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

Completed · Not applicable

Conditions studied: Social Anxiety Disorder, Sleep Laboratory

In brief

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.

Key facts

Study ID

NCT02325128

Run by

Massachusetts General Hospital

People needed

35

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• 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
• 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.

You may not qualify if…

• 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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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