Depression, AnxietyNCT06493695
CES and EGChatbot in Reducing Anxiety, Depression, Insomnia, and Mental Risk
A study testing Both EGChat and CES intervention, Exercise Chatbot and CES (Cranial Electrotherapy Stimulation) in people with Depression, Anxiety, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Both EGChat and CES intervention, Exercise Chatbot and CES (Cranial Electrotherapy Stimulation)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Both EGChat and CES intervention, Exercise Chatbot, CES (Cranial Electrotherapy Stimulation)
- Keywords
- At-Risk Mental State, Exercise Chatbot, Cranial Electrotherapy Stimulation, Cognitive Mental Risks, Emotional Distress, Anxiety, Depression, Insomnia, Quality of Life
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Both EGChat and CES interventionBehavioural
Also called EGChat and CES intervention
- A exercise-promoting chatbot called EGChat, integrated into an established online health promotion platform.
- Intervention of CES (Cranial Electrotherapy Stimulation) at Home
Exercise ChatbotOther
Exercise Chatbot
CES (Cranial Electrotherapy Stimulation)Device
Intervention of CES (Cranial Electrotherapy Stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Chatbot & CES | Experimental | Exercise Chatbot intervention with Cranial Electrical Stimulation intervention Receives: Behavioral: Both EGChat and CES intervention |
| Chatbot | Experimental | Exercise Chatbot intervention without Cranial Electrical Stimulation intervention Receives: Other: Exercise Chatbot |
| CES | Experimental | Cranial Electrical Stimulation intervention without Exercise Chatbot intervention Receives: Device: CES (Cranial Electrotherapy Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 0 (before interventions), weeks 16 (after interventions), 3 months follow-up (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized controlled experimental design with three groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Fen Ma, PHD, Principal investigator, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493695
- Sponsor's protocol ID
- CMUH113-REC3-050
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrical Stimulation and Exercise Group Chatbot
- ClinicalTrials.gov ID
- NCT06493695
- Acronym / sponsor ID
- CMUH113-REC3-050
- Conditions
- Depression, Anxiety
- Keywords
- At-Risk Mental State, Exercise Chatbot, Cranial Electrotherapy Stimulation, Cognitive Mental Risks, Emotional Distress, Anxiety, Depression, Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- a randomized controlled experimental design with three groups
| Arm | Type | Receives |
|---|---|---|
| Chatbot & CES | Experimental | Behavioral: Both EGChat and CES interventionExercise Chatbot intervention with Cranial Electrical Stimulation intervention |
| Chatbot | Experimental | Other: Exercise ChatbotExercise Chatbot intervention without Cranial Electrical Stimulation intervention |
| CES | Experimental | Device: CES (Cranial Electrotherapy Stimulation)Cranial Electrical Stimulation intervention without Exercise Chatbot intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Both EGChat and CES interventionAlso: EGChat and CES intervention1. A exercise-promoting chatbot called EGChat, integrated into an established online health promotion platform. 2. Intervention of CES (Cranial Electrotherapy Stimulation) at Home | Behavioural | Chatbot & CES |
| Exercise ChatbotExercise Chatbot | Other | Chatbot |
| CES (Cranial Electrotherapy Stimulation)Intervention of CES (Cranial Electrotherapy Stimulation) | Device | CES |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-Fen Ma, PHD principal investigator
School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Both EGChat and CES intervention, Exercise Chatbot and CES (Cranial Electrotherapy Stimulation) in people with Depression, Anxiety, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Fen Ma, PHD (04 22053366 ext. 7107, lhdaisy@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.