Major Depressive DisorderNCT05525390

Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

A study testing Extended Reality-Enhanced Behavioral Activation and Traditional Behavioral Activation 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 aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). 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?: Extended Reality-Enhanced Behavioral Activation and Traditional Behavioral Activation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2022to 24 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

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 disorder
Any seizure in the last 6 months or untreated epilepsy
Current nonsuicidal self-injury or parasuicidal behavior
Current suicidal urges and intent
Changing psychotherapy treatment within four months of study entry
Changing psychotropic medication(s) within two months of study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Read the detailed description

This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.

Conditions: Major Depressive Disorder, MDD, Depression
Being tested: Extended Reality-Enhanced Behavioral Activation, Traditional Behavioral Activation
Keywords: Extended Reality, 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.

Extended Reality-Enhanced Behavioral ActivationBehavioural
Participants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.
Traditional Behavioral ActivationBehavioural
Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.

Study groups in NCT05525390
Study group	Role	What they receive
Traditional Behavioral Activation	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. Participants will complete the PHQ-9 and their activity monitoring and scheduling on separate worksheets. Receives: Behavioral: Traditional Behavioral Activation
XR-Enhanced Behavioral Activation	Experimental	Participants randomized to this arm will perform all of their behavioral activation in extended reality (XR). Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick at least four pleasurable activities to enjoy in extended reality. Participants will complete their post-XR surveys and add and schedule activities on separate worksheets. Receives: Behavioral: Extended Reality-Enhanced Behavioral Activation

What is being measured

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

Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. 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 beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).

Secondary outcomes (7)

Participant's Desire to Continue Using Extended Reality (XR) 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 after session 4, at the end of week 3.
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 XR-Enhanced 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 after session 4, at the end of week 3.
Participant's Use of the XR Headset
This was measured by noting the amount of times the XR headset is used during the 3-week study period.
Measured: Assessed after session 4, at the end of week 3.
Participant's Acceptance of XR-Enhanced 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 after session 4, at the end of week 3.
How Well Can Participants Tolerate the XR-Enhanced 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 after session 4, at the end of week 3.
How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?
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 after session 4, at the end of week 3.

Timeline

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

19 Dec 202224 Jul 2023

First posted1 Sep 2022
Study start19 Dec 2022
Primary completion24 Jul 2023
Study completion24 Jul 2023

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 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 receive either XR-enhanced behavioral activation or traditional behavioral activation.
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05525390
Sponsor's protocol ID: 66488
Status last verified: Sep 2025
First submitted: 30 Aug 2022
Last updated: 22 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No current plan to share data.

Publications

Paul M, Bullock K, Bailenson J, Burns D. Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial. JMIR Ment Health. 2024 Apr 15;11:e52326. doi: 10.2196/52326.
PubMed 38437873

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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
ClinicalTrials.gov ID: NCT05525390
Acronym / sponsor ID: 66488
Conditions: Major Depressive Disorder, MDD, Depression
Keywords: Extended Reality, Virtual Reality, Behavioral Activation, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 19 Dec 2022 (actual)
Primary completion: 24 Jul 2023 (actual)
Study completion: 24 Jul 2023 (actual)
First posted: 1 Sep 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.

Arm	Type	Receives
Traditional Behavioral Activation	Active comparator	Behavioral: Traditional Behavioral ActivationParticipants 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. Participants will complete the PHQ-9 and their activity monitoring and scheduling on separate worksheets.
XR-Enhanced Behavioral Activation	Experimental	Behavioral: Extended Reality-Enhanced Behavioral ActivationParticipants randomized to this arm will perform all of their behavioral activation in extended reality (XR). Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick at least four pleasurable activities to enjoy in extended reality. Participants will complete their post-XR surveys and add and schedule activities on separate worksheets.

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 (7 listed)

Substance Use Disorders in past year
Any psychosis or bipolar 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
Extended Reality-Enhanced Behavioral ActivationParticipants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.	Behavioural	XR-Enhanced Behavioral Activation
Traditional Behavioral ActivationParticipants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.	Behavioural	Traditional Behavioral Activation

Primary outcome

Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
Time frame: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. 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.

7 secondary outcomes

Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends
Time frame: Assessed after session 4, at the end of week 3.
Number of Participants Who Dropped Out of Each Study Arm
Time frame: 3-weeks
Participant's Satisfaction With the XR-Enhanced BA Treatment
Time frame: Assessed after session 4, at the end of week 3.
Participant's Use of the XR Headset
Time frame: Assessed after session 4, at the end of week 3.
Participant's Acceptance of XR-Enhanced BA Treatment
Time frame: Assessed after session 4, at the end of week 3.
How Well Can Participants Tolerate the XR-Enhanced BA Treatment?
Time frame: Assessed after session 4, at the end of week 3.
How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?
Time frame: Assessed after session 4, at the end of week 3.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Results publication: PubMed 38437873Paul M, Bullock K, Bailenson J, Burns D. Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial. JMIR Ment Health. 2024 Apr 15;11:e52326. doi: 10.2196/52326.
Related InfoLink provided by the sponsor.
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.

Margot D Paul, Psy.D. principal investigator

Stanford University

Kim Bullock, M.D. study chair

Stanford University

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

Questions about this trial

What is this clinical trial studying?

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 7 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 22 Sep 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms (time frame: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).). 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 NCT05525390, 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 22 Sep 2025.