D-Cycloserine and Virtual Reality Exposure Therapy

• Status: Withdrawn
• Trial end date: 2016-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgia State University
• Collaborator: Emory University
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• Understand and provide written informed consent prior to conduct of any study procedures.

• Be able to communicate in English with study personnel

• Be able to manipulate the computer interface to interact with the program

• If female, must have a negative pregnancy test prior to treatment and be maintained on an acceptable method of birth control during treatment

• If using psychotropic medication, stable on medication and dosage for 3 months

Exclusion Criteria:

• Participation in clinical trial within the past 12 months or treatment with DCS in a previous study

• History of mania, schizophrenia, or other psychoses

• Any unstable medical condition; Seizure disorders, with the exception of a childhood history of isolated, non-recurrent febrile seizures

• Current or past substance (except nicotine, caffeine) or alcohol dependence based on DSM-V criteria within six months prior to screening

• Liebowitz Social Anxiety Scale (LSAS) score of < 50 at baseline