Depression Scale ScoreNCT07172113
Utilizing Embodied Artificial Intelligence (AI) for the Development of Digital Cognitive Behavioral Therapy (CBT) for Depression in Virtual Reality (VR)
A study testing CBT + VR in people with Depression Scale Score, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Depression Scale Score
- What is being tested?
- CBT + VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Jan 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing Embodied Artificial Intelligence (AI) for the Development of Digital Cognitive Behavioral Therapy (CBT) for Depression in Virtual Reality (VR): a Pilot RCT
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
- Being tested
- CBT + VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month
Secondary outcomes (2)
The Satisfaction With Life Scale (SWLS)
The SWLS, containing 5 items, will be used to assess participants' life satisfaction. Items are scored based on a 7-point scale from strongly disagree (1) to strongly agree (7). A higher mean score indicates a greater satisfaction with life.
Measured: Baseline and 1 month
The revised General Help-Seeking Questionnaire (GHSQ)
The revised GHSQ contained first 10 questions from the original GHSQ, asking people's intention to seek help from various sources, and further incorporated 9 follow-up questions, asking people's attitude to seek help from various sources. All items are scored based on a 7-point scale, ranging from extremely unlikely (1) to extremely likely (7) for the first 10 intention-related items, and from extremely unhelpful (1) to extremely helpful (7) for the last 9 attitude-related items. A higher mean score indicates a greater intention and attitude to seek help.
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Jan 2025
- Primary completion17 Sep 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Scale ScoreStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim M. H. Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172113
- Sponsor's protocol ID
- 2024.061
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Embodied Artificial Intelligence (AI) for the Development of Digital Cognitive Behavioral Therapy (CBT) for Depression in Virtual Reality (VR): a Pilot RCT
- ClinicalTrials.gov ID
- NCT07172113
- Acronym / sponsor ID
- 2024.061
- Conditions
- Depression Scale Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: CBT + VRThe 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. |
| Control group | No intervention | –This group will serve as a waitlist control group. They will not receive the intervention until the study end. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT + VRThis 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. | Device | Intervention group |
Primary outcome
The Depression Subscale of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: Baseline and 1 month
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.
2 secondary outcomes
The Satisfaction With Life Scale (SWLS)
Time frame: Baseline and 1 month
The revised General Help-Seeking Questionnaire (GHSQ)
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT + VR in people with Depression Scale Score, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Depression Subscale of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.