Depression, Major Depressive Disorder, MDD
Conditions
Keywords
Extended Reality, Virtual Reality, Behavioral Activation, Depression
Brief summary
The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.
Detailed description
This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.
Interventions
BEHAVIORALExtended Reality-Enhanced Behavioral Activation
Participants will choose at least four activities to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.
BEHAVIORALTraditional Behavioral Activation
Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.
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 disorder * Any seizure in the last 6 months or untreated epilepsy * Current nonsuicidal self-injury or parasuicidal behavior * Current suicidal urges and intent * Changing psychotherapy treatment within four months of study entry * Changing psychotropic medication(s) within two months of study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms | Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22). | How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 XR-Enhanced BA Treatment | Assessed after session 4, at the end of week 3. | 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 XR Headset | Assessed after session 4, at the end of week 3. | This was measured by noting the amount of times the XR headset is used during the 3-week study period. |
| Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends | Assessed after session 4, at the end of week 3. | 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). |
| How Well Can Participants Tolerate the XR-Enhanced BA Treatment? | Assessed after session 4, at the end of week 3. | 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). |
| How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset? | Assessed after session 4, at the end of week 3. | 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 Acceptance of XR-Enhanced BA Treatment | Assessed after session 4, at the end of week 3. | 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). |
Countries
United States
Outcome results
None listed