Mobile Virtual Positive Experiences for Anhedonia

NCT03715400 | Suspended

• 1 other identifier: Mobile Virtual Reality Study
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Anhedonia; Virtual Reality; Depression; Mood Disorders; Stress; Anxiety

Keywords

Virtual Reality; Depression; Stress; Anxiety; Treatment

Outcome Measures

Primary Outcomes (1)

• Change in anhedonia

  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)

  Baseline to Post-treatment (4 weeks)

Study Arms (2)

Control

NO INTERVENTION

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.

Positive Virtual Reality Training Intervention

EXPERIMENTAL

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

Interventions

Positive Virtual Reality Training BEHAVIORAL

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.

Also known as: Mobile Virtual Reality Training

Positive Virtual Reality Training Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Anhedonia; Depression; Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michelle Craske, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: September 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)