About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must meet DSM V criteria for MDD
Patient must be at least 65 years of age
Patient must be English speaking
Without cognitive impairment
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
VR-Enhanced BA
BehavioralParticipants will choose at least one "activity" per day to complete in the loaned HTC VIVE Flow Immersive Glasses or the Meta Quest 3 headset extended reality over the course of the week. These activities are chosen from the headset and include video 360.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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).
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.
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).
Sponsors and contacts
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