Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06132425 |
Other study ID # |
IRB#23-000236 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 18, 2023 |
Est. completion date |
December 12, 2023 |
Study information
Verified date |
June 2024 |
Source |
University of California, Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to 1) examine the importance of self-reported relief following
exposure and 2) test whether positive-focused rehearsal following exposure can improve
treatment outcomes for participants who endorse fear of public speaking.
Exposure therapy is an extinction-based behavioral technique, often employed in the context
of cognitive behavioral therapy. It involves strategically exposing an individual to a feared
stimulus in an effort to generate new non-fear associations with that stimulus. Relief refers
to the positive, rewarding emotions associated with the absence of an expected aversive
outcome following exposure to a feared stimulus.
In the current study, participants will engage in a series of short public speaking exposures
that take place over two sessions. After every two exposures, participants will be asked to
complete either a positive or neutral rehearsal exercise, consisting of recalling either
positive or neutral aspects of the speech exposures. At multiple points throughout the study,
participants will complete ratings of reward sensitivity, positive affect, relief, and
expectancy of the aversive outcome.
The investigators will test the following: 1) the relationship of reward sensitivity and
positive affect with relief following exposures, 2) the relationship between relief after
exposure and learning rate (i.e., learning that the feared stimulus does not predict an
aversive outcome), 3) potential differences in exposure outcomes between the positive and
neutral rehearsal groups.
Description:
Treatment response rates for cognitive behavioral therapy (CBT) across anxiety disorders
average approximately 50% post-treatment and at follow-up. Thus, recent research has
amplified efforts toward improving treatment methodology in an attempt to optimize clinical
outcomes. Many efforts have targeted exposure therapy, an evidence-based behavioral technique
during which a participant is strategically and repeatedly exposed to a feared stimulus in
order to generate new non-fear associations with that stimulus.
Mechanisms of exposure therapy have been conceptualized using inhibitory retrieval models of
extinction learning. These models, derived from Pavlovian conditioning, posit that extinction
is dependent upon formation of an inhibitory association where the feared conditional
stimulus (CS) no longer predicts the aversive unconditional stimulus (US). The new inhibitory
CS-noUS association then competes with the original CS-US association. Research has
demonstrated that greater expectation of US occurrence (US expectancy) followed by the
unexpected omission of the US (i.e., expectancy violation) is associated with greater
learning of the inhibitory association. Exposure therapy is a clinical proxy of extinction;
in order to compete with the original association between public speaking (CS) and rejection
(US), participants engage in repeated exposures to the CS without the US (no rejection) and
form a new inhibitory association wherein public speaking no longer predicts rejection.
Strategies to enhance this inhibitory learning process include mental rehearsal, where
information from a previous exposure trial is recounted to reinforce the newly learned
inhibitory association.
There is also promising evidence which suggests that reward processes may facilitate
extinction learning, though studies have yet to be conducted in a clinical sample.
Experimental studies have demonstrated that greater relief, a positive emotion that occurs
following US omission, is associated with greater expectancy violation. This suggests that
positive emotions during exposure (e.g., relief) may directly influence the extinction
learning process. Reduced positive affect has been associated with decreased updating of US
expectancies, leading to slower learning during extinction. In contrast, elevated positive
affect has been associated with enhanced encoding, rehearsal, and retrieval processes, which
may lead to faster learning during extinction and prevent return of fear (i.e., relapse).
Strategies designed to enhance reward sensitivity and positive affect may therefore be an
important avenue of future research to improve exposure therapy outcomes. While not yet
applied during exposure, strategies aimed to increase reward sensitivity via positive-focused
rehearsal have led to decreased anxiety, depression, and negative affect and increased
positive affect. Recent work has shown that rehearsal without a positive focus immediately
following exposure leads to reductions in anxiety. Therefore, rehearsal following exposure
that specifically focuses on positive emotions to increase reward sensitivity has the
potential to lead to even greater symptom improvement.
The current study seeks to examine the role of relief during extinction learning and to test
whether positive-focused rehearsal exercise may be implemented to improve treatment outcomes
in exposure therapy in a population of individuals who demonstrate excessive fear of public
speaking. There are three main goals of the study: 1) examine the relationship of reward
sensitivity and positive affect with relief following exposures, 2) examine the relationship
between relief after exposure and learning rate (i.e., learning that the feared stimulus does
not predict an aversive outcome), and 3) test the efficacy of a positive rehearsal exercise
following exposure compared to a neutral rehearsal exercise.
Participants will engage in a series of short public speaking exposures that take place over
two sessions. After every two exposures, participants will be asked to complete either a
positive or neutral rehearsal exercise, consisting of recalling either positive or neutral
aspects of the speech exposures. At multiple points throughout the study, participants will
complete ratings of reward sensitivity, positive affect, relief, and expectancy of the
aversive outcome.