Virtual Reality-Reward Training for Anhedonia

Depression Clinical Trial

— VR-RT  

Official title:

Virtual Reality-Reward Training for Anhedonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342077
• Other study ID #: Virtual Reality Training Study
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Brooke Cullen, B.A.
• Phone: 3109904459
• Email: brookecullen[@]psych.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Depression
• Positive Affect

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)