Virtual Reality-Reward Training for Anhedonia (VR-RT)

The purpose of this study is to compare the effects of Virtual Reality-Reward Training (VR-RT) with an active control condition, Virtual Reality-Memory Training (VR-MT), on positive affect and other clinical symptoms.

VR-Reward Training is a novel intervention aimed at enhancing savoring of positive experiences among individuals with depression and low positive affect through guided imaginal recounting following immersion in positive VR experiences.

Target enrollment is 80 male and female participants with low positive affect, depression, and impaired functioning, who are at least 18 years old, who will be randomly assigned to 7 weeks of either Virtual Reality-Reward Training (VR-RT) or Virtual Reality-Memory Training (VR-MT). Participants will complete in-person VR sessions, laboratory assessments, self-report questionnaires as part of the study.

The total length of participation is around 3 months.

Study Overview

• Status: Recruiting
• Conditions: Depression; Positive Affect
• Intervention / Treatment: Behavioral: Virtual Reality-Reward Training (VR-RT); Behavioral: Virtual Reality-Memory Training (VR-MT)

Detailed Description

Anhedonia, or loss of interest and pleasure in usual activities, has been relatively resistant to pharmacological and psychological treatments in the context of anxiety and depression. Newer treatments that focus upon positivity or reward sensitivity have shown promising results.

The purpose of the current randomized controlled trial is to compare the effects of Virtual Reality-Reward Training (VR-RT) with an active control condition, Virtual Reality-Memory Training (VR-MT), on positive affect and other clinical symptoms. Virtual Reality-Reward Training is designed to augment reward sensitivity in individuals with depression and low positive affect. Targets include behavioral, cognitive, and self-report indices of reward anticipation and initial response to reward. Specificity of target engagement is assessed by comparison with Virtual Reality-Memory Training, designed to improve memory.

Targets and clinical outcomes are assessed at baseline (Week 1) and either weekly or at mid-treatment (Week 3), post-treatment (Week 7), and follow-up (Week 12). Statistical models evaluate whether change in outcomes and change in target measures are greater as a result of Virtual Reality-Reward Training compared to Virtual-Reality-Memory Training and whether changes in target measures correlate with changes in outcome measures.

Target enrollment is 80 male and female participants with low positive affect, depression, and impaired functioning, who are at least 18 years old, who will be randomized to Virtual Reality-Reward Training or Virtual-Reality Memory Training, each comprising 7 individual virtual reality training sessions over the course of 7 weeks.

Participants will complete laboratory tests and self-report questionnaires as part of the study. Total length of participation is around 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Brooke Cullen, B.A.; Phone Number: 3109904459; Email: brookecullen@psych.ucla.edu
• Study Contact Backup: Name: Courtney Forbes, Ph.D; Email: cforbes@psych.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Contact: Brooke Cullen, BA; Phone Number: 310-990-4459; Email: brookecullen@psych.ucla.edu
      • Principal Investigator: Michelle Craske, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 18 years old
2. Fluent in written and spoken English

3. Meet all of the following dimensional score cutoffs:

   1. Score on the DASS-21 depression subscale must be ≥ 11
   2. Score on the PANAS-P of 24 or lower
   3. Score on the SDS of ≥ 6
4. Willingness to refrain from initiating other psychosocial treatments throughout the duration of the study

Exclusion Criteria:

1. Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
2. Substance use disorder in the past 6 months
3. Current use of psychotropic medications
4. Currently pregnant or planning to become pregnant
5. Self-reported frequent motion sickness
6. Self-reported seizures within the last year and/or a diagnosis of epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality-Reward Training (VR-RT); 7 sessions of positive VR immersion and positive memory specificity training exercises designed to savor rewarding features of immersion followed by memory specificity training exercises to savor rewarding features of autobiographical memory.	Behavioral: Virtual Reality-Reward Training (VR-RT); Participants will complete verbal recounting (present-tense, field perspective, positive details) and guided imaginal recounting of positive details for rewarding VR experiences and positive autobiographical memories.
Active Comparator: Virtual Reality-Memory Training (VR-MT); 7 sessions of neutral VR immersion and neutral memory specificity training exercises, designed to train memory of objective non-emotional stimuli followed by memory exercises to neutral autobiographical memories.	Behavioral: Virtual Reality-Memory Training (VR-MT); Participants will complete verbal recounting (past-tense, observer perspective, objective details) and guided imaginal recounting of neutral details for neutral VR experiences and neutral autobiographical memories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety, and Stress Scales (DASS-21)	Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.	Change from baseline to follow-up (Week 12)
The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS X) (General Dimensions Scales)	Change in reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50, higher scores represent higher levels of positive affect or negative affect).	Change from baseline to follow-up (Week 12)
MASQ-AD 14 Item	Change in reported anhedonia (score range: 14-70), with higher scores indicating greater anhedonic symptom severity	Change from baseline to follow-up (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Activation Scale (BAS)	Change in reported reward sensitivity (score range: 23-92), with higher scores indicating higher reward sensitivity	Change from baseline to follow-up (Week 12)
Positive and Negative Affective Schedule (PANAS)	Change in reported positive affect and negative affect (score range for each scale: 10-50, higher scores indicate higher levels of positive affect or negative affect)	Change from baseline to follow-up (Week 12)
Effort Reward Trade-off Task	Change in behavioral effort for reward (button presses for points) and experience of reward (happiness ratings). The Effort Reward Trade-off Task is a novel online behavioral task.	Change from baseline to follow-up (Week 12)
Temporal Experience of Pleasure Scale (TEPS)	Change in reported anticipatory pleasure (score range: 10-60) and consummatory pleasure (score range: 8-48). Higher scores indicate higher reward responsiveness.	Change from baseline to follow-up (Week 12)
Positive Valence Systems Scale (PVSS-21)	Change in reward anticipation, motivation, and consumption for rewards such as rewards such as food, physical touch, positive feedback, social interactions, hobbies and goals (score range: 21-105). Higher scores (e.g. 105) indicate higher reward responsiveness.	Change from baseline to follow-up (Week 12)
Work and Social Functioning Scale (WSAS)	Change in impairment in the following life domains: work (score range: 0-8), home management (score range: 0-8), social leisure (score range: 0-8), private leisure (score range: 0-8) and personal or family relationships (score range: 0-8).	Change from baseline to follow-up (Week 12)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Michelle G Craske, Ph.D, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Anhedonia
• Other Study ID Numbers: Virtual Reality Training Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No