An interventional study of Exposure Therapy and Targeted memory reactivation during REM sleep and Exposure Therapy in Social Anxiety Disorder and Sleep, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Exposure Therapy and Targeted memory reactivation during REM sleep
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.
Behavioral: Exposure Therapy
Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories. By using targeted memory reactivation (TMR), a known method where a sound is associated with a waking experience (i.e., positive feedback in this study) and strengthening it during REM sleep, the investigators aim to accelerate the remission of social anxiety disorder.
These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.
Root mean square of the successive [R-R intervals] differences
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Time frame: 1 day
Root mean square of the successive [R-R intervals] differences
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Time frame: 1 week
Subjective Units of Distress Scale
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Time frame: 1 day
Subjective Units of Distress Scale
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Time frame: 1 week
Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
Time frame: 1 day
Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
Time frame: 1 week
Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)
Use of a dream diary where the emotion of fear is graded in a dichotomous way (presence/absence).
Time frame: 1 week
Liebowitz Social Anxiety Scale
Validated self-report measure used to assess degree of social anxiety on a scale of 0 to 144 (higher values reflect a worse outcome)
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva