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

Central University of Finance and Economics, China

Status: Completed

Conditions: Anxiety; Depression - Major Depressive Disorder; Artificial Intelligence (AI)

Treatments: Behavioral: Generated AI-based intervention (Emohaa); Behavioral: group ACT; Behavioral: wailist (delayed intervenion)

Study type: Interventional

Funder types: Other

Identifiers

NCT06735807

CUFE-20240229-0001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Generated AI (Emohaa)

Experimental group

Treatment:

Behavioral: Generated AI-based intervention (Emohaa)

Group ACT

Active Comparator group

Treatment:

Behavioral: group ACT

Waitlist Group (WLG)

Sham Comparator group

Treatment:

Behavioral: wailist (delayed intervenion)