Social Anxiety DisorderNCT05261659
Targeted Memory Reactivation During REM Sleep in Patients With Social Anxiety Disorder
A study testing Exposure Therapy and Targeted memory reactivation during REM sleep and Exposure Therapy in people with Social Anxiety Disorder and Sleep, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Social Anxiety Disorder, Sleep
- What is being tested?
- Exposure Therapy and Targeted memory reactivation during REM sleep and Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Feb 2020to 6 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Sleep Medicine, University Hospitals of Geneva
Geneva, 1225
About this study
Official title: 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.
- Conditions
- Social Anxiety Disorder, Sleep
- Being tested
- Exposure Therapy and Targeted memory reactivation during REM sleep, Exposure Therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Therapy and Targeted memory reactivation during REM sleepBehavioural
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 TherapyBehavioural
These patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square of the successive [R-R intervals] differences
The RMSSD is used to estimate the vagally mediated changes in heart rate variability.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 1 week
Secondary outcomes (3)
Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
Measured: 1 day
Non-specific skin conductance responses
The skin conductance response measures sympathetic nervous system activation.
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Feb 2020
- Primary completion6 Feb 2022
- Study completion6 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lampros Perogamvros, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261659
- Sponsor's protocol ID
- 2018-01335
- Other IDs
- 2018
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Sleep and Dreaming to Treat Social Anxiety
- ClinicalTrials.gov ID
- NCT05261659
- Acronym / sponsor ID
- 2018-01335
- Conditions
- Social Anxiety Disorder, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMR group | Experimental | Behavioral: Exposure Therapy and Targeted memory reactivation during REM sleepPatients 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. |
| Control group | Active comparator | Behavioral: Exposure TherapyPatients 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure Therapy and Targeted memory reactivation during REM sleepEmerging 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. | Behavioural | TMR group |
| Exposure TherapyThese patients will receive the classic treatment of Exposure Therapy (ET) for social anxiety disorder without any association with a sound. | Behavioural | Control group |
Primary outcome
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.
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.
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)
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)
3 secondary outcomes
Non-specific skin conductance responses
Time frame: 1 day
Non-specific skin conductance responses
Time frame: 1 week
Change of fear in dreams (average of fear during the second week with stimulations minus the first week without stimulations)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy and Targeted memory reactivation during REM sleep and Exposure Therapy in people with Social Anxiety Disorder and Sleep, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root mean square of the successive [R-R intervals] differences (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.