Trial Outcomes & Findings for Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder (NCT NCT04268316)
NCT ID: NCT04268316
Last Updated: 2021-06-02
Results Overview
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).
COMPLETED
NA
20 participants
Assessed at the end of week 3, after session 4
2021-06-02
Participant Flow
20 participants signed consent, but only 13 participants were randomized to a study arm.
Participant milestones
| Measure |
Virtual Reality Behavioral Activation
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Virtual Reality Behavioral Activation
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
Participants that completed the protocol are included in the analysis.
Baseline characteristics by cohort
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
n=4 Participants
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
n=4 Participants
Participants answer the PHQ-9 weekly for four sessions.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
46 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
29.5 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
35.4 years
STANDARD_DEVIATION 12.3 • n=13 Participants
|
|
Sex/Gender, Customized
male
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=13 Participants
|
|
Sex/Gender, Customized
female
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=13 Participants
|
|
Sex/Gender, Customized
non-binary/third gender
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Caucasian
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=13 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
14.3 score on a scale
STANDARD_DEVIATION 5.7 • n=3 Participants • Participants that completed the protocol are included in the analysis.
|
15.3 score on a scale
STANDARD_DEVIATION 4.9 • n=3 Participants • Participants that completed the protocol are included in the analysis.
|
14 score on a scale
STANDARD_DEVIATION 4.1 • n=4 Participants • Participants that completed the protocol are included in the analysis.
|
14.5 score on a scale
STANDARD_DEVIATION 4.3 • n=10 Participants • Participants that completed the protocol are included in the analysis.
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
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).
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Participant's Desire to Continue Using VR After the Study Ends
|
9.54 score on a scale
Standard Deviation 2.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 3-weeksParticipant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
n=4 Participants
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
n=4 Participants
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Number of Participants Who Dropped Out of Each Study Arm
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
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).
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Participant's Satisfaction With the VR-BA Treatment
|
12.5 score on a scale
Standard Deviation 3.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group of protocol completers only.
This was measured by noting the amount of times the VR headset is used during the 3-week study period.
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=3 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Participant's Use of the VR Headset
|
21.7 times used
Standard Deviation 11
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
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).
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Participant's Acceptance of VR-BA Treatment
|
42.4 score on a scale
Standard Deviation 8.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
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).
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
How Well Can Participants Tolerate the VR-BA Treatment?
|
2.9 score on a scale
Interval 0.4 to 8.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at the end of week 3, after session 4Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
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).
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=5 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
How Present Did Individuals in the VR-BA Treatment Feel?
|
7.1 score on a scale
Standard Deviation 2.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline and session 4.Population: Protocol Completers
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.
Outcome measures
| Measure |
Virtual Reality Behavioral Activation
n=3 Participants
Participants engage in VR activities over the week for three weeks.
|
Behavioral Activation in Real-life
n=3 Participants
Participants engage in real life pleasurable activities over the week for three weeks.
|
Waitlist Control
n=4 Participants
Participants answer the PHQ-9 weekly for four sessions.
|
|---|---|---|---|
|
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
|
5.7 score on a scale
Interval 2.0 to 12.0
|
3 score on a scale
Interval 2.0 to 5.0
|
.25 score on a scale
Interval -5.0 to 3.0
|
Adverse Events
Virtual Reality Behavioral Activation
Behavioral Activation in Real-life
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place