Clinical trial NCT05261659: Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder
Official title: Using Sleep and Dreaming to Treat Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Sleep
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Root mean square of the successive [R-R intervals] differences
timeFrame: 1 day
measure: Root mean square of the successive [R-R intervals] differences
timeFrame: 1 week
measure: Subjective Units of Distress Scale
timeFrame: 1 day
measure: Subjective Units of Distress Scale
timeFrame: 1 week
Secondary outcomes:
measure: Non-specific skin conductance responses
timeFrame: 1 day
measure: Non-specific skin conductance responses
timeFrame: 1 week
measure: Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)
timeFrame: 1 week
Other outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: 3 months
Locations:
city: Geneva
country: Switzerland
facility: Center for Sleep Medicine, University Hospitals of Geneva
Study officials:
References: