Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Depression Clinical Trial

Official title:

Extended Reality Behavioral Activation: An Intervention for Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525390
• Other study ID #: 66488
• Status: Completed
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: July 24, 2023

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Both Study Arms	How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using XR-BA compared to BA in real life. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 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 baseline and beginning of sessions 1, 2, 3 and 4 (days 1, 8, 15, 22).
Secondary	Participant's Desire to Continue Using Extended Reality (XR) After the Study Ends	This outcome was measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 3 questions, the total range was 0-12 (higher scores indicate greater acceptance).	Assessed after session 4, at the end of week 3.
Secondary	Number of Participants Who Dropped Out of Each Study Arm	Participant treatment dropout was compared across each study arm. This was reported as the count of participants who discontinued the study for any reason.	3-weeks
Secondary	Participant's Satisfaction With the XR-Enhanced BA Treatment	This outcome was measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4). With 4 questions, the total range was 0-16 (higher scores indicate greater acceptance).	Assessed after session 4, at the end of week 3.
Secondary	Participant's Use of the XR Headset	This was measured by noting the amount of times the XR headset is used during the 3-week study period.	Assessed after session 4, at the end of week 3.
Secondary	Participant's Acceptance of XR-Enhanced BA Treatment	This was measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), or Strongly Agree (4), yielding a range of 0-52 (higher scores indicate greater acceptance).	Assessed after session 4, at the end of week 3.
Secondary	How Well Can Participants Tolerate the XR-Enhanced BA Treatment?	This was determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual (0), Slightly more than usual (1), Moderately more than usual (2), or Severely more than usual (3), yielding a range of 0-48 (lower scores indicate greater tolerability).	Assessed after session 4, at the end of week 3.
Secondary	How Present Did Individuals in the XR-Enhanced BA Treatment Feel in the Headset?	This was measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all (0), Slightly (1), Moderately (2), Strongly (3), or Very Strongly (4), yielding a range of 0-12 (higher scores indicate greater presence).	Assessed after session 4, at the end of week 3.