NCT06735807

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

Comparing Generated AI (Emohaa) and Group ACT in Reducing Emotional Distress: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Central University of Finance and Economics, China · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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). 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.

Conditions

• Artificial Intelligence (AI)
• Depression - Major Depressive Disorder
• Anxiety

Interventions

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

Timeline

• Start date: 2024-09-20
• Primary completion: 2024-12-20
• Completion: 2024-12-28
• First posted: 2024-12-16
• Last updated: 2025-04-25

Locations

1 site across 1 country: China