Generative Artificial Intelligence Intervention and Individual Psychological Counseling on Emotional Distress in Young Adults

NCT06992180 | Not Yet Recruiting

• 1 other identifier: CUFE-20260518
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. A total of 222 participants will be randomly assigned to one of three groups: (1) AI chatbot intervention, (2) traditional counseling, or (3) waitlist control. The study spans six time points from baseline through one-month follow-up. Primary and secondary outcomes will be measured via validated self-report questionnaires. The intervention is delivered entirely online through a WeChat-integrated platform, ensuring high accessibility and scalability.

Conditions

Depression, Anxiety

Keywords

Depression; anxiety

Outcome Measures

Primary Outcomes (2)

• Depression

  The Patient Health Questionnaire-9 (PHQ-9) was employed in this study to measure depressive symptoms. This scale consists of 9 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with scores of 0-4 indicating no depressive symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe depressive symptoms. Previous research has demonstrated good reliability and validity for the Chinese version of the PHQ-9.

  From enrollment to the end of treatment at 10 weeks

• Anxiety

  The Generalized Anxiety Disorder-7 (GAD-7) was used to assess anxiety symptoms in this study. This scale consists of 7 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with scores of 0-4 indicating no anxiety symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe anxiety symptoms. Prior studies have shown that the Chinese version of the GAD-7 has good reliability and validity.

  From enrollment to the end of treatment at 10 weeks

Secondary Outcomes (1)

• Loneliness

  From enrollment to the end of treatment at 10 weeks

Other Outcomes (1)

• Satisfaction with the GAI intervention

  From first GAI intervention to the end of treatment at 10 weeks

Study Arms (3)

Generative Artificial Intelligence Intervention Group

EXPERIMENTAL

Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support.

Behavioral: Generative Artificial Intelligence Intervention

Individual Psychological Counseling Group

EXPERIMENTAL

Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT).

Behavioral: Individual Psychological Counseling

Waiting List Group

NO INTERVENTION

Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion.

Interventions

Generative Artificial Intelligence Intervention BEHAVIORAL

The intervention is delivered via a generative artificial intelligence platform called Emohaa. Participants will register and gain access to the platform prior to the start of the trial. Emohaa's responses are based on Hill's helping skills theory in psychology and are designed to simulate the basic communication strategies of a human counselor. The system demonstrates strong capabilities in active listening, emotional mirroring, and empathy, supporting users in understanding their own thoughts and feelings, learning to cope with emotional challenges, and achieving a more optimistic and positive mental and emotional state.

Generative Artificial Intelligence Intervention Group

Individual Psychological Counseling BEHAVIORAL

Participants in the traditional counseling group will receive individual psychological counseling sessions conducted by certified psychotherapists.

Individual Psychological Counseling Group

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ranges from 15 to 30
• Suffering from emotional distress (PHQ-9 \> 14 or GAD-7 \> 12)
• Ability to use the mobile phone to interact with AI
• Consent to participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central University of Finance and Economics, China: lead
• Beijing Normal University: collaborator
• China Agricultural University: collaborator
• Qinghai University: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Zhihong Qiao, Doctor

  Beijing Normal University

  STUDY DIRECTOR

Central Study Contacts

Yi Feng, Ph.D

CONTACT

+86 17806250621; 202331061027@mail.bnu.edu.cn

Wenzhi Wu, Master

CONTACT

+86 18810919931; wenzhi4913@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate researcher

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 28, 2025
• Study Start: May 20, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 10, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share