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Completed

NCT Number: NCT05261659

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

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Sleep

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Sleep Medicine, University Hospitals of Geneva

Geneva, 1225, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Exposure Therapy

Behavioral

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

Primary outcomes

  1. Root mean square of the successive [R-R intervals] differences

    Time frame: 1 day

    The RMSSD is used to estimate the vagally mediated changes in heart rate variability.

  2. Root mean square of the successive [R-R intervals] differences

    Time frame: 1 week

    The RMSSD is used to estimate the vagally mediated changes in heart rate variability.

  3. Subjective Units of Distress Scale

    Time frame: 1 day

    Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)

  4. Subjective Units of Distress Scale

    Time frame: 1 week

    Validated rating of subjective distress on a scale of 0 to 10 (higher values reflect a worse outcome)

Secondary outcomes

  1. Non-specific skin conductance responses

    Time frame: 1 day

    The skin conductance response measures sympathetic nervous system activation.

  2. Non-specific skin conductance responses

    Time frame: 1 week

    The skin conductance response measures sympathetic nervous system activation.

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

    Time frame: 1 week

    Use of a dream diary where the emotion of fear is graded in a dichotomous way (presence/absence).

Other outcomes

  1. Liebowitz Social Anxiety Scale

    Time frame: 3 months

    Validated self-report measure used to assess degree of social anxiety on a scale of 0 to 144 (higher values reflect a worse outcome)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Using Sleep and Dreaming to Treat Social Anxiety

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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