Clinical trial NCT05525390: Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Official title: Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
MDD
Depression
Keywords: Extended Reality
Virtual Reality
Behavioral Activation
Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either XR-enhanced behavioral activation or traditional behavioral activation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms
timeFrame: Assessed at baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
Secondary outcomes:
measure: Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends
timeFrame: Assessed after session 4, at the end of week 3.
measure: Number of Participants Who Dropped Out of Each Study Arm
timeFrame: 3-weeks
measure: Participant's Satisfaction With the XR-Enhanced BA Treatment
timeFrame: Assessed after session 4, at the end of week 3.
measure: Participant's Use of the XR Headset
timeFrame: Assessed after session 4, at the end of week 3.
measure: Participant's Acceptance of XR-Enhanced BA Treatment
timeFrame: Assessed after session 4, at the end of week 3.
measure: How Well Can Participants Tolerate the XR-Enhanced BA Treatment?
timeFrame: Assessed after session 4, at the end of week 3.
measure: How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?
timeFrame: Assessed after session 4, at the end of week 3.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Margot D Paul, Psy.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Kim Bullock, M.D.
role: STUDY_CHAIR
References: