Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04268316
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Actual Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; MDD; Depression	Device: Virtual Reality Behavioral Activation; Behavioral: Behavioral Activation in real-life	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
• Actual Study Start Date: May 18, 2020
• Actual Primary Completion Date: Jan 15, 2021
• Actual Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.
No Intervention: Waitlist Control 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.

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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.

3. 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).

4. 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.

5. 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).

6. 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).

7. 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).

Secondary Outcome Measures

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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Study Director: Kim Bullock, MD, Stanford University
• Principal Investigator: Margot Paul, MS, Stanford University

Study Documents (Full-Text)

• Study Protocol - Feb 25, 2020
• Statistical Analysis Plan - Apr 13, 2021

More Information

Publications

None provided.

• Responsible Party: Margot Paul, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT04268316
• Other Study ID Numbers: 53483
• First Posted: Feb 13, 2020
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Margot Paul, Principle Investigator, Stanford University: virtual reality; behavioral activation; depression
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

Participant Flow

Pre-assignment Detail	20 participants signed consent, but only 13 participants were randomized to a study arm.

Arm/Group Title	Virtual Reality Behavioral Activation	Behavioral Activation in Real-life	Waitlist Control
Arm/Group Description	Participants engage in VR activities over the week for three weeks.	Participants engage in real life pleasurable activities over the week for three weeks.	Participants answer the PHQ-9 weekly for four sessions.
Period Title: Overall Study
STARTED	5	4	4
COMPLETED	3	3	4
NOT COMPLETED	2	1	0

Baseline Characteristics

Arm/Group Title	Virtual Reality Behavioral Activation	Behavioral Activation in Real-life	Waitlist Control	Total
Arm/Group Description	Participants engage in VR activities over the week for three weeks.	Participants engage in real life pleasurable activities over the week for three weeks.	Participants answer the PHQ-9 weekly for four sessions.	Total of all reporting groups
Overall Participants	5	4	4	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (9.2)	46 (15.7)	29.5 (5.2)	35.4 (12.3)
Sex/Gender, Customized (Count of Participants)
male	1 20%	3 75%	1 25%	5 38.5%
female	4 80%	1 25%	2 50%	7 53.8%
non-binary/third gender	0 0%	0 0%	1 25%	1 7.7%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic Caucasian	3 60%	3 75%	1 25%	7 53.8%
Chinese	1 20%	1 25%	0 0%	2 15.4%
Indian	1 20%	0 0%	0 0%	1 7.7%
African American	0 0%	0 0%	1 25%	1 7.7%
Mexican	0 0%	0 0%	1 25%	1 7.7%
Hispanic/Latino	0 0%	0 0%	1 25%	1 7.7%
Region of Enrollment (Count of Participants)
United States	5 100%	4 100%	4 100%	13 100%
Patient Health Questionnaire-9 (PHQ-9) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	14.3 (5.7)	15.3 (4.9)	14 (4.1)	14.5 (4.3)

Outcome Measures

1. Primary Outcome

Title	Participant's Desire to Continue Using VR After the Study Ends
Description	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).
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	5
Mean (Standard Deviation) [score on a scale]	9.54 (2.5)

2. Primary Outcome

Title	Number of Participants Who Dropped Out of Each Study Arm
Description	Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Time Frame	3-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Reality Behavioral Activation	Behavioral Activation in Real-life	Waitlist Control
Arm/Group Description	Participants engage in VR activities over the week for three weeks.	Participants engage in real life pleasurable activities over the week for three weeks.	Participants answer the PHQ-9 weekly for four sessions.
Measure Participants	5	4	4
Count of Participants [Participants]	2 40%	1 25%	0 0%

3. Primary Outcome

Title	Participant's Satisfaction With the VR-BA Treatment
Description	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).
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	5
Mean (Standard Deviation) [score on a scale]	12.5 (3.5)

4. Primary Outcome

Title	Participant's Use of the VR Headset
Description	This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group of protocol completers only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	3
Mean (Standard Deviation) [times used]	21.7 (11)

5. Primary Outcome

Title	Participant's Acceptance of VR-BA Treatment
Description	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).
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	5
Mean (Standard Deviation) [score on a scale]	42.4 (8.4)

6. Primary Outcome

Title	How Well Can Participants Tolerate the VR-BA Treatment?
Description	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).
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	5
Mean (Full Range) [score on a scale]	2.9

7. Primary Outcome

Title	How Present Did Individuals in the VR-BA Treatment Feel?
Description	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).
Time Frame	Assessed at the end of week 3, after session 4

Outcome Measure Data

Analysis Population Description

This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.

Arm/Group Title	Virtual Reality Behavioral Activation
Arm/Group Description	Participants engage in VR activities over the week for three weeks.
Measure Participants	5
Mean (Standard Deviation) [score on a scale]	7.1 (2.8)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Protocol Completers

Arm/Group Title	Virtual Reality Behavioral Activation	Behavioral Activation in Real-life	Waitlist Control
Arm/Group Description	Participants engage in VR activities over the week for three weeks.	Participants engage in real life pleasurable activities over the week for three weeks.	Participants answer the PHQ-9 weekly for four sessions.
Measure Participants	3	3	4
Mean (Full Range) [score on a scale]	5.7	3	.25

Adverse Events

Time Frame	3-weeks
Arm/Group Title	Virtual Reality Behavioral Activation		Behavioral Activation in Real-life		Waitlist Control
Arm/Group Description	Participants engage in VR activities over the week for three weeks.		Participants engage in real life pleasurable activities over the week for three weeks.		Participants answer the PHQ-9 weekly for four sessions.
All Cause Mortality
	Virtual Reality Behavioral Activation		Behavioral Activation in Real-life		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/4 (0%)
Serious Adverse Events
	Virtual Reality Behavioral Activation		Behavioral Activation in Real-life		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Virtual Reality Behavioral Activation		Behavioral Activation in Real-life		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/4 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.