Virtual Reality-Reward Training for Anhedonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Depression, Anxiety, and Stress Scales (DASS-21)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Depression, Anxiety, and Stress Scales (DASS-21)
时间窗: Change from baseline to follow-up (Week 12)
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)
时间窗: Change from baseline to follow-up (Week 12)
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).
MASQ-AD 14 Item
时间窗: Change from baseline to follow-up (Week 12)
Change in reported anhedonia (score range: 14-70), with higher scores indicating greater anhedonic symptom severity
次要结局
- Behavioral Activation Scale (BAS)(Change from baseline to follow-up (Week 12))
- Work and Social Functioning Scale (WSAS)(Change from baseline to follow-up (Week 12))
- Positive and Negative Affective Schedule (PANAS)(Change from baseline to follow-up (Week 12))
- Effort Reward Trade-off Task(Change from baseline to follow-up (Week 12))
- Temporal Experience of Pleasure Scale (TEPS)(Change from baseline to follow-up (Week 12))
- Positive Valence Systems Scale (PVSS-21)(Change from baseline to follow-up (Week 12))
研究者
Michelle Craske
Principal Investigator
University of California, Los Angeles