Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Not Applicable

Completed

• Conditions: MDD; Major Depressive Disorder; Depression
• Interventions: Device: Virtual Reality Behavioral Activation; Behavioral: Behavioral Activation in real-life

• Registration Number: NCT04268316
• Lead Sponsor: Stanford University

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 Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Start: 2020-05-18
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Results First Submitted: 2021-04-13
• Results First Submitted QC: 2021-04-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-08
• Results First Posted: 2021-05-10
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient must meet DSM V criteria for MDD
• Patient must be at least 18 years of age
• Patient must be English speaking

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Behavioral Activation	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 three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable activities to enjoy in virtual reality.
Behavioral Activation in real-life	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 three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life.

Primary Outcome Measures

Name	Time	Method
How Well Can Participants Tolerate the VR-BA Treatment?	Assessed at the end of week 3, after session 4	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).
Participant's Use of the VR Headset	Assessed at the end of week 3, after session 4	This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Participant's Desire to Continue Using VR After the Study Ends	Assessed at the end of week 3, after session 4	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).
How Present Did Individuals in the VR-BA Treatment Feel?	Assessed at the end of week 3, after session 4	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).
Number of Participants Who Dropped Out of Each Study Arm	3-weeks	Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Participant's Satisfaction With the VR-BA Treatment	Assessed at the end of week 3, after session 4	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).
Participant's Acceptance of VR-BA Treatment	Assessed at the end of week 3, after session 4	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).

Secondary Outcome Measures

Name	Time	Method
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms	Assessed at baseline and session 4.	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States