Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Depression Clinical Trial

Official title:

Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268316
• Other study ID #: 53483
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Assessed at the end of week 3, after session 4
Primary	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.	3-weeks
Primary	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).	Assessed at the end of week 3, after session 4
Primary	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.	Assessed at the end of week 3, after session 4
Primary	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).	Assessed at the end of week 3, after session 4
Primary	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).	Assessed at the end of week 3, after session 4
Primary	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).	Assessed at the end of week 3, after session 4
Secondary	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.	Assessed at baseline and session 4.