Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorStanford University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • VR-Enhanced BA

    Behavioral

    Participants 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

30 Participants
are divided into 1 treatment group
Group A: VR-Enhanced BAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at the beginning of sessions 1, 2, 3, 4, and 5 (days 1, 8, 15, 22, and 29)

Secondary outcomes

1

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).

Time frame
Assessed after session 5, at the end of week 4.
2

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).

Time frame
Assessed after session 5, at the end of week 4
3

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.

Time frame
Assessed after session 5, at the end of week 4.
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).

Time frame
Assessed after session 5, at the end of week 4.

Other outcomes

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