Virtual Reality-Enhanced Behavioral Activation for Older Adults With Depression

NCT ID: NCT07188623

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-Enhanced BA

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.

Group Type: EXPERIMENTAL

VR-Enhanced BA

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Margot Paul, PsyD

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margot Paul, PsyD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Kim Bullock, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margot Paul, PsyD

Role: CONTACT

mdpaul@stanford.edu

510-556-0157

Kim Bullock, MD

Role: CONTACT

kbullock@stanford.edu

650-714-1459

Facility Contacts

Margot Paul, PsyD

Role: primary

mdpaul@stanford.edu

510-556-0157

Kim Bullock, MD

Role: backup

kbullock@stanford.edu

650-714-1459

Other Identifiers

IRB-80275

Identifier Type: -

Identifier Source: org_study_id