Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder

Sleep Clinical Trial

Official title:

Using Sleep and Dreaming to Treat Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261659
• Other study ID #: 2018-01335
• Status: Completed
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: February 6, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 6, 2022
• Est. primary completion date: February 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Sleep
• Social Anxiety Disorder

Intervention

Behavioral:
• Exposure Therapy and Targeted memory reactivation during REM sleep
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.
• Exposure Therapy
These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.

Locations

Country	Name	City	State
Switzerland	Center for Sleep Medicine, University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	3 months
Primary	Root mean square of the successive [R-R intervals] differences	The RMSSD is used to estimate the vagally mediated changes in heart rate variability.	1 day
Primary	Root mean square of the successive [R-R intervals] differences	The RMSSD is used to estimate the vagally mediated changes in heart rate variability.	1 week
Primary	Subjective Units of Distress Scale	Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)	1 day
Primary	Subjective Units of Distress Scale	Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)	1 week
Secondary	Non-specific skin conductance responses	The skin conductance response measures sympathetic nervous system activation.	1 day
Secondary	Non-specific skin conductance responses	The skin conductance response measures sympathetic nervous system activation.	1 week
Secondary	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).	1 week