D-Cycloserine and Virtual Reality Exposure Therapy
Status:
Withdrawn
Trial end date:
2016-12-31
Target enrollment:
Participant gender:
Summary
The proposed project aims to increase accessibility of exposure therapy, an evidence based
treatment for social anxiety disorder, by adapting a therapist-assisted computer-based
program to be delivered in a self-guided manner on an iPad. A significant problem with
self-guided treatment delivered via computer is compliance. The vast majority of users do not
complete treatment, so achieving therapeutic benefit as quickly as possible is essential.
D-cycloserine is a drug found to augment response to therapist-guided exposure therapy for
anxiety disorders, but has never been tested with self-guided exposure. This study uses a
randomized, double-blind methodology to compare D-cycloserine (50 mg; DCS) to placebo in
combination with self-guided virtual reality exposure therapy (VRE) delivered via iPad to
treat social anxiety disorder. The proposed study tests the hypothesis that patients who
receive DCS in combination with the self-guided VRE will show more improvement than those who
receive placebo in combination with VRE. Outcome measures include self-reported symptoms of
social anxiety, behavioral avoidance, and diagnostic remission. Participants (N=34) are
adults with a primary diagnosis of social anxiety disorder. Participants will complete a
structured diagnostic interview, standardized self-report measures of social anxiety, and a
behavioral avoidance task (i.e., giving a speech) and will be assessed at pre-treatment, at
post-treatment and at 3 month follow-up. Hierarchical linear regression and chi-square
analyses will be used to test differences between those randomized to DCS versus placebo on
the following outcomes: post-treatment scores of self-reported social phobia symptoms,
willingness to and anxiety while giving a speech at post-treatment, and diagnostic remission
at 3 month follow-up. The proposed project combines technological advances with translational
research to develop an innovative and accessible treatment for those with social anxiety
disorder. The pilot data generated from this study will be appealing to a variety of funding
agencies, including the National Institute of Mental Health's call for exploratory clinical
trials of novel interventions for mental illnesses, the Patient-Centered Outcomes Research
Institute's call for effectiveness studies aimed to overcome barriers to treatment, and the
National Science Foundation's call for innovation-technology translation research.