Back to resultsVirtual 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
Virtual Reality Behavioral Activation
Behavioral Activation in real-life
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring 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 I disorder
- Any seizure in the last 6 months or untreated epilepsy
- Current nonsuicidal self-injury or parasuicidal behavior
- Current suicidal urges and intent
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Virtual Reality Behavioral Activation
Behavioral Activation in real-life
Waitlist Control
Arm Description
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.
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 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.
Outcomes
Primary Outcome Measures
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).
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 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).
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.
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).
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).
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04268316
Brief Title
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Official Title
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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
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 either BA in VR, BA in real-life, or a waitlist control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Behavioral Activation
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral Activation in real-life
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Behavioral Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation in real-life
Intervention Description
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
Primary Outcome Measure Information:
Title
Participant's Desire to Continue Using VR 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 at the end of week 3, after session 4
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 VR-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 at the end of week 3, after session 4
Title
Participant's Use of the VR Headset
Description
This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Time Frame
Assessed at the end of week 3, after session 4
Title
Participant's Acceptance of VR-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 at the end of week 3, after session 4
Title
How Well Can Participants Tolerate the VR-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 at the end of week 3, after session 4
Title
How Present Did Individuals in the VR-BA Treatment Feel?
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 at the end of week 3, after session 4
Secondary Outcome Measure Information:
Title
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
Description
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.
Time Frame
Assessed at baseline and session 4.
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 I disorder
Any seizure in the last 6 months or untreated epilepsy
Current nonsuicidal self-injury or parasuicidal behavior
Current suicidal urges and intent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Bullock, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Margot Paul, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
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.
Citations:
PubMed Identifier
33031046
Citation
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.
Results Reference
result
PubMed Identifier
35404830
Citation
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.
Results Reference
derived
Learn more about this trial
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
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