Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

NCT04268316 | Completed Results DMC FDA Device

• 1 other identifier: 53483
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; MDD; Depression

Keywords

virtual reality; behavioral activation; depression

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms

  Assessed at baseline and session 4.

Study Arms (3)

Virtual Reality Behavioral Activation

EXPERIMENTAL

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.

Device: Virtual Reality Behavioral Activation

Behavioral Activation in real-life

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Activation in real-life

Waitlist Control

NO INTERVENTION

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.

Interventions

Virtual Reality Behavioral Activation DEVICE

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.

Virtual Reality Behavioral Activation

Behavioral Activation in real-life BEHAVIORAL

Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.

Behavioral Activation in real-life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 33031046 RESULT

• 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.

  PMID: 35404830 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

This study did not enroll to its planned sample size of 30.

Results Point of Contact

• Title: Margot Paul
• Organization: Stanford University

mdpaul@stanford.edu

415-625-3127

Study Officials

• Kim Bullock, MD

  Stanford University

  STUDY DIRECTOR

• Margot Paul, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: May 18, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: June 2, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)