in assisting young adults with ARMS. The ultimate goals are to achieve early intervention, delay the onset of psychosis, impede disease progression, and enhance the patient's capacity for self-management and societal adaptation.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chatbot & CES
Exercise Chatbot intervention with Cranial Electrical Stimulation intervention
Behavioral: Both EGChat and CES intervention
  1. A exercise-promoting chatbot called EGChat, integrated into an established online health promotion platform.
  2. Intervention of CES (Cranial Electrotherapy Stimulation) at Home
Other Names:
  • EGChat and CES intervention
Experimental: Chatbot
Exercise Chatbot intervention without Cranial Electrical Stimulation intervention
Other: Exercise Chatbot
Exercise Chatbot
Experimental: CES
Cranial Electrical Stimulation intervention without Exercise Chatbot intervention
Device: CES (Cranial Electrotherapy Stimulation)
Intervention of CES (Cranial Electrotherapy Stimulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of Cognitive Mental risk
Time Frame: week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 8 (in the middle of 16 weeks interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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
Time Frame: week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Wei-Fen Ma, PHD, School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH113-REC3-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Anxiety

Clinical Trials on Both EGChat and CES intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe