Augmentation of Exposure Therapy for High Levels of Social Anxiety Using Post-exposure Naps (SANAP)

November 19, 2018 updated by: Edward F. Pace-Schott, Massachusetts General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital, One Bowdoin Square
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital-East, Building 149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion Criteria:

  1. Treatment-seeking individuals diagnosed with Social Anxiety Disorder using the Structured Clinical Interview for DSM-IV56 (DSM-5 SCID once available)
  2. A score > 60 on the Liebowitz Social Anxiety Scale (LSAS)13
  3. 18-40 years of age
  4. Proficient in English
  5. Normal or corrected to normal vision
  6. Able to give informed consent
  7. Willingness and ability to comply with the requirements of the study protocol

  8. 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.

Exclusion Criteria:

  1. Any potentially confounding medical illness
  2. 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.
  3. 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.
  4. 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).
  5. 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
  6. Any evidence of suicidal ideation, violent behavior or psychosis at the clinical interview
  7. Use of psychiatric medication within 4 weeks of study (with the exception of 6 weeks for fluoxetine)
  8. Current psychotherapy for Social Anxiety Disorder
  9. Any indication of a sleep disorder, particularly sleep-disordered breathing, on the Pittsburgh Structured Clinical Interview for Sleep Disorders
  10. Sleep onset latency > 1 hr, total sleep time < 5 hr or typical bed time later than 3 AM
  11. Overnight shift work or recent travel across multiple time zones
  12. > 4 caffeinated beverages per day or > 11 alcoholic beverages per week
  13. Nicotine use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Post-Exposure Nap
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.
Behavioral: Sleep-enhancement of extinction memory
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.
Active Comparator: Post-Exposure Wake
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.
Behavioral: Sleep-enhancement of extinction memory
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Leibowitz Social Anxiety Scale
Time Frame: 5 weeks
Validated self-report scale used to assess degree of social anxiety
5 weeks
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
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fear of Negative Evaluation Scale
Time Frame: 5 weeks
Validated self-report scale to assess fear of negative evaluation by others
5 weeks
Social Phobia and Anxiety Inventory
Time Frame: 5 weeks
Validated self-report scale to assess degree of social anxiety
5 weeks
Clinical Global Impressions Scale
Time Frame: 5 weeks
Validated clinician-based evaluation of symptom severity and impairment of functioning
5 weeks
Pre- to-post TSST change in Spielberger State-Trait Anxiety Inventory-State portion score
Time Frame: up to 5 weeks
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
up to 5 weeks
Subjective Units of Distress Ratings
Time Frame: 5 weeks
Validated, individually anchored, rating of subjective distress on a scale of 0 to 100
5 weeks
Pre- to-post TSST change in salivary cortisol
Time Frame: up to 5 weeks
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.
up to 5 weeks
Fear potentiation of loud-tone evoked heart-rate acceleration (HRA) and skin conductance response (SCR)
Time Frame: 5 weeks
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.
5 weeks
Increase in baseline heart rate from baseline to performance phases of TSST
Time Frame: up to 5 weeks
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.
up to 5 weeks
Increase in mean corrugator supercilii EMG from baseline to performance phases of TSST
Time Frame: 5 weeks
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.
5 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NEO-PI-R Neuroticism and Extraversion total scores
Time Frame: 5 weeks
Validated and widely used scale to quantify dimensions of personality hypothesized by the 5-factor model; only Neuroticism and Extraversion factors evaluated
5 weeks
Social Avoidance and Distress Scale
Time Frame: 5 weeks
Validated scale used to assess the degree of avoidance of social situations
5 weeks
Social Probability and Social Cost Questionnaire
Time Frame: 5 weeks
Validated instrument to assess degree to which an individual anticipates the likelihood and severity of harm resulting from social encounters
5 weeks
Pre- to-post TSST change in Positive and Negative Affect Scale subtotals
Time Frame: up to 5 weeks
Validated self-report scale to assess participants' current level of positive and negative emotions; administered before and after the TSST; pre-post differences index degree to which the TSST decreased levels of positive emotion and increased levels of negative emotion
up to 5 weeks
Pre- to-post TSST change in Stanford Sleepiness Scale subtotals
Time Frame: up to 5 weeks
Validated self-report scale to assess current level of sleepiness; administered before and after the TSST; pre-post differences index the degree to which the TSST increased subjective arousal (inverse of self-reported sleepiness)
up to 5 weeks
Rate and number of spontaneous SCRs during baseline, preparation and performance phases of TSST
Time Frame: 5 weeks
SCR measures sympathetic nervous system (SNS) activation. Spontaneous SCRs index the degree to which the SNS is phasically activated. A difference measure is obtained between the rate of spontaneous SCRs during baseline phase and rate during the speech preparation and performance phases of the TSST.
5 weeks
Rate of mean HR decline from performance to late recovery phases of the TSST
Time Frame: 5 weeks
Decline in HR from an anticipated maximum during actual performance of the speech until the end of both recovery phases (early and late) following speech; indexes degree to which participant able to self-soothe following stressor
5 weeks
Social Interaction Self-Statements Test
Time Frame: 5 weeks
Self-report test to assess participants' self evaluation following a specific social encounter given at the end of both TSSTs.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward F Pace-Schott, Ph.D., Massachusetts General Hospital and Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P001501/MGH

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