Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2023-07-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder MDD Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Behavioral Activation

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.

Group Type ACTIVE_COMPARATOR

Traditional Behavioral Activation

Intervention Type BEHAVIORAL

Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.

XR-Enhanced Behavioral Activation

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.

Group Type EXPERIMENTAL

Extended Reality-Enhanced Behavioral Activation

Intervention Type BEHAVIORAL

Participants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.

Interventions

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Extended Reality-Enhanced Behavioral Activation

Participants will choose at least four "activities" to complete in Oculus extended reality over the course of the week. These activities are chosen from the Oculus and may include video 360, social interactions, gaming, etc.

Intervention Type BEHAVIORAL

Traditional Behavioral Activation

Participants will choose at least four pleasurable and/or mastery activities to complete over the course of the week in real life.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No