Clinical trial NCT04268316: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
MDD
Depression
Keywords: virtual reality
behavioral activation
depression
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant's Desire to Continue Using VR After the Study Ends
timeFrame: Assessed at the end of week 3, after session 4
measure: Number of Participants Who Dropped Out of Each Study Arm
timeFrame: 3-weeks
measure: Participant's Satisfaction With the VR-BA Treatment
timeFrame: Assessed at the end of week 3, after session 4
measure: Participant's Use of the VR Headset
timeFrame: Assessed at the end of week 3, after session 4
measure: Participant's Acceptance of VR-BA Treatment
timeFrame: Assessed at the end of week 3, after session 4
measure: How Well Can Participants Tolerate the VR-BA Treatment?
timeFrame: Assessed at the end of week 3, after session 4
measure: How Present Did Individuals in the VR-BA Treatment Feel?
timeFrame: Assessed at the end of week 3, after session 4
Secondary outcomes:
measure: Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
timeFrame: Assessed at baseline and session 4.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kim Bullock, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Margot Paul, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.