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Trials / Completed

CompletedNCT02325128

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep-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.

Timeline

Start date
2015-01-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2014-12-24
Last updated
2018-11-21

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02325128. Inclusion in this directory is not an endorsement.