## Protocol Section
### Identification Module
**NCT ID:** NCT06418997

**Brief Title:** Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse

**Official Title:** Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse

#### Organization Study ID Info
**ID:** UP-23-00491
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
#### Secondary ID Infos
**ID:** R44MH132202
**Link:** https://reporter.nih.gov/quickSearch/R44MH132202
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Southern California

#### Responsible Party

**Investigator Affiliation:** University of Southern California

**Investigator Full Name:** Iony Ezawa

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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?

### Conditions Module

**Conditions:**

- Depression, Anxiety

**Keywords:**

- Metaverse

- virtual reality

- cognitive-behavioral

- depression

- depressive Disorders

- mental disorders

- skills group

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 306

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a virtual reality headset.

**Intervention Names:**

- Behavioral: CBI

**Label:** CBI-Virtual Reality

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a flat-screen device, such as a computer.

**Intervention Names:**

- Behavioral: CBI

**Label:** CBI-Flat Screen

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Participants randomized to this arm will be asked not to attend CBI sessions.

**Label:** Delayed-Access Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CBI-Flat Screen

- CBI-Virtual Reality

**Description:** 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.

**Name:** CBI

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure with strong psychometric properties that mirrors the nine criteria for evaluating whether someone meets criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV; American Psychiatric Association, 1994). Scores range from 0 to 27, with higher scores indicating great symptom severity.

**Measure:** Patient Health Questionnaire (PHQ-9)

**Time Frame:** Post-treatment (8-weeks) and follow-up (6-months)

#### Secondary Outcomes

**Description:** The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure with strong psychometric properties based on the diagnostic criteria for Generalized Anxiety Disorder (GAD-7) from the DSM-IV (American Psychiatric Association, 1994). Scores range from 0 to 21, with higher scores indicating great symptom severity.

**Measure:** Generalized Anxiety Disorder Questionnaire (GAD-7)

**Time Frame:** Post-treatment (8-weeks) and follow-up (6-months)

**Description:** The WHO QOL (Whoqol Group, 1998) is a 26-item self-report cross-cultural measure of quality of life within the domains of physical health, psychological health, social relationships, and environment. During the follow-up period, we will transition to using only the first item of the measure assessing overall quality of life. Scores are transformed on a scale from 0 to 100, with higher scores indicating a higher quality of life.

**Measure:** WHO Quality of Life-Brief (QOL)

**Time Frame:** Post-treatment (8-weeks) and 1-item version at follow-up (6-months)

### Eligibility Module

**Eligibility Criteria:** 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)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ezawa@usc.edu

**Name:** Iony D Ezawa, PhD

**Phone:** (213) 262-9992

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** ezawa@usc.edu

- **Name:** Iony D Ezawa, PhD

- **Phone:** 213-262-9992

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Southern California

**State:** California

**Status:** RECRUITING

**Zip:** 90089

#### Overall Officials

**Official 1:**

**Affiliation:** University of Southern California

**Name:** Iony D Ezawa, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364. Erratum In: JAMA Psychiatry. 2024 Mar 1;81(3):320.

**PMID:** 33471111

**Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

**PMID:** 11556941

**Citation:** Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

**PMID:** 16717171

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-31
