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Completed

NCT Number: NCT04268316

Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major MDD Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

This is a treatment development trial. Participants will be randomly assigned to BA in VR, BA in real-life, or a waitlist control group. The former two groups will follow a BA protocol developed for primary care settings over a four-week treatment period. This study is taking place over Zoom, due to COVID-19.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 I disorder
  • Any seizure in the last 6 months or untreated epilepsy
  • Current nonsuicidal self-injury or parasuicidal behavior
  • Current suicidal urges and intent

Treatment and study plan

Virtual Reality Behavioral Activation

Device

Participants will choose four "activities" to complete in virtual reality over the course of the week. These activities are video 360 and range from viewing animals, to viewing nature scenes, to traveling to a different location in the world, to viewing adrenaline-pumping activities.

Behavioral Activation in real-life

Behavioral

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

Primary outcomes

  1. Participant's Desire to Continue Using VR After the Study Ends

    Time frame: Assessed at the end of week 3, after session 4

    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).

  2. Number of Participants Who Dropped Out of Each Study Arm

    Time frame: 3-weeks

    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. Participant's Satisfaction With the VR-BA Treatment

    Time frame: Assessed at the end of week 3, after session 4

    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).

  4. Participant's Use of the VR Headset

    Time frame: Assessed at the end of week 3, after session 4

    This was measured by noting the amount of times the VR headset is used during the 3-week study period.

  5. Participant's Acceptance of VR-BA Treatment

    Time frame: Assessed at the end of week 3, after session 4

    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).

  6. How Well Can Participants Tolerate the VR-BA Treatment?

    Time frame: Assessed at the end of week 3, after session 4

    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).

  7. How Present Did Individuals in the VR-BA Treatment Feel?

    Time frame: Assessed at the end of week 3, after session 4

    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).

Secondary outcomes

  1. Change in Depression Scores on the PHQ-9 From Baseline to Session 4, Compared Across Three Study Arms

    Time frame: Assessed at baseline and session 4.

    How participants' depression scores on the Patient Health Questionnaire (PHQ-9) change over time using VR-BA compared to BA in real life and a waitlist control. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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