Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)

Anxiety Disorders Clinical Trial

Official title:

Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)- Resilience Training in Virtual Reality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360562
• Other study ID #: 2020P002418
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: April 25, 2025

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Daphne J Holt, MD, PhD
• Phone: 617-726-7618
• Email: dholt[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: April 25, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion criteria for college student participants:

1. 18-30 years old

2. Enrolled in an undergraduate program

Inclusion criteria for healthcare provider participants:

1. At least 18 years old

2. Employed in the healthcare field with some direct patient contact

Exclusion Criteria:

1. Inability to provide informed consent

2. Not proficient in English

3. Acute symptoms of a psychiatric illness needing immediate care (such as acute psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by self-report that necessitates close monitoring or inpatient or partial hospitalization.

4. Enrolled in current psychotherapy with frequency of more than once per month

Related Conditions & MeSH terms

• Anxiety Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Resilience Training
Behavioral group-based intervention delivering mindfulness, metallization, and self-compassion skills.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort with Others	Discomfort with others is measured on a brief scale rated on a Likert scale of 1-5, asking three questions, how frequently someone feels discomfort with others, how intensely they feel it, and a multiple choice selection of reasons they may feel discomfort with others. Higher ratings indicate more discomfort with others.	Before the intervention, 6 weeks later, and 6 months later
Primary	Intervention Feasibility and Acceptability	This measure includes participant attendance, with more attendance of the intervention indicating better feasibility and acceptability.	Before the intervention, 6 weeks later, and 6 months later
Primary	Penn Emotion Recognition Test	The Penn Emotion Recognition Test (ER-40) is a 15-minute computer task which involves identifying the emotion (sadness, anger, etc.) expressed by a variety of face images with 5 possible options, was used to measure emotion recognition ability. The total score ranges from 0-40, with individual sub-scores for happy, sad, angry, fearful, and neutral expressions.	Before the intervention, 6 weeks later, and 6 months later
Primary	Stop Distance Paradigm	The Stop Distance Paradigm is a reliable way to measure ones personal space. The larger the number, the larger the person stands from others. This scale is rated by centimeters from zero (no personal space) to as many as the person chooses. This task was done in person, through Zoom, and in virtual reality.	Before the intervention, 6 weeks later, and 6 months later
Secondary	Beck Depression Inventory	The Beck Depression Inventory (BDI) is a 21-item self-report assessment obtaining ratings of one's level of depression on a Likert scale of 0-63, with higher scores indicating more depressive symptoms.	Before the intervention, 6 weeks later, and 6 months later
Secondary	Spielberger State-Trait Anxiety Inventory	The Spielberger State-Trait Anxiety Inventory (STAI) is a 20-item self-report scale obtaining ratings of one's anxiety, both those that are trait like and ongoing, and those that are state like and temporary. Scores range from 0-120, with higher scores indicate higher levels of anxiety symptoms.	Before the intervention, 6 weeks later, and 6 months later
Secondary	Prodromal Questionnaire- Brief	The Prodromal Questionnaire- Brief (PQ-B) is a 21-item self-report survey assessing psychotic experiences such as common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled, mind reaching, etc.). and distress related to them. Each item is scored on a 0 to 5 scale. The total score is rated across the 21 items ranging between 0 and 105 with higher scores indicating more severe psychotic experiences.	Before the intervention, 6 weeks later, and 6 months later
Secondary	Connor-Davidson Resilience Scale	The Connor-Davidson Resilience Scale (CD-RISC) is a 25-item self-report scale obtaining ratings of one's level of coping and emotional resilience. It is rated on a scale of 0-100, with higher scores indicate one has more coping skills and more emotional resilience.	Before the intervention, 6 weeks later, and 6 months later