Artificial Intelligence (AI)NCT06735807
Generated AI-informed Intervention (Emohaa) vs Group ACT vs WL on Emotional Distress
A study testing Generated AI-based intervention (Emohaa), group ACT and wailist (delayed intervenion) in people with Artificial Intelligence (AI) and Depression - Major Depressive Disorder, run by Central University of Finance and Economics, China at 1 site in China.
Trial summary
Emotional Distress, such as anxiety and depression, is an essential issue worldwide. There have been several evidence-based psychotherapies that are effective in improving emotional distress, such as Acceptance and Commitment Therapy (ACT). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence (AI), Depression - Major Depressive Disorder, Anxiety
- What is being tested?
- Generated AI-based intervention (Emohaa), group ACT and wailist (delayed intervenion)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults with 18-25 ages;
- Suffering from emotional distress (PHQ-9 > 9 or GAD-7 > 9);
- Ability to use the mobile phone to interact with AI;
- Consent to participate in the study.
Who cannot join
- High risk of self-injury and suicide;
- Presence of psychotic symptoms (i.e., delusions);
- Serious substance use problems;
- Other mental or physical illnesses requiring urgent medical assistance;
- Received other psychological or pharmacological interventions in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Generated AI (Emohaa) and Group ACT in Reducing Emotional Distress: a Randomized Controlled Trial
Emotional Distress, such as anxiety and depression, is an essential issue worldwide. There have been several evidence-based psychotherapies that are effective in improving emotional distress, such as Acceptance and Commitment Therapy (ACT). However, the scarcity of professionals and the imbalance in the distribution of mental health resources prevent individuals in need from accessing immediate and effective help.
Artificial intelligence (AI) has the potential to promote this problem. The existing studies have provided preliminary support for the application of AI in mental health interventions. One such model, Emohaa, a generated AI model, has been examined for its effectiveness in adult emotional distress. However, despite the limited reliability of the single-group design, parallel randomized controlled trials are scarce to validate this finding further. This present study is to fill this gap.
This study aims to examine the effectiveness of the generated AI (Emohaa) in reducing emotional distress, including anxiety and depression, compared with group ACT and waitlist. In this parallel randomized controlled trial, it is hypothesized that (1) Compared with the waitlist, Emohaa and group ACT could significantly improve participants' emotional distress, including anxiety and depression symptoms; (2) Emohaa would lead to a greater reduction in anxiety and depression symptoms compared with group ACT.
- Being tested
- Generated AI-based intervention (Emohaa), group ACT, wailist (delayed intervenion)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generated AI-based intervention (Emohaa)Behavioural
Participants will complete the intervention process by interacting with the Wechat applet. Participants will be required to complete a 6-week self-help therapy. Participants will be required to have a 30-minute dialogue including input and reflection time with Emohaa each week simultaneously with group ACT. Participants are free to dialogue with Emohaa for the rest of the week. An independent research assistant will monitor the intervention process from the platform. If the corresponding dialogue is not completed on time each week, the participant will be reminded via WeChat to complete this session before the start of the next session in the following week.
group ACTBehavioural
A 6-week group ACT intervention. Each group has 6-10 participants. Each session is one hour.
wailist (delayed intervenion)Behavioural
During the intervention period, participants in the WLG were only required to complete the appropriate assessments without receiving any intervention. Upon completion of the 15-day follow-up assessment, participants in the WLG could be free to choose to receive one of the two interventions. The intervention will be the same as the corresponding experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Generated AI (Emohaa) | Experimental | Not described Receives: Behavioral: Generated AI-based intervention (Emohaa) |
| Group ACT | Active comparator | Not described Receives: Behavioral: group ACT |
| Waitlist Group (WLG) | Sham comparator | Not described Receives: Behavioral: wailist (delayed intervenion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Measured: 0, 2, 4, 6, 8, and 10 weeks
Generalized Anxiety Disorder (GAD-7)
GAD-7 is an easy-to-perform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Measured: 0, 2, 4, 6, 8, and 10 weeks
UCLA Loneliness Scale (ULS-3)
ULS-3 is a brief version of the UCLA Loneliness Scale with 3 items, which was designed to assess loneliness. Questions are scored on a Likert scale of 1-4 with 1 being never and 4 being always.
Measured: 0, 2, 4, 6, 8, and 10 weeks
Self-Concept Clarity Scale (SCCS)
SCCS is a 12-item scale to measure the clarity of self-concept. Questions are scored on a Likert scale of 1-5 with 1 being strongly disagree and 5 being strongly agree.
Measured: 0, 2, 4, 6, 8, and 10 weeks
Acceptance and Action Questionnaire-2nd Edition (AAQ-II)
AAQ-II is the second version of the Acceptance and Action Questionnaire with 7 items. Questions are scored on a Likert scale of 1-7 with 1 being never and 7 being always
Measured: 0, 2, 4, 6, 8, and 10 weeks
Insomnia Severity Index (ISI)
ISI is a 7-item screening tool to measure the severity of sleep problems. Questions are scored on a 0-4 scale with different descriptions
Measured: 0, 2, 4, 6, 8, and 10 weeks
Client Satisfaction Questionnaire (CSQ-8)
CSQ-8 is an easy-to-perform initial screening tool for client satisfaction with mental health services. Questions are scored on a Likert scale of 1-4 with 1 being low satisfaction and 4 being high satisfaction.
Measured: 2, 4, 6, 8, and 10 weeks
Digital Working Alliance Inventory (DWAI)
DWAI is an 8-item scale to measure the working alliance between participants and the AI model revised by the Working Alliance Inventory. Questions are scored on a Likert scale of 1-7 with 1 being totally disagree and 7 being totally agree.
Measured: 6, 8, and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Sep 2024
- Primary completion20 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central University of Finance and Economics, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, Central University of Finance and Economics, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735807
- Sponsor's protocol ID
- CUFE-20240229-0001
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal contact in reliable reason
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Generated AI (Emohaa) and Group ACT in Reducing Emotional Distress: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06735807
- Acronym / sponsor ID
- CUFE-20240229-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central University of Finance and Economics, ChinaUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 16 Dec 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.
Emotional Distress, such as anxiety and depression, is an essential issue worldwide. There have been several evidence-based psychotherapies that are effective in improving emotional distress, such as Acceptance and Commitment Therapy (ACT). However, the scarcity of professionals and the imbalance in the distribution of mental health resources prevent individuals in need from accessing immediate and effective help.
Artificial intelligence (AI) has the potential to promote this problem. The existing studies have provided preliminary support for the application of AI in mental health interventions. One such model, Emohaa, a generated AI model, has been examined for its effectiveness in adult emotional distress. However, despite the limited reliability of the single-group design, parallel randomized controlled trials are scarce to validate this finding further. This present study is to fill this gap.
This study aims to examine the effectiveness of the generated AI (Emohaa) in reducing emotional distress, including anxiety and depression, compared with group ACT and waitlist. In this parallel randomized controlled trial, it is hypothesized that (1) Compared with the waitlist, Emohaa and group ACT could significantly improve participants' emotional distress, including anxiety and depression symptoms; (2) Emohaa would lead to a greater reduction in anxiety and depression symptoms compared with group ACT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generated AI (Emohaa) | Experimental | Behavioral: Generated AI-based intervention (Emohaa) |
| Group ACT | Active comparator | Behavioral: group ACT |
| Waitlist Group (WLG) | Sham comparator | Behavioral: wailist (delayed intervenion) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults with 18-25 ages;
- Suffering from emotional distress (PHQ-9 > 9 or GAD-7 > 9);
- Ability to use the mobile phone to interact with AI;
- Consent to participate in the study.
Key exclusion criteria (5 listed)
- High risk of self-injury and suicide;
- Presence of psychotic symptoms (i.e., delusions);
- Serious substance use problems;
- Other mental or physical illnesses requiring urgent medical assistance;
- Received other psychological or pharmacological interventions in the last month
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 |
|---|---|---|
| Generated AI-based intervention (Emohaa)Participants will complete the intervention process by interacting with the Wechat applet. Participants will be required to complete a 6-week self-help therapy. Participants will be required to have a 30-minute dialogue including input and reflection time with Emohaa each week simultaneously with group ACT. Participants are free to dialogue with Emohaa for the rest of the week. An independent research assistant will monitor the intervention process from the platform. If the corresponding dialogue is not completed on time each week, the participant will be reminded via WeChat to complete this session before the start of the next session in the following week. | Behavioural | Generated AI (Emohaa) |
| group ACTA 6-week group ACT intervention. Each group has 6-10 participants. Each session is one hour. | Behavioural | Group ACT |
| wailist (delayed intervenion)During the intervention period, participants in the WLG were only required to complete the appropriate assessments without receiving any intervention. Upon completion of the 15-day follow-up assessment, participants in the WLG could be free to choose to receive one of the two interventions. The intervention will be the same as the corresponding experimental group. | Behavioural | Waitlist Group (WLG) |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Generalized Anxiety Disorder (GAD-7)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
GAD-7 is an easy-to-perform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
UCLA Loneliness Scale (ULS-3)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
ULS-3 is a brief version of the UCLA Loneliness Scale with 3 items, which was designed to assess loneliness. Questions are scored on a Likert scale of 1-4 with 1 being never and 4 being always.
Self-Concept Clarity Scale (SCCS)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
SCCS is a 12-item scale to measure the clarity of self-concept. Questions are scored on a Likert scale of 1-5 with 1 being strongly disagree and 5 being strongly agree.
Acceptance and Action Questionnaire-2nd Edition (AAQ-II)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
AAQ-II is the second version of the Acceptance and Action Questionnaire with 7 items. Questions are scored on a Likert scale of 1-7 with 1 being never and 7 being always
Insomnia Severity Index (ISI)
Time frame: 0, 2, 4, 6, 8, and 10 weeks
ISI is a 7-item screening tool to measure the severity of sleep problems. Questions are scored on a 0-4 scale with different descriptions
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 2, 4, 6, 8, and 10 weeks
CSQ-8 is an easy-to-perform initial screening tool for client satisfaction with mental health services. Questions are scored on a Likert scale of 1-4 with 1 being low satisfaction and 4 being high satisfaction.
Digital Working Alliance Inventory (DWAI)
Time frame: 6, 8, and 10 weeks
DWAI is an 8-item scale to measure the working alliance between participants and the AI model revised by the Working Alliance Inventory. Questions are scored on a Likert scale of 1-7 with 1 being totally disagree and 7 being totally agree.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Personal contact in reliable reason
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generated AI-based intervention (Emohaa), group ACT and wailist (delayed intervenion) in people with Artificial Intelligence (AI) and Depression - Major Depressive Disorder, run by Central University of Finance and Economics, China at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 25 Apr 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: 0, 2, 4, 6, 8, and 10 weeks). 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 25 Apr 2025.