Virtual Reality Training Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The Mood and Anxiety Symptoms Questionnaire - Anhedonic Depression Subscale (MASQ-AD)
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. The current study tests an enhanced version of this training using improved virtual reality technology.
Target enrollment is 80 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. A subset of 8 participants randomly assigned to VR-RT will complete fMRI scans and EMA surveys.
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 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 Week 0 Assessment (Week 0) and either weekly or at mid-treatment (Week 7), post-treatment (1 week after Session 14), 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 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 13 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 ≥ 8
- •Score on the PANAS-P of 27 or lower
- •Score on the WSAS of ≥ 11
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
研究组 & 干预措施
Virtual Reality-Memory Training (VR-MT)
13 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 non-personal stories
干预措施: Virtual Reality-Memory Training (VR-MT) (Behavioral)
结局指标
主要结局
The Mood and Anxiety Symptoms Questionnaire - Anhedonic Depression Subscale (MASQ-AD)
时间窗: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).
Change in reported anhedonia (score range: 14-70), with higher scores indicating greater anhedonic symptom severity
Positive Valence Systems Scale (PVSS-21)
时间窗: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).
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.
次要结局
- Depression, Anxiety, and Stress Scales (DASS-21)(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Positive and Negative Affective Schedule (PANAS)(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Positive and Negative Affective Schedule (PANAS-X)(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Responses to Positive Affect Questionnaire (RPA)(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Work and Social Adjustment Scale (WSAS)(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- igroup Presence Questionnaire (IPQ)(Change from Week 0 assessment to Post-Assessment (Week 8).)
- Memory Retrieval Task(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Heart Rate Variability(Change from VR Session 1 (Week 1) to VR Session 13 (Week 7).)
- State Affect(Change from VR Session 1 (Week 1) to VR Session 13 (Week 7).)
- Change in reward-relevant neural activity(Change from Week 0 Assessment to Post Assessment (Week 8))
- Blood-Based Biomarkers(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
- Depressive Symptoms Composite Score(Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).)
研究者
Michelle Craske
Principal Investigator
University of California, Los Angeles