Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Stanford University

Status: Completed

Conditions: Major Depressive Disorder; Depression; MDD

Treatments: Behavioral: Behavioral Activation in real-life; Device: Virtual Reality Behavioral Activation

Study type: Interventional

Funder types: Other

Identifiers

NCT04268316

53483

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Virtual Reality Behavioral Activation

Experimental group

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.

Treatment:

Device: Virtual Reality Behavioral Activation

Behavioral Activation in real-life

Active Comparator group

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.

Treatment:

Behavioral: Behavioral Activation in real-life

Waitlist Control

No Intervention group

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.