Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

September 16, 2025 updated by: Margot Paul, PsyD, Stanford University
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). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Behavioral Activation
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.
Behavioral: Traditional Behavioral Activation
Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.
Experimental: XR-Enhanced Behavioral Activation
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.
Behavioral: Extended Reality-Enhanced Behavioral Activation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-weeks
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.
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).
Assessed after session 4, at the end of week 3.
Participant's Satisfaction With the XR-Enhanced BA Treatment
Time Frame: Assessed after session 4, at the end of week 3.
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).
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.
This was measured by noting the amount of times the XR headset is used during the 3-week study period.
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.
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).
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.
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).
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.
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).
Assessed after session 4, at the end of week 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Margot D Paul, Psy.D., Stanford University
  • Study Chair: Kim Bullock, M.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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