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

NCT05261659 | Completed

• 1 other identifier: 2018-01335
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Non-specific skin conductance responses

  1 day

• Non-specific skin conductance responses

  1 week

• Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)

  1 week

Other Outcomes (1)

• Liebowitz Social Anxiety Scale

  3 months

Study Arms (2)

TMR group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Exposure Therapy and Targeted memory reactivation during REM sleep 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.

TMR group

Exposure Therapy BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Center for Sleep Medicine, University Hospitals of Geneva

Geneva, 1225, Switzerland

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Fellow

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 2, 2022
• Study Start: February 18, 2020
• Primary Completion: February 6, 2022
• Study Completion: February 6, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)