Clinical trial NCT06735807: Generated AI-informed Intervention (Emohaa) vs Group ACT vs WL on Emotional Distress
Official title: Comparing Generated AI (Emohaa) and Group ACT in Reducing Emotional Distress: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence (AI)
Depression - Major Depressive Disorder
Anxiety
Lead sponsor: Central University of Finance and Economics, China
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: UCLA Loneliness Scale (ULS-3)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: Self-Concept Clarity Scale (SCCS)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: Acceptance and Action Questionnaire-2nd Edition (AAQ-II)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 0, 2, 4, 6, 8, and 10 weeks
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 2, 4, 6, 8, and 10 weeks
measure: Digital Working Alliance Inventory (DWAI)
timeFrame: 6, 8, and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Central University of Finance and Economics, China
Study officials:
References: