Clinical trial NCT05342077: Virtual Reality-Reward Training for Anhedonia
Official title: Virtual Reality-Reward Training for Anhedonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Positive Affect
Depression
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression, Anxiety, and Stress Scales (DASS-21)
timeFrame: Change from baseline to follow-up (Week 12)
measure: The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS X) (General Dimensions Scales)
timeFrame: Change from baseline to follow-up (Week 12)
measure: MASQ-AD 14 Item
timeFrame: Change from baseline to follow-up (Week 12)
Secondary outcomes:
measure: Behavioral Activation Scale (BAS)
timeFrame: Change from baseline to follow-up (Week 12)
measure: Work and Social Functioning Scale (WSAS)
timeFrame: Change from baseline to follow-up (Week 12)
measure: Positive and Negative Affective Schedule (PANAS)
timeFrame: Change from baseline to follow-up (Week 12)
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: Change from baseline to follow-up (Week 12)
measure: Effort Reward Trade-off Task
timeFrame: Change from baseline to follow-up (Week 12)
measure: Positive Valence Systems Scale (PVSS-21)
timeFrame: Change from baseline to follow-up (Week 12)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michelle G Craske, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: