Depression - Major Depressive DisorderNCT07188623
Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression
A study testing VR-Enhanced BA in people with Depression - Major Depressive Disorder and Older Adults (65 Years and Older), run by Stanford University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Older Adults (65 Years and Older), Behavioral Activation Treatment
- What is being tested?
- VR-Enhanced BA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94304
Margot Paul, PsyD, 510-556-0157, mdpaul@stanford.edu
Kim Bullock, MD, 650-714-1459, kbullock@stanford.edu
About this study
Official title: VR-Enhanced BA for Older Adults With Major Depressive Disorder
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.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder, Older Adults (65 Years and Older), Behavioral Activation Treatment, Virtual Reality Therapy
- Being tested
- VR-Enhanced BA
- Keywords
- Depression, Older adult, major depressive disorder, MDD, behavioral activation, VR, virtual reality, older adults
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Enhanced BABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VR-Enhanced BA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the beginning of sessions 1, 2, 3, 4, and 5 (days 1, 8, 15, 22, and 29)
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Assessed after session 5, at the end of week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margot Paul, PsyD, Stanford University
- Investigators
- Margot Paul, PsyD, Principal investigator, Stanford UniversityKim Bullock, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188623
- Sponsor's protocol ID
- IRB-80275
- Status last verified
- Aug 2026
- First submitted
- 16 Sep 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-Enhanced BA for Older Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07188623
- Acronym / sponsor ID
- IRB-80275
- Conditions
- Depression - Major Depressive Disorder, Older Adults (65 Years and Older), Behavioral Activation Treatment, Virtual Reality Therapy
- Keywords
- Depression, Older adult, major depressive disorder, MDD, behavioral activation, VR, virtual reality, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-Enhanced BA | Experimental | Behavioral: VR-Enhanced BAParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Enhanced BAParticipants 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. | Behavioural | VR-Enhanced BA |
Primary outcome
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)
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margot Paul, PsyD principal investigator
Stanford University
Kim Bullock, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Enhanced BA in people with Depression - Major Depressive Disorder and Older Adults (65 Years and Older), run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margot Paul, PsyD (510-556-0157, mdpaul@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.