Generated AI-informed Intervention (Emohaa) vs Group ACT vs WL on Emotional Distress

NCT ID: NCT06735807

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2024-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Artificial Intelligence (AI) Depression - Major Depressive Disorder Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Generated AI (Emohaa)

Group Type EXPERIMENTAL

Generated AI-based intervention (Emohaa)

Intervention Type BEHAVIORAL

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 ACT

Group Type ACTIVE_COMPARATOR

group ACT

Intervention Type BEHAVIORAL

A 6-week group ACT intervention. Each group has 6-10 participants. Each session is one hour.

Waitlist Group (WLG)

Group Type SHAM_COMPARATOR

wailist (delayed intervenion)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

group ACT

A 6-week group ACT intervention. Each group has 6-10 participants. Each session is one hour.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central University of Finance and Economics, China

OTHER

Sponsor Role lead

Responsible Party

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Yi Feng

Associate Private Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central University of Finance and Economics, China

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CUFE-20240229-0001

Identifier Type: -

Identifier Source: org_study_id

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