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

Primary Purpose

Positive Affect, Depression

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality-Reward Training (VR-RT)
Virtual Reality-Memory Training (VR-MT)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Positive Affect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality-Reward Training (VR-RT)

Virtual Reality-Memory Training (VR-MT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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.
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).

Secondary Outcome Measures

Behavioral Activation Scale (BAS)
Change in reported reward sensitivity (score range: 23-92), with higher scores indicating higher reward sensitivity
Sheehan Disability Scale (SDS)
Change in impairment in the following life domains: Work/school (score range: 0-10), Social life (score range: 0-10), and Family life/home responsibilities (score range: 0-10)
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)
Temporal Experience of Pleasure Scale (TEPS)
Change in reported anticipatory pleasure (score range: 10-60) and consummatory pleasure (score range: 8-48)
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.
Modified Probe Detection Task (DOTPROBE)
Change in attentional engagement with positive and negative stimuli (happy and sad faces). Behavioral task in which engagement bias is indexed by reaction time.
MASQ-AD 14 Item
Change in reported anhedonia (score range: 14-70), with higher scores indicating greater anhedonic symptom severity

Full Information

First Posted
March 16, 2022
Last Updated
December 13, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05342077
Brief Title
Virtual Reality-Reward Training for Anhedonia
Acronym
VR-RT
Official Title
Virtual Reality-Reward Training for Anhedonia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive Affect, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality-Reward Training (VR-RT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Reality-Memory Training (VR-MT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality-Reward Training (VR-RT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality-Memory Training (VR-MT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive Valence Systems Scale (PVSS-21)
Description
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)
Time Frame
Change from baseline to follow-up (Week 12)
Title
Depression, Anxiety, and Stress Scales (DASS-21)
Description
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.
Time Frame
Change from baseline to follow-up (Week 12)
Title
The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS X) (General Dimensions Scales)
Description
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).
Time Frame
Change from baseline to follow-up (Week 12)
Secondary Outcome Measure Information:
Title
Behavioral Activation Scale (BAS)
Description
Change in reported reward sensitivity (score range: 23-92), with higher scores indicating higher reward sensitivity
Time Frame
Change from baseline to follow-up (Week 12)
Title
Sheehan Disability Scale (SDS)
Description
Change in impairment in the following life domains: Work/school (score range: 0-10), Social life (score range: 0-10), and Family life/home responsibilities (score range: 0-10)
Time Frame
Change from baseline to follow-up (Week 12)
Title
Positive and Negative Affective Schedule (PANAS)
Description
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)
Time Frame
Change from baseline to follow-up (Week 12)
Title
Temporal Experience of Pleasure Scale (TEPS)
Description
Change in reported anticipatory pleasure (score range: 10-60) and consummatory pleasure (score range: 8-48)
Time Frame
Change from baseline to follow-up (Week 12)
Title
Effort Reward Trade-off Task
Description
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.
Time Frame
Change from baseline to follow-up (Week 12)
Title
Modified Probe Detection Task (DOTPROBE)
Description
Change in attentional engagement with positive and negative stimuli (happy and sad faces). Behavioral task in which engagement bias is indexed by reaction time.
Time Frame
Change from baseline to follow-up (Week 12)
Title
MASQ-AD 14 Item
Description
Change in reported anhedonia (score range: 14-70), with higher scores indicating greater anhedonic symptom severity
Time Frame
Change from baseline to follow-up (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Fluent in written and spoken English Meet all of the following dimensional score cutoffs: Score on the DASS-21 depression subscale must be ≥ 11 Score on the PANAS-P of 24 or lower Score on the SDS of ≥ 6 Willingness to refrain from initiating other psychosocial treatments throughout the duration of the study Exclusion Criteria: Lifetime history of bipolar disorder, psychosis, mental retardation, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Cullen, B.A.
Phone
3109904459
Email
brookecullen@psych.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Forbes, Ph.D
Email
cforbes@psych.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G Craske, Ph.D
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Cullen, BA
Phone
310-990-4459
Email
brookecullen@psych.ucla.edu
First Name & Middle Initial & Last Name & Degree
Michelle Craske, PhD

12. IPD Sharing Statement

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Virtual Reality-Reward Training for Anhedonia

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