search
Back to results

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

Primary Purpose

Social Anxiety Disorder, Sleep

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exposure Therapy and Targeted memory reactivation during REM sleep
Exposure Therapy
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Sleep Medicine, University Hospitals of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TMR group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Root mean square of the successive [R-R intervals] differences
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Root mean square of the successive [R-R intervals] differences
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Subjective Units of Distress Scale
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Subjective Units of Distress Scale
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)

Secondary Outcome Measures

Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
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).

Full Information

First Posted
February 19, 2022
Last Updated
March 1, 2022
Sponsor
University Hospital, Geneva
search

1. Study Identification

Unique Protocol Identification Number
NCT05261659
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 6, 2022 (Actual)
Study Completion Date
February 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Therapy and Targeted memory reactivation during REM sleep
Intervention Description
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
Intervention Name(s)
Exposure Therapy
Intervention Description
These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.
Primary Outcome Measure Information:
Title
Root mean square of the successive [R-R intervals] differences
Description
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Time Frame
1 day
Title
Root mean square of the successive [R-R intervals] differences
Description
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Time Frame
1 week
Title
Subjective Units of Distress Scale
Description
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Time Frame
1 day
Title
Subjective Units of Distress Scale
Description
Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Non-specific skin conductance responses
Description
The skin conductance response measures sympathetic nervous system activation.
Time Frame
1 day
Title
Non-specific skin conductance responses
Description
The skin conductance response measures sympathetic nervous system activation.
Time Frame
1 week
Title
Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)
Description
Use of a dream diary where the emotion of fear is graded in a dichotomous way (presence/absence).
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Liebowitz Social Anxiety Scale
Description
Validated self-report measure used to assess degree of social anxiety on a scale of 0 to 144 (higher values reflect a worse outcome)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Center for Sleep Medicine, University Hospitals of Geneva
City
Geneva
ZIP/Postal Code
1225
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs