Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Stanford University

Status: Completed

Conditions: Major Depressive Disorder; Depression; MDD

Treatments: Behavioral: Extended Reality-Enhanced Behavioral Activation; Behavioral: Traditional Behavioral Activation

Study type: Interventional

Funder types: Other

Identifiers

NCT05525390

66488

Details and patient eligibility

About

The primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (XR) headset to engage in behavioral activation (BA) for individuals diagnosed with major depressive disorder (MDD). The secondary aim of this study is to explore the efficacy of using XR to enhance BA therapy in a clinical MDD population.

Full description

This is a treatment development trial. Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation. All groups will follow a brief-BA protocol developed for primary care settings over a four-session, three-week treatment period.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must meet DSM V criteria for MDD
• Patient must be at least 18 years of age
• Patient must be English speaking

Exclusion criteria

• Substance Use Disorders in past year
• Any psychosis or bipolar 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 four months of study entry
• Changing psychotropic medication(s) within two months of study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Traditional Behavioral Activation

Active Comparator group

Description:

Participants randomized to this arm will perform all of their behavioral activation in real life. Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick four pleasurable or mastery activities to perform in real life. Participants will complete the PHQ-9 and their activity monitoring and scheduling on separate worksheets.

Treatment:

Behavioral: Traditional Behavioral Activation

XR-Enhanced Behavioral Activation

Experimental group

Description:

Participants randomized to this arm will perform all of their behavioral activation in extended reality (XR). Participants will meet with the clinician once a week for three weeks (4 sessions). In between weekly therapy sessions, participants will pick at least four pleasurable activities to enjoy in extended reality. Participants will complete their post-XR surveys and add and schedule activities on separate worksheets.

Treatment:

Behavioral: Extended Reality-Enhanced Behavioral Activation