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

Using Sleep and Dreaming to Treat Social Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Exposure Therapy and Targeted memory reactivation during REM sleep; Behavioral: Exposure Therapy

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1225
    • Center for Sleep Medicine, University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Behavioral: Exposure Therapy; These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-specific skin conductance responses	The skin conductance response measures sympathetic nervous system activation.	1 day
Non-specific skin conductance responses	The skin conductance response measures sympathetic nervous system activation.	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).	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): February 6, 2022
• Study Completion (Actual): February 6, 2022

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: 2018-01335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No