Depression, Anxiety
Conditions
Keywords
Metaverse, virtual reality, cognitive-behavioral, depression, depressive Disorders, mental disorders, skills group
Brief summary
This study will test a new cognitive-behavioral skills training program (CBI) delivered in the metaverse. Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety, CBI's effectiveness compared to no intervention has yet to be determined. The intervention may be delivered through virtual reality as well as flat-screen devices, such as a computer, which may also affect CBI's effectiveness. The study will enroll up to 306 participants with depression. One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen device, and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial. For both CBI conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete brief weekly self-report questionnaires throughout their time in the study.
Detailed description
Cognitive behavioral therapy (CBT) is one of the most effective tools for the treatment of depression and anxiety. Despite its many strengths, CBT-based clinical care is often very expensive and difficult to access. To address problems of accessibility, the field is increasingly utilizing lay therapists (also commonly referred to as coaches or peers) to provide cognitive behavioral coaching. There is also accumulating evidence indicating that technology can be used to deliver affordable and accessible treatments with outcomes comparable to traditional face-to-face psychotherapy treatments (Karyotaki et al., 2021). In particular, the metaverse (Internet-connected 3-D virtual environments have also that allow end-users to interact as avatars) may be a distinctively powerful medium through which to deliver engaging, affordable, accessible, and scalable mental health interventions. In addition, the use of social virtual reality (VR) mental health interventions is relatively unexplored, yet the sense of presence ("being there") it provides may be useful to increase immersiveness in a digital intervention or facilitate social interaction in a digital space. Therefore, the investigators plan to conduct a randomized controlled trial on CBI in order to investigate its effectiveness among different groups of people and investigate the role immersive VR, as opposed to a flat screen, may play in predicting outcome measures. Upon joining the study, participants are asked to complete surveys once a week for 8 weeks and brief monthly follow-up surveys for 6 months. If you are randomized to either of the CBI conditions, you will also be asked to attend 8 weekly 1-hour sessions through a virtual application (from a VR headset or flat-screen, depending on your condition). This study seeks to address the main following research questions: (1) Is CBI efficacious? (and for whom is it more or less efficacious?) And (2) Does immersive VR confer any advantage over and above accessing CBI via less immersive flat screen devices?
Interventions
CBI sessions follow a detailed manual to teach a group of peers cognitive and behavioral strategies that they may utilize in their daily lives, often based around the cognitive-behavioral model as a teaching tool. CBI aims to develop cognitive-behaviorally-based skills and habits in participants, such as behavioral activation, mood tracking, the identification and reframing of automatic thoughts, and assertion training.
Sponsors
Study design
Eligibility
Inclusion criteria
* 18 years of age or older * Proficient in reading and speaking English * Have a computer with a stable internet connection * Score at or above the clinical threshold on the Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)
Exclusion criteria
* Sufficiently elevated levels of negative thoughts such that the individual is considered at high risk of harm, according to the Columbia Suicide Severity Rating Scale (CSSRS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | post-intervention week 8 | The Patient Health Questionnaire is a 9-item self-report measure of depression symptom severity. Scores range from 0 to 27, with higher scale scores indicating greater depression symptom severity. Scale scores were assessed and are presented for post-intervention week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 | post-intervention week 8 | The Generalized Anxiety Disorder-7 is a 7-item self-report measure of anxiety symptom severity. Scores range from 0 to 21, with higher scale scores indicating greater anxiety symptom severity. Scale scores were assessed and are presented for post-intervention week 8. |
| World Health Organization Quality of Life-General Scale | post-intervention week 8 | The World Health Organization Quality of Life - General scale is a 1-item self-report scale of general quality of life. Scores on this scale range from 0 to 100. Higher scores on this scale reflect a higher general quality of life. Scale scores were assessed and are presented for post-intervention week 8. |
Countries
United States
Contacts
University of Southern California
Participant flow
Recruitment details
Participants were recruited through posts on clinical trial registries, advertisements on social media apps, lab websites, and word of mouth. Participants were recruited from February 2024 to January 2025. The first intervention groups (8 weeks in duration) began in March 2024, and the final groups ended in March 2025 when the prespecified sample size was reached. Follow-up data (6 months in duration) were collected from May 2024 to September 2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.65 Years STANDARD_DEVIATION 13.38 |
| Generalized Anxiety Disorder-7 | 13.10 scores on a scale STANDARD_DEVIATION 4.85 |
| Patient Health Questionnaire-9 | 16.86 scores on a scale STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Asian | 62 Participants |
| Race/Ethnicity, Customized Black | 28 Participants |
| Race/Ethnicity, Customized Hispanic | 27 Participants |
| Race/Ethnicity, Customized Native American | 7 Participants |
| Race/Ethnicity, Customized Other | 11 Participants |
| Race/Ethnicity, Customized Pacific Islander | 5 Participants |
| Race/Ethnicity, Customized White | 156 Participants |
| Sex/Gender, Customized Female | 209 Participants |
| Sex/Gender, Customized Male | 31 Participants |
| Sex/Gender, Customized Not reported | 1 Participants |
| World Health Organization Quality of Life - General scale | 53.59 scores on a scale STANDARD_DEVIATION 21.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 0 / 102 | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 | 0 / 102 |