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Mobile Virtual Positive Experiences for Anhedonia (MVR)

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ClinicalTrials.gov Identifier: NCT03715400
Recruitment Status : Suspended (COVID-19 Restrictions for in-person study procedures)
First Posted : October 23, 2018
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles

Brief Summary:
Anhedonia is a symptom dimension that characterizes many individuals suffering from depression, as well as some types of anxiety, psychosis, and substance use. For the most part, treatments are effective in decreasing negative affect but ineffective in improving anhedonia, with some antidepressant medications even worsening symptoms of anhedonia. Yet anhedonia is a significant marker of poor prognosis as well as suicidal ideation and actual suicide. The development of effective treatments for anhedonia is thus of paramount importance. Advances in neuroscience indicate specific targets that may underlie anhedonia that can be shifted through behavioral training. The investigators have developed such a program and found it to be effective in raising positive affect, especially for depressed or anxious individuals with anhedonia at baseline. To date, this program has been implemented by highly trained clinicians, which have supervised its implementation on a large scale. Moreover, the behavior program is dependent on readily available rewarding experiences, which anhedonia obviously challenges. Furthermore, mechanistic evaluation is impeded by intra¬- and inter-¬individual variability in exposure to rewarding stimuli. Virtual Reality (VR) offsets these barriers by repeated controlled immersion in experiences designed to enhance approach motivation, initial responsiveness to reward attainment, and reward learning. In this current study, the investigators aim to measure clinical outcomes using Virtual Reality-Reward Training (VR-RT).

Condition or disease Intervention/treatment Phase
Anhedonia Virtual Reality Depression Mood Disorders Stress Anxiety Behavioral: Positive Virtual Reality Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mobile Virtual Positive Experiences for Anhedonia
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control
The control group will not undergo the positive virtual reality training program. Instead, they will complete all self-report and behavioral measures and have the option to experience the positive virtual reality training program upon the conclusion of the study.
Experimental: Positive Virtual Reality Training Intervention
The experimental group will undergo the positive virtual reality training program, which consists of 7 virtual reality (VR) sessions to be completed at home after orientation to the program, in addition to all self-report and behavioral measures.
Behavioral: Positive Virtual Reality Training
Participants will undergo 7 45 minute sessions of positive virtual reality training over the course of four weeks. All assessments will be completed online at home following initial orientation to the program.
Other Name: Mobile Virtual Reality Training




Primary Outcome Measures :
  1. Change in anhedonia [ Time Frame: Baseline to Post-treatment (4 weeks) ]
    Change in anhedonia as measured by the anhedonia subscale of the Mood and Anxiety Symptom Questionnaire (MASQ) (max: 110, min: 22, with a higher score indicating higher anhedonia)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fluent in English
  • below the population mean on either the Behavioral Activation Scale (BAS) Reward Drive subscale (score of ≤ 11), or BAS Responsiveness subscale (score of ≤16)
  • score in mild-moderate range on DASS-21 following established score cutoffs: Depression (10-27); at least a score of Anxiety (8-14); and a score of at least Stress (15-25)
  • Sheehan Disability Scale (SDS) overall score must be ≥ 6
  • agree to refrain from initiating other psychosocial treatments throughout the duration of the study

Exclusion Criteria:

  • Lifetime history of bipolar disorder, psychosis, intellectual disabilities, or organic brain damage
  • substance use disorder in the past 6 months
  • current use of psychotropic medications
  • currently pregnant or planning to become pregnant
  • self-reported frequent motion sickness, self-reported seizures within the last year and/or a diagnosis of epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715400


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Michelle Craske, PhD University of California, Los Angeles
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Responsible Party: Michelle Craske, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03715400    
Other Study ID Numbers: Mobile Virtual Reality Study
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Craske, University of California, Los Angeles:
Virtual Reality
Depression
Stress
Anxiety
Treatment
Additional relevant MeSH terms:
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Anhedonia
Depression
Mood Disorders
Behavioral Symptoms
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases