Clinical trial NCT06992180: Generative Artificial Intelligence Intervention and Individual Psychological Counseling on Emotional Distress in Young Adults
Official title: The Intervention Effect of Generative Artificial Intelligence (Emohaa) and Individual Psychological Counseling on Emotional Distress in Young Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Keywords: Depression
anxiety
Lead sponsor: Central University of Finance and Economics, China
Sponsor class: OTHER
Collaborators: name: Beijing Normal University
name: China Agricultural University
name: Qinghai University
First posted: 2025-05-28
Enrollment: 222
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This three-arm randomized controlled trial will investigate the efficacy of Emohaa, a generative artificial intelligence (AI)-based chatbot designed to deliver empathetic conversational support to young adults experiencing emotional distress. The study will enroll 222 participants, randomly allocated (1:1:1) into one of the following arms:

AI Chatbot Group: 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.

Traditional Counseling Group: 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).

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

Assessment Schedule and Outcome Measures

Data will be collected via Wenjuanxing online survey links at six time points:

T1: Baseline (before intervention)

T2: After session 2

T3: After session 4

T4: Post-intervention (after session 6)

T5: 2-week follow-up

T6: 1-month follow-up

All outcome measures are validated self-report instruments with established psychometric properties in Chinese populations.

Primary Outcomes (T1-T6) PHQ-9: Patient Health Questionnaire for depressive symptoms

GAD-7: Generalized Anxiety Disorder Scale

ISI: Insomnia Severity Index (7 items)

Academic Burnout Scale (6 items)

Secondary Outcomes (T1-T6) ERQ: Emotion Regulation Questionnaire (10 items)

Loneliness Scale (3 items)

IUS-12: Intolerance of Uncertainty Scale

PSS-10: Perceived Stress Scale

GESS: General Self-Efficacy Scale (10 items)

Additional Measures (T2-T6) CSQ-8: Client Satisfaction Questionnaire

DWAI: Digital Working Alliance Inventory

Data Quality and Collection Procedures All data will be collected electronically using Wenjuanxing (问卷星), which provides timestamped, secure survey distribution and response logging. Participants will receive automatic reminders prior to each time point. The data collection team will perform regular checks to detect and manage missing or inconsistent entries.

To ensure the reliability and validity of the data collection process:

All measurement instruments are widely used, psychometrically validated scales in Chinese.

Survey completion will be monitored in real time.

Study staff will be trained in participant guidance and data integrity monitoring procedures.

Duplicate entries will be flagged using participant ID and contact verification protocols.

Random audits and outlier checks will be conducted at each time point to ensure data quality.

Eligibility criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Depression
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: Anxiety
timeFrame: From enrollment to the end of treatment at 10 weeks
Secondary outcomes:
measure: Loneliness
timeFrame: From enrollment to the end of treatment at 10 weeks
Other outcomes:
measure: Satisfaction with the GAI intervention
timeFrame: From first GAI intervention to the end of treatment at 10 weeks
Locations:
Study officials:
affiliation: Beijing Normal University
name: Zhihong Qiao, Doctor
role: STUDY_DIRECTOR
References: