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

NCT ID: NCT06493695

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-04-30

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.

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Chatbot & CES

Exercise Chatbot intervention with Cranial Electrical Stimulation intervention

Group Type: EXPERIMENTAL

Both EGChat and CES intervention

Intervention Type: 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

Chatbot

Exercise Chatbot intervention without Cranial Electrical Stimulation intervention

Group Type: EXPERIMENTAL

Exercise Chatbot

Intervention Type: OTHER

Exercise Chatbot

CES

Cranial Electrical Stimulation intervention without Exercise Chatbot intervention

Group Type: EXPERIMENTAL

CES (Cranial Electrotherapy Stimulation)

Intervention Type: DEVICE

Intervention of CES (Cranial Electrotherapy Stimulation)

Interventions

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

Intervention Type: BEHAVIORAL

Exercise Chatbot

Exercise Chatbot

Intervention Type: OTHER

CES (Cranial Electrotherapy Stimulation)

Intervention of CES (Cranial Electrotherapy Stimulation)

Intervention Type: DEVICE

Other Intervention Names

EGChat and CES intervention

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Fen Ma, PHD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing

Locations

China Medical University

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Wei-Fen Ma, PHD

Role: CONTACT

lhdaisy@mail.cmu.edu.tw

04 22053366 ext. 7107

Other Identifiers

CMUH113-REC3-050

Identifier Type: -

Identifier Source: org_study_id