Back to resultsExtended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Primary Purpose
Major Depressive Disorder, MDD, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extended Reality-Enhanced Behavioral Activation
Traditional Behavioral Activation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Extended Reality, Virtual Reality, Behavioral Activation, Depression
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Behavioral Activation
XR-Enhanced Behavioral Activation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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).
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.
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05525390
Brief Title
Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Official Title
Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
July 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, MDD, Depression
Keywords
Extended Reality, Virtual Reality, Behavioral Activation, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Behavioral Activation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
XR-Enhanced Behavioral Activation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Extended Reality-Enhanced Behavioral Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Behavioral Activation
Intervention Description
Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.
Primary Outcome Measure Information:
Title
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
Description
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.
Time Frame
Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
Secondary Outcome Measure Information:
Title
Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends
Description
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).
Time Frame
Assessed after session 4, at the end of week 3.
Title
Number of Participants Who Dropped Out of Each Study Arm
Description
Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Time Frame
3-weeks
Title
Participant's Satisfaction With the XR-Enhanced BA Treatment
Description
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).
Time Frame
Assessed after session 4, at the end of week 3.
Title
Participant's Use of the XR Headset
Description
This was measured by noting the amount of times the XR headset is used during the 3-week study period.
Time Frame
Assessed after session 4, at the end of week 3.
Title
Participant's Acceptance of XR-Enhanced BA Treatment
Description
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).
Time Frame
Assessed after session 4, at the end of week 3.
Title
How Well Can Participants Tolerate the XR-Enhanced BA Treatment?
Description
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).
Time Frame
Assessed after session 4, at the end of week 3.
Title
How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?
Description
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).
Time Frame
Assessed after session 4, at the end of week 3.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margot D Paul, Psy.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Bullock, M.D.
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to share data.
Learn more about this trial
Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
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