Major Depressive DisorderNCT04268316

Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

A study testing Virtual Reality Behavioral Activation and Behavioral Activation in real-life in people with Major Depressive Disorder and MDD, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder, MDD, Depression
What is being tested?: Virtual Reality Behavioral Activation and Behavioral Activation in real-life
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 May 2020to 15 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient must meet DSM V criteria for MDD
Patient must be at least 18 years of age
Patient must be English speaking

Who cannot join

Substance Use Disorders in past year
Any psychosis or bipolar I disorder
Any seizure in the last 6 months or untreated epilepsy
Current nonsuicidal self-injury or parasuicidal behavior
Current suicidal urges and intent

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Palo Alto, California, 94304

Other trials in United States

About this study

Read the detailed description

This is a treatment development trial. Participants will be randomly assigned to BA in VR, BA in real-life, or a waitlist control group. The former two groups will follow a BA protocol developed for primary care settings over a four-week treatment period. This study is taking place over Zoom, due to COVID-19.

Conditions: Major Depressive Disorder, MDD, Depression
Being tested: Virtual Reality Behavioral Activation, Behavioral Activation in real-life
Keywords: virtual reality, behavioral activation, depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Behavioral ActivationDevice
Participants will choose four "activities" to complete in virtual reality over the course of the week. These activities are video 360 and range from viewing animals, to viewing nature scenes, to traveling to a different location in the world, to viewing adrenaline-pumping activities.
Behavioral Activation in real-lifeBehavioural
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.

Study groups in NCT04268316
Study group	Role	What they receive
Virtual Reality Behavioral Activation	Experimental	Participants randomized to this arm will perform all of their behavioral activation in virtual reality. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality. Receives: Device: Virtual Reality Behavioral Activation
Behavioral Activation in real-life	Active comparator	Participants randomized to this arm will perform all of their behavioral activation in real life. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life. Receives: Behavioral: Behavioral Activation in real-life
Waitlist Control	No intervention	Participants randomized to this arm will not receive any type of intervention and will be asked to complete the PHQ-9 once a week for three weeks (4 sessions) to track symptoms. Participants will be offered to engage in behavioral activation in real life or with virtual reality when the four weeks are complete. Their data will only be used from the time they were on the waitlist.

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant's Desire to Continue Using VR After the Study Ends
This outcome was measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 3 questions, the total range was 0-12 (higher scores indicate greater acceptance).
Measured: Assessed at the end of week 3, after session 4
Number of Participants Who Dropped Out of Each Study Arm
Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Measured: 3-weeks
Participant's Satisfaction With the VR-BA Treatment
This outcome was measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 4 questions, the total range was 0-16 (higher scores indicate greater acceptance).
Measured: Assessed at the end of week 3, after session 4
Participant's Use of the VR Headset
This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Measured: Assessed at the end of week 3, after session 4
Participant's Acceptance of VR-BA Treatment
This was measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4), yielding a range of 0-52 (higher scores indicate greater acceptance).
Measured: Assessed at the end of week 3, after session 4
How Well Can Participants Tolerate the VR-BA Treatment?
This was determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual (0), Slightly more than usual (1), Moderately more than usual (2), or Severely more than usual (3), yielding a range of 0-48 (lower scores indicate greater tolerability).
Measured: Assessed at the end of week 3, after session 4
How Present Did Individuals in the VR-BA Treatment Feel?
This was measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all (0), Slightly (1), Moderately (2), Strongly (3), or Very Strongly (4), yielding a range of 0-12 (higher scores indicate greater presence).
Measured: Assessed at the end of week 3, after session 4

Secondary outcomes (1)

Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using VR-BA compared to BA in real life and a waitlist control. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 indicating the most severe depression and 0 indicating a lack of depression symptoms. The greater the change over time, the greater the symptom reduction.
Measured: Assessed at baseline and session 4.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202015 Jan 2021

First posted13 Feb 2020
Study start18 May 2020
Primary completion15 Jan 2021
Study completion15 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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
Model description: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04268316
Sponsor's protocol ID: 53483
Status last verified: May 2021
First submitted: 5 Feb 2020
Last updated: 2 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No current plan to share data.

Publications

Paul M, Bullock K, Bailenson J. Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: Case Report. JMIR Ment Health. 2020 Nov 3;7(11):e24331. doi: 10.2196/24331.
PubMed 33031046
Paul M, Bullock K, Bailenson J. Virtual Reality Behavioral Activation for Adults With Major Depressive Disorder: Feasibility Randomized Controlled Trial. JMIR Ment Health. 2022 May 6;9(5):e35526. doi: 10.2196/35526.
PubMed 35404830

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
ClinicalTrials.gov ID: NCT04268316
Acronym / sponsor ID: 53483
Conditions: Major Depressive Disorder, MDD, Depression
Keywords: virtual reality, behavioral activation, depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 18 May 2020 (actual)
Primary completion: 15 Jan 2021 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 13 Feb 2020 (actual)
Results: Posted 10 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.

Arm	Type	Receives
Virtual Reality Behavioral Activation	Experimental	Device: Virtual Reality Behavioral ActivationParticipants randomized to this arm will perform all of their behavioral activation in virtual reality. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality.
Behavioral Activation in real-life	Active comparator	Behavioral: Behavioral Activation in real-lifeParticipants randomized to this arm will perform all of their behavioral activation in real life. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life.
Waitlist Control	No intervention	–Participants randomized to this arm will not receive any type of intervention and will be asked to complete the PHQ-9 once a week for three weeks (4 sessions) to track symptoms. Participants will be offered to engage in behavioral activation in real life or with virtual reality when the four weeks are complete. Their data will only be used from the time they were on the waitlist.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient must meet DSM V criteria for MDD
Patient must be at least 18 years of age
Patient must be English speaking

Key exclusion criteria (5 listed)

Substance Use Disorders in past year
Any psychosis or bipolar I disorder
Any seizure in the last 6 months or untreated epilepsy
Current nonsuicidal self-injury or parasuicidal behavior
Current suicidal urges and intent

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
Virtual Reality Behavioral ActivationParticipants will choose four "activities" to complete in virtual reality over the course of the week. These activities are video 360 and range from viewing animals, to viewing nature scenes, to traveling to a different location in the world, to viewing adrenaline-pumping activities.	Device	Virtual Reality Behavioral Activation
Behavioral Activation in real-lifeParticipants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.	Behavioural	Behavioral Activation in real-life

Primary outcome

Participant's Desire to Continue Using VR After the Study Ends
Time frame: Assessed at the end of week 3, after session 4
This outcome was measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 3 questions, the total range was 0-12 (higher scores indicate greater acceptance).
Number of Participants Who Dropped Out of Each Study Arm
Time frame: 3-weeks
Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Participant's Satisfaction With the VR-BA Treatment
Time frame: Assessed at the end of week 3, after session 4
This outcome was measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 4 questions, the total range was 0-16 (higher scores indicate greater acceptance).
Participant's Use of the VR Headset
Time frame: Assessed at the end of week 3, after session 4
This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Participant's Acceptance of VR-BA Treatment
Time frame: Assessed at the end of week 3, after session 4
This was measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4), yielding a range of 0-52 (higher scores indicate greater acceptance).
How Well Can Participants Tolerate the VR-BA Treatment?
Time frame: Assessed at the end of week 3, after session 4
This was determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual (0), Slightly more than usual (1), Moderately more than usual (2), or Severely more than usual (3), yielding a range of 0-48 (lower scores indicate greater tolerability).
How Present Did Individuals in the VR-BA Treatment Feel?
Time frame: Assessed at the end of week 3, after session 4
This was measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all (0), Slightly (1), Moderately (2), Strongly (3), or Very Strongly (4), yielding a range of 0-12 (higher scores indicate greater presence).

1 secondary outcome

Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
Time frame: Assessed at baseline and session 4.

Results and safety

Results posted to the registry on 10 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Virtual Reality Behavioral Activation	5	3
Behavioral Activation in Real-life	4	3
Waitlist Control	4	4

Primary outcome: Participant's Desire to Continue Using VR After the Study Ends

Time frame: Assessed at the end of week 3, after session 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Virtual Reality Behavioral Activation n = 5
Value	9.54 (2.5)

Population analysed: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Primary outcome: Number of Participants Who Dropped Out of Each Study Arm

Time frame: 3-weeks. Count of participants. Unit: Participants

Measure	Virtual Reality Behavioral Activation n = 5	Behavioral Activation in Real-life n = 4	Waitlist Control n = 4
Value	2	1	0

Primary outcome: Participant's Satisfaction With the VR-BA Treatment

Time frame: Assessed at the end of week 3, after session 4. Mean (Standard Deviation). Unit: score on a scale

Measure	Virtual Reality Behavioral Activation n = 5
Value	12.5 (3.5)

Population analysed: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Primary outcome: Participant's Use of the VR Headset

Time frame: Assessed at the end of week 3, after session 4. Mean (Standard Deviation). Unit: times used

Measure	Virtual Reality Behavioral Activation n = 3
Value	21.7 (11)

Population analysed: This outcome measure was assessed in the Virtual Reality Behavioral Activation group of protocol completers only.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3-weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Virtual Reality Behavioral Activation	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Behavioral Activation in Real-life	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Waitlist Control	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): This study did not enroll to its planned sample size of 30.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33031046Paul M, Bullock K, Bailenson J. Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: Case Report. JMIR Ment Health. 2020 Nov 3;7(11):e24331. doi: 10.2196/24331.
Derived from this study: PubMed 35404830Paul M, Bullock K, Bailenson J. Virtual Reality Behavioral Activation for Adults With Major Depressive Disorder: Feasibility Randomized Controlled Trial. JMIR Ment Health. 2022 May 6;9(5):e35526. doi: 10.2196/35526.
Individual participant dataSharing planned: No. No current plan to share data.

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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.

Kim Bullock, MD study director

Stanford University

Margot Paul, MS principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Behavioral Activation and Behavioral Activation in real-life in people with Major Depressive Disorder and MDD, run by Stanford University 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 3 inclusion and 5 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 2 Jun 2021. 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?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participant's Desire to Continue Using VR After the Study Ends (time frame: Assessed at the end of week 3, after session 4). The study lists 7 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 NCT04268316, which also lists 2 linked publications.

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 2 Jun 2021.