Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-Enhanced BA.
- Who it may be relevant to
- Registry conditions: Depression - Major Depressive Disorder, Older Adults (65 Years and Older), Behavioral Activation Treatment, Virtual Reality Therapy. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
VR-Enhanced BA for Older Adults With Major Depressive Disorder
Overview
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.
Detailed description
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.
Interventions
- Behavioral VR-Enhanced BA
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.
Primary outcome measures
- Change in Depression Scores on the GDS-15 From Baseline to Session 5 [Time frame: Assessed at the beginning of sessions 1, 2, 3, 4, and 5 (days 1, 8, 15, 22, and 29)]
Secondary outcome measures (6)
- Participant's Desire to Continue Using Virtual Reality (VR) After the Study Ends [Time frame: Assessed after session 5, at the end of week 4.]
- Participant's Satisfaction With the VR-Enhanced BA Treatment [Time frame: Assessed after session 5, at the end of week 4]
- Participant's Use of the VR Headset [Time frame: Assessed after session 5, at the end of week 4.]
- Participant's Acceptance of VR-Enhanced BA Treatment [Time frame: Assessed after session 5, at the end of week 4.]
- How Well Can Participants Tolerate the VR-Enhanced BA Treatment? [Time frame: Assessed after session 5, at the end of week 4.]
- How Present Did Individuals in the VR-Enhanced BA Treatment Feel in the Headset? [Time frame: Assessed after session 5, at the end of week 4.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Current suicidal urges and intent
- Changing psychotherapy treatment within three months of study entry
- Changing psychotropic medication(s) within two months of study entry
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT07188623 · IRB-80275