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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

Tracking Information
First Submitted Date  ICMJE February 5, 2020
First Posted Date  ICMJE February 13, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE May 18, 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
  • 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.
  • Rates of dropout of VR-BA [ Time Frame: 4-weeks ]
    Participant treatment dropout will be compared across each study arm.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2020)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Official Title  ICMJE Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Major Depressive Disorder
  • MDD
  • Depression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Virtual Reality Behavioral Activation
  • 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.
    Intervention: Behavioral: Behavioral Activation 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2020)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margot D Paul, MS 4156253127 mdpaul@stanford.edu
Contact: Kim Bullock, MD 6507141459 kbullock@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04268316
Other Study ID Numbers  ICMJE 53483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No current plan to share data.
Responsible Party Kim Bullock, MD, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim Bullock, MD Stanford University
Study Director: Margot Paul, MS Stanford University
PRS Account Stanford University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP