Anxiety, Artificial Intelligence (AI), Depression - Major Depressive Disorder
Conditions
Brief 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.
Interventions
BEHAVIORALGenerated 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.
BEHAVIORALgroup ACT
A 6-week group ACT intervention. Each group has 6-10 participants. Each session is one hour.
BEHAVIORALwailist (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.
Sponsors
Central University of Finance and Economics, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 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. |
| Generalized Anxiety Disorder (GAD-7) | 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. |
| UCLA Loneliness Scale (ULS-3) | 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. |
| Self-Concept Clarity Scale (SCCS) | 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. |
| Acceptance and Action Questionnaire-2nd Edition (AAQ-II) | 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 |
| Insomnia Severity Index (ISI) | 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 |
| Client Satisfaction Questionnaire (CSQ-8) | 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. |
| Digital Working Alliance Inventory (DWAI) | 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. |
Countries
China
Outcome results
None listed