NCT07188623

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

September 16, 2025

Last Update Submit

February 18, 2026

Conditions

Virtual Reality TherapyDepression - Major Depressive DisorderOlder Adults (65 Years and Older)Behavioral Activation Treatment

Keywords

DepressionOlder adultmajor depressive disorderMDDbehavioral activationVRvirtual realityolder adults

Outcome Measures

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.

    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

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

  • Participant's Satisfaction With the VR-Enhanced BA Treatment

    Assessed after session 5, at the end of week 4

  • Participant's Use of the VR Headset

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

  • Participant's Acceptance of VR-Enhanced BA Treatment

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

  • How Well Can Participants Tolerate the VR-Enhanced BA Treatment?

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

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: VR-Enhanced BA

Interventions

VR-Enhanced BABEHAVIORAL

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.

VR-Enhanced BA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Margot Paul, PsyD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Kim Bullock, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margot Paul, PsyD

CONTACT

510-556-0157mdpaul@stanford.edu

Kim Bullock, MD

CONTACT

650-714-1459kbullock@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)