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

NCT ID: NCT05261659

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2022-02-06

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.

Conditions

Social Anxiety Disorder; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure Therapy and Targeted memory reactivation during REM sleep

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type: BEHAVIORAL

These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.

Interventions

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.

Intervention Type: BEHAVIORAL

Exposure Therapy

These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Lampros Perogamvros

Senior Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Sleep Medicine, University Hospitals of Geneva

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2018-01335

Identifier Type: -

Identifier Source: org_study_id