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Completed

NCT Number: NCT06735807

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

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.

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Key information

Conditions

Artificial Intelligence (AI) Anxiety Anxiety Disorders Depression - Major Depressive Disorder Mental Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central University of Finance and Economics, China

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generated AI-based intervention (Emohaa)

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

Behavioral

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

wailist (delayed intervenion)

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.

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.

  2. Generalized Anxiety Disorder (GAD-7)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    GAD-7 is an easy-to-perform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.

  3. UCLA Loneliness Scale (ULS-3)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    ULS-3 is a brief version of the UCLA Loneliness Scale with 3 items, which was designed to assess loneliness. Questions are scored on a Likert scale of 1-4 with 1 being never and 4 being always.

  4. Self-Concept Clarity Scale (SCCS)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    SCCS is a 12-item scale to measure the clarity of self-concept. Questions are scored on a Likert scale of 1-5 with 1 being strongly disagree and 5 being strongly agree.

  5. Acceptance and Action Questionnaire-2nd Edition (AAQ-II)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    AAQ-II is the second version of the Acceptance and Action Questionnaire with 7 items. Questions are scored on a Likert scale of 1-7 with 1 being never and 7 being always

  6. Insomnia Severity Index (ISI)

    Time frame: 0, 2, 4, 6, 8, and 10 weeks

    ISI is a 7-item screening tool to measure the severity of sleep problems. Questions are scored on a 0-4 scale with different descriptions

  7. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 2, 4, 6, 8, and 10 weeks

    CSQ-8 is an easy-to-perform initial screening tool for client satisfaction with mental health services. Questions are scored on a Likert scale of 1-4 with 1 being low satisfaction and 4 being high satisfaction.

  8. Digital Working Alliance Inventory (DWAI)

    Time frame: 6, 8, and 10 weeks

    DWAI is an 8-item scale to measure the working alliance between participants and the AI model revised by the Working Alliance Inventory. Questions are scored on a Likert scale of 1-7 with 1 being totally disagree and 7 being totally agree.

Sponsors and collaborators

Lead sponsor

Central University of Finance and Economics, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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