Utilizing Embodied Artificial Intelligence (AI) for the Development of Digital Cognitive Behavioral Therapy (CBT) for Depression in Virtual Reality (VR)

NCT07172113 | Recruiting DMC

• 1 other identifier: 2024.061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a prevalent mental disorder characterized by pervasive low mood, diminished interest or pleasure, and a range of cognitive and physical symptoms. According to the World Health Organization (WHO), depression is a leading cause of disability worldwide, affecting approximately 280 million individuals of all ages. In spite of the widespread occurrence and negative consequences linked to depression, fewer than 30% of individuals with common mental disorders sought assistance from mental health services in the previous year due to reasons such as, high-cost and stigma. Cognitive behavioral therapy (CBT) is the gold-standard and evidence-based intervention for various mental health disorders, including depression, anxiety, and its effectiveness has been widely proven. With the recent advancement in AI and other relevant technologies, the use of digital CBT has become possible. Indeed, a recent systematic review demonstrated a comparable effectiveness of traditional CBT and digital CBT, after controlling the moderators (e.g., intervention duration, and adherence). While digital CBT has achieved impressive performance, the majority of them utilized web-based or app-based platforms. Therefore, one of the disadvantages of such digital CBT is the lack of interaction between (digital) therapists and clients. Additionally, lower adherence to digital interventions was observed, indicating the need for briefer sessions, such as single-session integrated CBT (SSI-CBT), for digital interventions. SSI-CBT involves a collaborative effort between the therapist and the client, aimed at assisting the client in accomplishing their desired outcome within a single session. It is understood that additional support is accessible if required. A recent study using SSI-CBT demonstrated promising results of its effectiveness in reducing depression and anxiety, which can last for two months. To further generalize the application of digital interventions, a more interactive virtual therapist utilizing a brief CBT-based intervention approach is desired. This study will evaluate the effectiveness of virtual CBT therapist for reducing depression symptoms, compared to a waitlist control group. Based on previous research, it is expected that a virtual CBT therapist can significantly reduce the depression symptoms at both post-intervention and one-month follow-up.

Conditions

Depression Scale Score

Outcome Measures

Primary Outcomes (1)

• The Depression Subscale of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

  The depression sub-scale of DASS-21 comprises seven items that are assessed on a 4-point Likert scale, ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much). The international cut-off values are as follows (as multiplication of sum by 2): 0-9 for normal, 10- 13 for mild, 14- 20 for moderate, 21- 27 for severe and 28 or above for extremely severe.

  Baseline and 1 month

Secondary Outcomes (2)

• The Satisfaction With Life Scale (SWLS)

  Baseline and 1 month

• The revised General Help-Seeking Questionnaire (GHSQ)

  Baseline and 1 month

Study Arms (2)

Intervention group

EXPERIMENTAL

The VR group will receive one session CBT via a VR headset. The session will last for around 45 mins. During the intervention, the participants can freely talk to the virtual therapist using natural language input.

Device: CBT + VR

Control group

NO INTERVENTION

This group will serve as a waitlist control group. They will not receive the intervention until the study end.

Interventions

CBT + VR DEVICE

This CBT intervention is conducted in VR using Embodied AI technology. A virtual therapist will present in a virtual therapy room. Participants can freely talk to and interactive with the virtual therapist.

Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese young adult aged 18-40 years
• Native Cantonese speaker
• Presence of depressive symptoms, as indicated by a score of 10 or higher on the depression sub-scale of the Depression Anxiety Stress Scale 21 (DASS-21).
• Able and willing to comply with the requirements of the study protocol

You may not qualify if:

• A current or history of any psychiatric disorder(s) other than depressive disorder and anxiety disorder, such as bipolar disorder, psychotic disorders, and substance use disorder
• A current or history of any voice, speech, and language disorders
• A current or history of non-suicidal self-injury or suicidality
• Incompetent in giving informed consent for participation in the study
• A current or history of significant motion sickness, active nausea, and vomiting or epilepsy.
• A current or history of color vision deficiency
• Subject who is preparing for pregnancy or pregnant

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: September 15, 2025
• Study Start: March 7, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

HK (1)