Mood DisordersNCT06360562
Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)
A study testing Resilience Training in people with Mood Disorders and Anxiety Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- What is being tested?
- Resilience Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18-30 years old
- Enrolled in an undergraduate program
- At least 18 years old
- Employed in the healthcare field with some direct patient contact
Who cannot join
- Inability to provide informed consent
- Not proficient in English
- 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.
- Enrolled in current psychotherapy with frequency of more than once per month
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)- Resilience Training in Virtual Reality
This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality.
- Conditions
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- Being tested
- Resilience Training
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience TrainingBehavioural
Behavioral group-based intervention delivering mindfulness, metallization, and self-compassion skills.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Training | Experimental | A 6 1-hour session group based intervention to deliver mindfulness, metallization, and self-compassion. Receives: Behavioral: Resilience Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
Intervention Feasibility and Acceptability
This measure includes participant attendance, with more attendance of the intervention indicating better feasibility and acceptability.
Measured: Before the intervention, 6 weeks later, and 6 months later
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
Secondary outcomes (4)
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
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.
Measured: Before the intervention, 6 weeks later, and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Sep 2020
- Primary completion30 Jan 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Holt, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360562
- Sponsor's protocol ID
- 2020P002418
- Status last verified
- May 2026
- First submitted
- 29 Aug 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with investigator permission.
Publications
Holt DJ, DeTore NR, Aideyan B, Utter L, Vinke L, Johnson DS, Zimmerman J, Dokholyan KN, Burke A. Enhancing social functioning using multi-user, immersive virtual reality. Sci Rep. 2025 Jan 22;15(1):2790. doi: 10.1038/s41598-024-84954-4.
PubMed 39843493
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)- Resilience Training in Virtual Reality
- ClinicalTrials.gov ID
- NCT06360562
- Acronym / sponsor ID
- 2020P002418
- Conditions
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Apr 2024 (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.
This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resilience Training | Experimental | Behavioral: Resilience TrainingA 6 1-hour session group based intervention to deliver mindfulness, metallization, and self-compassion. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 18-30 years old
- Enrolled in an undergraduate program
- At least 18 years old
- Employed in the healthcare field with some direct patient contact
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Not proficient in English
- 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.
- Enrolled in current psychotherapy with frequency of more than once per month
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 |
|---|---|---|
| Resilience TrainingBehavioral group-based intervention delivering mindfulness, metallization, and self-compassion skills. | Behavioural | Resilience Training |
Primary outcome
Discomfort with Others
Time frame: Before the intervention, 6 weeks later, and 6 months later
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.
Intervention Feasibility and Acceptability
Time frame: Before the intervention, 6 weeks later, and 6 months later
This measure includes participant attendance, with more attendance of the intervention indicating better feasibility and acceptability.
Penn Emotion Recognition Test
Time frame: Before the intervention, 6 weeks later, and 6 months later
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.
Stop Distance Paradigm
Time frame: Before the intervention, 6 weeks later, and 6 months later
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.
4 secondary outcomes
Beck Depression Inventory
Time frame: Before the intervention, 6 weeks later, and 6 months later
Spielberger State-Trait Anxiety Inventory
Time frame: Before the intervention, 6 weeks later, and 6 months later
Prodromal Questionnaire- Brief
Time frame: Before the intervention, 6 weeks later, and 6 months later
Connor-Davidson Resilience Scale
Time frame: Before the intervention, 6 weeks later, and 6 months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 39843493Holt DJ, DeTore NR, Aideyan B, Utter L, Vinke L, Johnson DS, Zimmerman J, Dokholyan KN, Burke A. Enhancing social functioning using multi-user, immersive virtual reality. Sci Rep. 2025 Jan 22;15(1):2790. doi: 10.1038/s41598-024-84954-4.
- Individual participant dataSharing planned: No. Data will be shared with investigator permission.
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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 Resilience Training in people with Mood Disorders and Anxiety Disorders, run by Massachusetts General Hospital at 1 site in United States.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Discomfort with Others (time frame: Before the intervention, 6 weeks later, and 6 months later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360562, which also lists 1 linked publication.
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 11 May 2026.