Depression, Major Depressive Disorder, MDD
Conditions
Keywords
virtual reality, behavioral activation, depression
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.
Interventions
BEHAVIORALBehavioral Activation in real-life
Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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 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 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
20 participants signed consent, but only 13 participants were randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality Behavioral Activation Participants engage in VR activities over the week for three weeks. | 5 |
| Behavioral Activation in Real-life Participants engage in real life pleasurable activities over the week for three weeks. | 4 |
| Waitlist Control Participants answer the PHQ-9 weekly for four sessions. | 4 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Virtual Reality Behavioral Activation | Behavioral Activation in Real-life | Waitlist Control | Total |
|---|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 9.2 | 46 years STANDARD_DEVIATION 15.7 | 29.5 years STANDARD_DEVIATION 5.2 | 35.4 years STANDARD_DEVIATION 12.3 |
| Patient Health Questionnaire-9 (PHQ-9) | 14.3 score on a scale STANDARD_DEVIATION 5.7 | 15.3 score on a scale STANDARD_DEVIATION 4.9 | 14 score on a scale STANDARD_DEVIATION 4.1 | 14.5 score on a scale STANDARD_DEVIATION 4.3 |
| Race/Ethnicity, Customized African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Chinese | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mexican | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Caucasian | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Region of Enrollment United States | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Sex/Gender, Customized female | 4 Participants | 1 Participants | 2 Participants | 7 Participants |
| Sex/Gender, Customized male | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Sex/Gender, Customized non-binary/third gender | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 |
Outcome results
Primary
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).
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Behavioral Activation | How Present Did Individuals in the VR-BA Treatment Feel? | 7.1 score on a scale | Standard Deviation 2.8 |
Primary
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).
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality Behavioral Activation | How Well Can Participants Tolerate the VR-BA Treatment? | 2.9 score on a scale |
Primary
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.
Time frame: 3-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual Reality Behavioral Activation | Number of Participants Who Dropped Out of Each Study Arm | 2 Participants |
| Behavioral Activation in Real-life | Number of Participants Who Dropped Out of Each Study Arm | 1 Participants |
| Waitlist Control | Number of Participants Who Dropped Out of Each Study Arm | 0 Participants |
Primary
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).
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Behavioral Activation | Participant's Acceptance of VR-BA Treatment | 42.4 score on a scale | Standard Deviation 8.4 |
Primary
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).
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Behavioral Activation | Participant's Desire to Continue Using VR After the Study Ends | 9.54 score on a scale | Standard Deviation 2.5 |
Primary
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).
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Behavioral Activation | Participant's Satisfaction With the VR-BA Treatment | 12.5 score on a scale | Standard Deviation 3.5 |
Primary
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.
Time frame: Assessed at the end of week 3, after session 4
Population: This outcome measure was assessed in the Virtual Reality Behavioral Activation group of protocol completers only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Behavioral Activation | Participant's Use of the VR Headset | 21.7 times used | Standard Deviation 11 |
Secondary
Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms
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.
Population: Protocol Completers
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Reality Behavioral Activation | Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms | 5.7 score on a scale |
| Behavioral Activation in Real-life | Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms | 3 score on a scale |
| Waitlist Control | Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms | .25 score on a scale |