Social Anxiety DisorderSANAPNCT02325128
Augmentation of Exposure Therapy for High Levels of Social Anxiety Using Post-exposure Naps
A study testing Sleep-enhancement of extinction memory in people with Social Anxiety Disorder and Sleep Laboratory, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Investigators will examine whether post-exposure naps can be used to strengthen therapeutic extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the Liebowitz Social Anxiety Scale, by… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Social Anxiety Disorder, Sleep Laboratory
- What is being tested?
- Sleep-enhancement of extinction memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to Aug 2016
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Treatment-seeking individuals diagnosed with Social Anxiety Disorder using the Structured Clinical Interview for DSM-IV56 (DSM-5 SCID once available)
- A score > 60 on the Liebowitz Social Anxiety Scale (LSAS)13
- 18-40 years of age
- Proficient in English
- Normal or corrected to normal vision
- Able to give informed consent
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- Willingness and ability to comply with the requirements of the study protocol
- Meets psychophysiological screening criteria for inclusion carried out as follows:
- During a 5-min. baseline period, the candidate participant will sit quietly with skin conductance and orbicularis oculi EMG levels being recorded.
- Toward the end of this period a loud acoustic stimulus will be presented several times and blink startle EMG and SCR will be recorded.
- The candidate subject will then be asked to describe, for 2 min., their most fearful and upsetting past social experience.
- They will then be instructed to silently reimagine this experience as vividly as possible.
- During this imagination period, the loud acoustic stimulus will again be presented several times and blink startle EMG and SCR will be recorded.
- Participants for whom mean SCR and blink startle EMG during the imagining period measurably exceed the means of these measures during baseline will be retained in the study whereas those for whom these measures do not change or are reduced will be excluded.
- This procedure will help ensure that those included in the study will show potentiation of physiological reactivity while anticipating exposure to public speaking.
Who cannot join
- Any potentially confounding medical illness
- Lifetime history of any neurological illness or injury including neurodegenerative disorders or dementia, stroke, seizure disorders, neurosurgical procedures, head injury resulting in loss of consciousness for greater than 5 min.
- Lifetime history, diagnosed by DSM-IV criteria (or DSM-5 once its SCID available), of bipolar disorder, schizophrenia or other psychotic disorder, pervasive developmental disorder, chronic mental disorder due to a medical condition or other potentially confounding chronic mental disorder.
- Current major depressive, dysthymic or anxiety disorder other than Social Anxiety Disorder or other potentially confounding current mental disorder diagnosed by DSM-IV criteria (or DSM-5 once its SCID available).
- DSM-IV substance abuse or dependence within the last year, lifetime history of hospitalization for substance abuse (determined at clinical interview) or positive urine toxicology screen at the time of the clinical interview
- Any evidence of suicidal ideation, violent behavior or psychosis at the clinical interview
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- Use of psychiatric medication within 4 weeks of study (with the exception of 6 weeks for fluoxetine)
- Current psychotherapy for Social Anxiety Disorder
- Any indication of a sleep disorder, particularly sleep-disordered breathing, on the Pittsburgh Structured Clinical Interview for Sleep Disorders
- Sleep onset latency > 1 hr, total sleep time < 5 hr or typical bed time later than 3 AM
- Overnight shift work or recent travel across multiple time zones
- > 4 caffeinated beverages per day or > 11 alcoholic beverages per week
- Nicotine use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital, One Bowdoin Square
Boston, Massachusetts, 02114
Massachusetts General Hospital-East, Building 149
Charlestown, Massachusetts, 02129
About this study
Investigators will examine whether post-exposure naps can be used to strengthen therapeutic extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the Liebowitz Social Anxiety Scale, by self-report during a clinical interview and by demonstrated enhanced psychophysiological reactivity when imagining a socially stressful scenario, will be enrolled as one of four participants in one of eight successive offerings of a validated 5-session exposure-based group treatment for extreme social anxiety. The third and fourth sessions conclude with each participant delivering a speech on a topic individually chosen to elicit significant social anxiety. Following these sessions, participants will go to the sleep laboratory where two will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring and two will be similarly instrumented but undergo 2 hours of monitored quiet wakefulness. Before and after treatment, participants will be individually assessed for social anxiety symptoms using standardized self-report instruments and a Trier Social Stress Test (TSST) modified for continuous psychophysiological monitoring. Ambulatory monitoring of home sleep will also be obtained using actigraphy and sleep diaries. The investigators hypothesize that, post treatment, those individuals who napped will show greater questionnaire-based clinical improvement as well as lesser psychophysiological reactivity during the modified TSST compared to those who remained quietly awake. The investigators further hypothesize that characteristics of sleep quality and architecture during naps, specifically durations of total sleep, REM and slow-wave sleep, as well as REM continuity, will predict greater clinical improvement and lesser psychophysiological reactivity to the TSST in those who napped following their third and fourth therapy sessions. Positive results will provide the first proof-of-principle for sleep augmentation of exposure therapy for clinically significant extreme social anxiety.
Read the detailed description
Widely replicated studies demonstrate that sleep can enhance memory consolidation. Potential clinical applications of such findings have only begun to be explored. The investigators have recently shown that nocturnal sleep following simulated exposure therapy for high levels of spider fear reduced both psychophysiological and self-reported reactivity when participants were re-exposed to the same and to novel spider stimuli. The proposed research will extend these findings to the more debilitating and clinically important condition of extreme social anxiety. The investigators will examine whether post-exposure naps can be used to strengthen therapeutic extinction memories formed during exposure exercises used in the behavioral treatment of extreme social anxiety. A total of 32 individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the Liebowitz Social Anxiety Scale, self-report during a clinical interview and demonstrated enhanced psychophysiological reactivity when imagining a socially stressful scenario, will be enrolled in an exposure-based group treatment for extreme social anxiety. Eight successive therapy groups of 4 patients each will be offered during the 2-year funding period. The third and fourth sessions of this validated 5-week/5-session treatment will involve each participant delivering a speech on a topic individually chosen to elicit significant social anxiety. Following both of these sessions, all 4 participants will go to the nearby Massachusetts General Hospital sleep laboratory where 2 will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring and the other 2 will be similarly instrumented but undergo 2 hours of monitored quiet wakefulness (prior to session 3 participants will be randomized to the sleep or wakefulness arm). Before beginning treatment and within several days following the final treatment session, all participants will be individually assessed for social anxiety symptoms using standardized self-report instruments. At these same times, they will undergo a Trier Social Stress Test (TSST) modified for continuous psychophysiological monitoring that also includes repeated Subjective Units of Distress (SUDS) self report and sampling for salivary cortisol. In addition to laboratory PSG, ambulatory monitoring of home sleep with actigraphy and sleep diaries will take place at pre-treatment baseline and during the last 3 weeks of treatment. The investigators hypothesize that those individuals allowed a 2-hour sleep opportunity following exposure sessions, compared to those who remained quietly awake, will show greater questionnaire-based clinical improvement as well as lesser psychophysiological and SUDS reactivity during the modified TSST. The investigators further hypothesize that characteristics of sleep quality and architecture during naps, specifically durations of total sleep, REM sleep and slow-wave sleep as well as REM continuity, will predict clinical improvement and diminished TSST reactivity in those who napped. To help ensure that observed sleep effects are attributable to the two 2-hour sleep opportunities, the investigators will control for actigraph and diary-measured sleep quality during treatment. Positive results will provide the first proof-of-principle for sleep augmentation of exposure therapy for a clinically significant extreme social anxiety.
- Conditions
- Social Anxiety Disorder, Sleep Laboratory
- Being tested
- Sleep-enhancement of extinction memory
- Keywords
- social anxiety, exposure therapy, extinction, sleep-dependent memory consolidation
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep-enhancement of extinction memoryBehavioural
Recent reports show that sleep promotes memory consolidation. The investigators' preliminary findings suggest sleep may enhance the therapeutic extinction memories acquired during exposure therapy. For sleep-enhancement of extinction memory, the current intervention uses post-exposure naps as a means to provide sleep in close temporal proximity to the encoding of memory for the extinction social exposure fears in individuals with severe social anxiety symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Post-Exposure Nap | Experimental | Sleep-enhancement of extinction memory: At the end of the third and fourth of 5 exposure therapy sessions, all participants deliver a speech designed to elicit significant social anxiety. Following this speech, this arm will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring. Receives: Behavioral: Sleep-enhancement of extinction memory |
| Post-Exposure Wake | Active comparator | At the end of the third and fourth of 5 exposure therapy sessions, all participants deliver a speech designed to elicit significant social anxiety. Following this speech, this arm will be instrumented for PSG but, instead of napping, will undergo 2 hours of quiet wakefulness. Therefore, this arm will not undergo sleep-enhancement of extinction memory. Receives: Behavioral: Sleep-enhancement of extinction memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leibowitz Social Anxiety Scale
Validated self-report scale used to assess degree of social anxiety
Measured: 5 weeks
Fear-potentiated startle
Orbicularis oculi electromyography used to record the blink startle response to loud tones while anticipating delivering a speech to an audience and during an initial baseline period; difference measure obtained by subtracting the baseline startle response from the startle response recorded while anticipating a fearful situation
Measured: 5 weeks
Secondary outcomes (9)
Fear of Negative Evaluation Scale
Validated self-report scale to assess fear of negative evaluation by others
Measured: 5 weeks
Social Phobia and Anxiety Inventory
Validated self-report scale to assess degree of social anxiety
Measured: 5 weeks
Clinical Global Impressions Scale
Validated clinician-based evaluation of symptom severity and impairment of functioning
Measured: 5 weeks
Pre- to-post TSST change in Spielberger State-Trait Anxiety Inventory-State portion score
Validated self-report scale to assess an individual's current level of anxiety; administered before and after TSST; pre-post difference indexes degree to which the TSST increased state anxiety
Measured: up to 5 weeks
Subjective Units of Distress Ratings
Validated, individually anchored, rating of subjective distress on a scale of 0 to 100
Measured: 5 weeks
Pre- to-post TSST change in salivary cortisol
Salimetrics oral swab used to collect and analyze salivary cortisol levels at baseline and at time points reflective of maximum levels evoked by the speech-performance phase of the TSST.
Measured: up to 5 weeks
Fear potentiation of loud-tone evoked heart-rate acceleration (HRA) and skin conductance response (SCR)
Electrocardiography records HRA and electrodermal measures record SCR evoked by loud tones while anticipating delivering a speech to an audience; responses to same stimuli recorded during an initial baseline period; difference measure obtained by subtracting baseline HRA and SCR from HRA and SCR recorded while anticipating a fearful situation.
Measured: 5 weeks
Increase in baseline heart rate from baseline to performance phases of TSST
Electrocardiography records maximum heart rate during an initial baseline; difference measure subtracts baseline from the maximum heart-rate during actual delivery of the speech in TSST performance phase.
Measured: up to 5 weeks
Increase in mean corrugator supercilii EMG from baseline to performance phases of TSST
Electromyography records mean corrugator supercilii muscle tone during baseline period; difference measure subtracts baseline from the mean corrugator supercilii muscle tone recorded during actual delivery of speech in the TSST performance phase.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Edward F. Pace-Schott, Massachusetts General Hospital
- Investigators
- Edward F Pace-Schott, Ph.D., Principal investigator, Massachusetts General Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325128
- Sponsor's protocol ID
- 2014P001501/MGH
- Acronym
- SANAP
- Status last verified
- Nov 2018
- First submitted
- 19 Dec 2014
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Pace-Schott EF, Verga PW, Bennett TS, Spencer RM. Sleep promotes consolidation and generalization of extinction learning in simulated exposure therapy for spider fear. J Psychiatr Res. 2012 Aug;46(8):1036-44. doi: 10.1016/j.jpsychires.2012.04.015. Epub 2012 May 10.
PubMed 22578824Zalta AK, Dowd S, Rosenfield D, Smits JA, Otto MW, Simon NM, Meuret AE, Marques L, Hofmann SG, Pollack MH. Sleep quality predicts treatment outcome in CBT for social anxiety disorder. Depress Anxiety. 2013 Nov;30(11):1114-20. doi: 10.1002/da.22170. Epub 2013 Aug 26.
PubMed 24038728Pace-Schott EF, Bottary RM, Kim SY, Rosencrans PL, Vijayakumar S, Orr SP, Lasko NB, Goetter EM, Baker AW, Bianchi MT, Gannon K, Hoeppner SS, Hofmann SG, Simon NM. Effects of post-exposure naps on exposure therapy for social anxiety. Psychiatry Res. 2018 Dec;270:523-530. doi: 10.1016/j.psychres.2018.10.015. Epub 2018 Oct 9.
PubMed 30340182
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Exposure Therapy for High Levels of Social Anxiety Using Post-exposure Naps
- ClinicalTrials.gov ID
- NCT02325128
- Acronym / sponsor ID
- SANAP / 2014P001501/MGH
- Conditions
- Social Anxiety Disorder, Sleep Laboratory
- Keywords
- social anxiety, exposure therapy, extinction, sleep-dependent memory consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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.
Investigators will examine whether post-exposure naps can be used to strengthen therapeutic extinction memories formed during exposure therapy for extreme social anxiety. Thirty-two individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the Liebowitz Social Anxiety Scale, by self-report during a clinical interview and by demonstrated enhanced psychophysiological reactivity when imagining a socially stressful scenario, will be enrolled as one of four participants in one of eight successive offerings of a validated 5-session exposure-based group treatment for extreme social anxiety. The third and fourth sessions conclude with each participant delivering a speech on a topic individually chosen to elicit significant social anxiety. Following these sessions, participants will go to the sleep laboratory where two will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring and two will be similarly instrumented but undergo 2 hours of monitored quiet wakefulness. Before and after treatment, participants will be individually assessed for social anxiety symptoms using standardized self-report instruments and a Trier Social Stress Test (TSST) modified for continuous psychophysiological monitoring. Ambulatory monitoring of home sleep will also be obtained using actigraphy and sleep diaries. The investigators hypothesize that, post treatment, those individuals who napped will show greater questionnaire-based clinical improvement as well as lesser psychophysiological reactivity during the modified TSST compared to those who remained quietly awake. The investigators further hypothesize that characteristics of sleep quality and architecture during naps, specifically durations of total sleep, REM and slow-wave sleep, as well as REM continuity, will predict greater clinical improvement and lesser psychophysiological reactivity to the TSST in those who napped following their third and fourth therapy sessions. Positive results will provide the first proof-of-principle for sleep augmentation of exposure therapy for clinically significant extreme social anxiety.
Detailed description
Widely replicated studies demonstrate that sleep can enhance memory consolidation. Potential clinical applications of such findings have only begun to be explored. The investigators have recently shown that nocturnal sleep following simulated exposure therapy for high levels of spider fear reduced both psychophysiological and self-reported reactivity when participants were re-exposed to the same and to novel spider stimuli. The proposed research will extend these findings to the more debilitating and clinically important condition of extreme social anxiety. The investigators will examine whether post-exposure naps can be used to strengthen therapeutic extinction memories formed during exposure exercises used in the behavioral treatment of extreme social anxiety. A total of 32 individuals with high levels of social anxiety, evidenced by scores of 60 or greater on the Liebowitz Social Anxiety Scale, self-report during a clinical interview and demonstrated enhanced psychophysiological reactivity when imagining a socially stressful scenario, will be enrolled in an exposure-based group treatment for extreme social anxiety. Eight successive therapy groups of 4 patients each will be offered during the 2-year funding period. The third and fourth sessions of this validated 5-week/5-session treatment will involve each participant delivering a speech on a topic individually chosen to elicit significant social anxiety. Following both of these sessions, all 4 participants will go to the nearby Massachusetts General Hospital sleep laboratory where 2 will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring and the other 2 will be similarly instrumented but undergo 2 hours of monitored quiet wakefulness (prior to session 3 participants will be randomized to the sleep or wakefulness arm). Before beginning treatment and within several days following the final treatment session, all participants will be individually assessed for social anxiety symptoms using standardized self-report instruments. At these same times, they will undergo a Trier Social Stress Test (TSST) modified for continuous psychophysiological monitoring that also includes repeated Subjective Units of Distress (SUDS) self report and sampling for salivary cortisol. In addition to laboratory PSG, ambulatory monitoring of home sleep with actigraphy and sleep diaries will take place at pre-treatment baseline and during the last 3 weeks of treatment. The investigators hypothesize that those individuals allowed a 2-hour sleep opportunity following exposure sessions, compared to those who remained quietly awake, will show greater questionnaire-based clinical improvement as well as lesser psychophysiological and SUDS reactivity during the modified TSST. The investigators further hypothesize that characteristics of sleep quality and architecture during naps, specifically durations of total sleep, REM sleep and slow-wave sleep as well as REM continuity, will predict clinical improvement and diminished TSST reactivity in those who napped. To help ensure that observed sleep effects are attributable to the two 2-hour sleep opportunities, the investigators will control for actigraph and diary-measured sleep quality during treatment. Positive results will provide the first proof-of-principle for sleep augmentation of exposure therapy for a clinically significant extreme social anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Exposure Nap | Experimental | Behavioral: Sleep-enhancement of extinction memorySleep-enhancement of extinction memory: At the end of the third and fourth of 5 exposure therapy sessions, all participants deliver a speech designed to elicit significant social anxiety. Following this speech, this arm will be given a 2-hour sleep opportunity with polysomnographic (PSG) monitoring. |
| Post-Exposure Wake | Active comparator | Behavioral: Sleep-enhancement of extinction memoryAt the end of the third and fourth of 5 exposure therapy sessions, all participants deliver a speech designed to elicit significant social anxiety. Following this speech, this arm will be instrumented for PSG but, instead of napping, will undergo 2 hours of quiet wakefulness. Therefore, this arm will not undergo sleep-enhancement of extinction memory. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Treatment-seeking individuals diagnosed with Social Anxiety Disorder using the Structured Clinical Interview for DSM-IV56 (DSM-5 SCID once available)
- A score > 60 on the Liebowitz Social Anxiety Scale (LSAS)13
- 18-40 years of age
- Proficient in English
- Normal or corrected to normal vision
Key exclusion criteria (13 listed)
- Any potentially confounding medical illness
- Lifetime history of any neurological illness or injury including neurodegenerative disorders or dementia, stroke, seizure disorders, neurosurgical procedures, head injury resulting in loss of consciousness for greater than 5 min.
- Lifetime history, diagnosed by DSM-IV criteria (or DSM-5 once its SCID available), of bipolar disorder, schizophrenia or other psychotic disorder, pervasive developmental disorder, chronic mental disorder due to a medical condition or other potentially confounding chronic mental disorder.
- Current major depressive, dysthymic or anxiety disorder other than Social Anxiety Disorder or other potentially confounding current mental disorder diagnosed by DSM-IV criteria (or DSM-5 once its SCID available).
- DSM-IV substance abuse or dependence within the last year, lifetime history of hospitalization for substance abuse (determined at clinical interview) or positive urine toxicology screen at the time of the clinical interview
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 |
|---|---|---|
| Sleep-enhancement of extinction memoryRecent reports show that sleep promotes memory consolidation. The investigators' preliminary findings suggest sleep may enhance the therapeutic extinction memories acquired during exposure therapy. For sleep-enhancement of extinction memory, the current intervention uses post-exposure naps as a means to provide sleep in close temporal proximity to the encoding of memory for the extinction social exposure fears in individuals with severe social anxiety symptoms. | Behavioural | Post-Exposure Nap, Post-Exposure Wake |
Primary outcome
Leibowitz Social Anxiety Scale
Time frame: 5 weeks
Validated self-report scale used to assess degree of social anxiety
Fear-potentiated startle
Time frame: 5 weeks
Orbicularis oculi electromyography used to record the blink startle response to loud tones while anticipating delivering a speech to an audience and during an initial baseline period; difference measure obtained by subtracting the baseline startle response from the startle response recorded while anticipating a fearful situation
9 secondary outcomes
Fear of Negative Evaluation Scale
Time frame: 5 weeks
Social Phobia and Anxiety Inventory
Time frame: 5 weeks
Clinical Global Impressions Scale
Time frame: 5 weeks
Pre- to-post TSST change in Spielberger State-Trait Anxiety Inventory-State portion score
Time frame: up to 5 weeks
Subjective Units of Distress Ratings
Time frame: 5 weeks
Pre- to-post TSST change in salivary cortisol
Time frame: up to 5 weeks
Fear potentiation of loud-tone evoked heart-rate acceleration (HRA) and skin conductance response (SCR)
Time frame: 5 weeks
Increase in baseline heart rate from baseline to performance phases of TSST
Time frame: up to 5 weeks
Increase in mean corrugator supercilii EMG from baseline to performance phases of TSST
Time frame: 5 weeks
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 21 Nov 2018.
- Background: PubMed 22578824Pace-Schott EF, Verga PW, Bennett TS, Spencer RM. Sleep promotes consolidation and generalization of extinction learning in simulated exposure therapy for spider fear. J Psychiatr Res. 2012 Aug;46(8):1036-44. doi: 10.1016/j.jpsychires.2012.04.015. Epub 2012 May 10.
- Background: PubMed 24038728Zalta AK, Dowd S, Rosenfield D, Smits JA, Otto MW, Simon NM, Meuret AE, Marques L, Hofmann SG, Pollack MH. Sleep quality predicts treatment outcome in CBT for social anxiety disorder. Depress Anxiety. 2013 Nov;30(11):1114-20. doi: 10.1002/da.22170. Epub 2013 Aug 26.
- Results publication: PubMed 30340182Pace-Schott EF, Bottary RM, Kim SY, Rosencrans PL, Vijayakumar S, Orr SP, Lasko NB, Goetter EM, Baker AW, Bianchi MT, Gannon K, Hoeppner SS, Hofmann SG, Simon NM. Effects of post-exposure naps on exposure therapy for social anxiety. Psychiatry Res. 2018 Dec;270:523-530. doi: 10.1016/j.psychres.2018.10.015. Epub 2018 Oct 9.
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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.
Edward F Pace-Schott, Ph.D. principal investigator
Massachusetts General Hospital and Harvard Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep-enhancement of extinction memory in people with Social Anxiety Disorder and Sleep Laboratory, run by Massachusetts General Hospital at 2 sites in United States.
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 15 inclusion and 13 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Leibowitz Social Anxiety Scale (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325128, which also lists 3 linked publications.
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 21 Nov 2018.