Using Sleep and Dreaming to Treat Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Subjective Units of Distress Scale
研究概览
简要总结
With this study, the investigators aim to use sleep and dreaming in order to enhance exposure therapy for social anxiety disorder (SAD), by pairing the positive feedback phase of exposure (public talk) to an auditory stimulus during wake (associated sound) and subsequently applying this stimulus during sleep (targeted memory reactivation, TMR). Exposure therapy sessions will take place in a virtual reality (VR) environment, while physiological measures during the preparation phase of public talk such as heart rate variability (HRV), skin conductance response (SCR) and subjective level of anxiety (SUDS) will be used in order to assess treatment efficiency across the sessions. Patients with SAD according to DSM-5 criteria will be included.
The main hypothesis of this study is that participants who are presented with the associated sound during sleep (TMR group) will have reduced intensity of social anxiety compared to participants with no such association (control group), after both a full night's sleep with auditory stimulation during REM sleep in the laboratory, and after 1 week of stimulation during REM sleep at home. In addition, it is expected that fear-related dreams may correlate with anxiety levels during wakefulness after 1 week of stimulation at home.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with social anxiety disorder (according to DSM-5 criteria and Liebowitz Social Anxiety Scale > 65)
- •aged between 16 and 40 yo
- •no current treatment for SAD (cognitive-behavioral therapy, medications)
排除标准
- •mood disorder, psychosis,other anxiety disorder or other mental disorders according to DSM-5 criteria
- •sleep disorder (e.g.,insomnia disorder, obstructive sleep apnea syndrome, restless legs syndrome) according to DSM-5 criteria
- •use of psychiatric medication
- •current treatment for SAD (cognitive-behavioral therapy, medications)
- •neurological disease
研究组 & 干预措施
TMR group
Patients will receive a sound while they receive a positive feedback for their performance of exposure therapy (ET). They will also receive the sound during REM sleep.
干预措施: Exposure Therapy and Targeted memory reactivation during REM sleep (Behavioral)
Control group
Patients will not receive a sound while they receive a positive feedback for their performance of exposure therapy (ET). They will receive the same sound as the experimental group during REM sleep under the same conditions.
干预措施: Exposure Therapy (Behavioral)
结局指标
主要结局
Subjective Units of Distress Scale
时间窗: 1 week
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Root mean square of the successive [R-R intervals] differences
时间窗: 1 week
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Root mean square of the successive [R-R intervals] differences
时间窗: 1 day
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Subjective Units of Distress Scale
时间窗: 1 day
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
次要结局
- Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)(1 week)
- Non-specific skin conductance responses(1 week)
- Non-specific skin conductance responses(1 day)
研究者
Lampros Perogamvros
Senior Clinical Fellow
University Hospital, Geneva