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The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive virtual reality (VR) headset to engage in behavioral activation (BA) for older adults diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using VR to enhance BA therapy in a clinical MDD older adult population.
This research study is looking for older adults with depression to participate in a research study on the use of virtual reality (VR)-enhanced behavioral activation therapy for depression. The purpose of the study is to learn more about using VR to enhance behavioral activation as a treatment for MDD.
Behavioral activation is defined as identifying pleasant and/or mastery activities, scheduling them into your calendar, and completing the identified activities during the week. The identification of pleasant and mastery activities will begin in session with a therapist and will include tracking the participant's hourly activities with the activity/ mood monitoring form and identifying how much pleasure and/or mastery the participant may feel when completing these activities. The following session, the participant and therapist will be able to identify patterns and discuss how to decrease unhelpful behaviors and explore the participant's interests and values to increase positive behaviors. The clinician will explain how to use the loaned VR headset, which looks similar to glasses. The participant will be asked to choose VR activities of interest to complete in between sessions and schedule them into their activity scheduling sheet. They will be asked to rate their mood before and after engaging with the VR headset. A discussion of barriers to completion and problem-solving will also be discussed in session. Once per week, the participant will also be asked to complete a post-VR questionnaire which will ask questions about presence felt in the headset, any physical discomfort while in the headset, and their feelings about the headset. During the last session, treatment and skills will be reviewed and the participant will be asked to provide verbal feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Enhanced BA | Experimental | Participants will perform all of their behavioral activation in virtual reality (VR). Participants will meet with the clinician once a week for four weeks (5 sessions). In between weekly therapy sessions, participants will be asked to pick at least one pleasurable activity to enjoy in VR per day. Participants will complete their post-VR surveys and add and schedule activities on separate worksheets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-Enhanced BA | Behavioral | Participants will choose at least one "activity" per day to complete in the loaned HTC VIVE Flow Immersive Glasses extended reality over the course of the week. These activities are chosen from the headset and include video 360. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Scores on the GDS-15 From Baseline to Session 5 | How participants' depression scores on the Geriatric Depression Scale (GDS-15) change over time using VR-enhanced BA. The GDS-15 is a 15-question screener with a score range of 0-15, with 15 indicating the most severe depression and 0 indicating a lack of depression symptoms. The greater the change over time, the greater the symptom reduction. | Assessed at the beginning of sessions 1, 2, 3, 4, and 5 (days 1, 8, 15, 22, and 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Desire to Continue Using Virtual Reality (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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margot Paul, PsyD | Contact | 510-556-0157 | mdpaul@stanford.edu | |
| Kim Bullock, MD | Contact | 650-714-1459 | kbullock@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Margot Paul, PsyD | Stanford University | Principal Investigator |
| Kim Bullock, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94304 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Assessed after session 5, at the end of week 4. |
| Participant's Satisfaction With the VR-Enhanced 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 after session 5, at the end of week 4 |
| Participant's Use of the VR Headset | This was measured by noting the amount of times the XR headset is used during the 4-week study period. | Assessed after session 5, at the end of week 4. |
| Participant's Acceptance of VR-Enhanced 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 after session 5, at the end of week 4. |
| How Well Can Participants Tolerate the VR-Enhanced 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 after session 5, at the end of week 4. |
| How Present Did Individuals in the VR-Enhanced BA Treatment Feel in the Headset? | 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 after session 5, at the end of week 4. |
| D001523 |
| Mental Disorders |