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Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268316
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kim Bullock, MD, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder MDD Depression Device: Virtual Reality Behavioral Activation Behavioral: Behavioral Activation in real-life Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual Reality Behavioral Activation
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 four weeks. In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality.
 Device: Virtual Reality Behavioral Activation
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.
Active Comparator: Behavioral Activation in real-life
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 four weeks. In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life.
 Behavioral: Behavioral Activation in real-life
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
No Intervention: Waitlist Control
Participants randomized to this arm will not receive any type of intervention and will be asked to complete the PHQ-9 once a week 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.


Outcome Measures
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Primary Outcome Measures :
  1. Participant's desire to continue using VR after the study ends [ Time Frame: 4-weeks ]
    This outcome will be 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, Disagree, Neutral, Agree, or Strongly Agree.

  2. Rates of dropout of VR-BA [ Time Frame: 4-weeks ]
    Participant treatment dropout will be compared across each study arm.

  3. Participant's satisfaction with the VR-BA treatment [ Time Frame: 4-weeks ]
    This outcome will be 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, Disagree, Neutral, Agree, or Strongly Agree.

  4. Participant's use of the VR headset [ Time Frame: 4-weeks ]
    This will be measured by noting the amount of times the VR headset is used.

  5. Participant's acceptance of VR-BA treatment [ Time Frame: 4-weeks ]
    This will be measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.

  6. How well can participants tolerate the VR-BA treatment? [ Time Frame: 4-weeks ]
    This will be determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual, Slightly more than usual, Moderately more than usual, or Severely more than usual.

  7. How present did individuals in the VR-BA treatment feel? [ Time Frame: 4-weeks. ]
    This will be measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all, Slightly, Moderately, Strongly, or Very Strongly.


Secondary Outcome Measures :
  1. Clinical efficacy of using VR as a tool to deliver BA [ Time Frame: 4-weeks ]
    How participants' depression scores 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268316


Contacts
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Contact: Margot D Paul, MS 4156253127 mdpaul@stanford.edu
Contact: Kim Bullock, MD 6507141459 kbullock@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Margot Paul, M.S.    415-625-3127    mdpaul@stanford.edu   
Contact: Kim Bullock, MD    6507141459    kbullock@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kim Bullock, MD Stanford University
Study Director: Margot Paul, MS Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kim Bullock, MD, Diplomat, Neuropsychiatry & Behavioral Neurology, UCNS Diplomate of the American Board of Lifestyle Medicine Director, Virtual Reality-Immersive Technology (VR-IT) Clinic & Laboratory, Stanford University
ClinicalTrials.gov Identifier: NCT04268316    
Other Study ID Numbers: 53483
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

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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.: Yes
Keywords provided by Kim Bullock, MD, Stanford University:
virtual reality
behavioral activation
depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders