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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Bullock, MD | Stanford University | Study Director |
| Margot Paul, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33031046 | Result | 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. | |
| 35404830 | Derived | 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. |
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No current plan to share data.
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20 participants signed consent, but only 13 participants were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Behavioral Activation | Participants engage in VR activities over the week for three weeks. |
| FG001 | Behavioral Activation in Real-life | Participants engage in real life pleasurable activities over the week for three weeks. |
| FG002 | Waitlist Control | Participants answer the PHQ-9 weekly for four sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Behavioral Activation | Participants engage in VR activities over the week for three weeks. |
| BG001 | Behavioral Activation in Real-life | Participants engage in real life pleasurable activities over the week for three weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | This outcome measure was assessed in the Virtual Reality Behavioral Activation group only. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of week 3, after session 4 |
|
3-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Behavioral Activation | Participants engage in VR activities over the week for three weeks. |
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This study did not enroll to its planned sample size of 30.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Paul | Stanford University | 415-625-3127 | mdpaul@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2020 | Apr 13, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2021 | Apr 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Participants will be randomized to either BA in VR, BA in real-life, or a waitlist control group.
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| 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. |
|
| 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 |
| Assessed at baseline and session 4. |
| BG002 | Waitlist Control | Participants answer the PHQ-9 weekly for four sessions. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Patient Health Questionnaire-9 (PHQ-9) | Total Score Depression Severity
| Participants that completed the protocol are included in the analysis. | Mean | Standard Deviation | score on a scale |
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| Units | Counts |
|---|---|
| Participants |
|
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| 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. | Posted | Count of Participants | Participants | 3-weeks |
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| 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). | This outcome measure was assessed in the Virtual Reality Behavioral Activation group only. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of week 3, after session 4 |
|
|
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| 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. | This outcome measure was assessed in the Virtual Reality Behavioral Activation group of protocol completers only. | Posted | Mean | Standard Deviation | times used | Assessed at the end of week 3, after session 4 |
|
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| 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). | This outcome measure was assessed in the Virtual Reality Behavioral Activation group only. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of week 3, after session 4 |
|
|
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| 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). | This outcome measure was assessed in the Virtual Reality Behavioral Activation group only. | Posted | Mean | Full Range | score on a scale | Assessed at the end of week 3, after session 4 |
|
|
|
| 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). | This outcome measure was assessed in the Virtual Reality Behavioral Activation group only. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of week 3, after session 4 |
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| 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. | Protocol Completers | Posted | Mean | Full Range | score on a scale | Assessed at baseline and session 4. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Behavioral Activation in Real-life | Participants engage in real life pleasurable activities over the week for three weeks. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Waitlist Control | Participants answer the PHQ-9 weekly for four sessions. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001519 |
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