D-Cycloserine and Virtual Reality Exposure Therapy



Status:Withdrawn
Conditions:Anxiety, Healthy Studies
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 1, 2015
End Date:December 31, 2016

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D-Cycloserine and Virtual Reality Exposure Therapy Delivered on an iPad: Increasing Access to Treatment for Social Anxiety Disorder

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.

Social Anxiety Disorder (social phobia) is the most common psychiatric disorder in the US. It
negatively impacts health-related quality of life, educational and economic achievement, and
it leads to attempted suicide in as many as 21% of affected individuals. A critical barrier
to progress in reducing the negative impact of this disorder is that 75-92% of sufferers do
not receive treatment. Social phobia self-help programs delivered via computer are designed
to increase access to treatment and can be effective. Compliance and completion rates of such
programs are, however, quite poor, greatly limiting their impact and accessibility.
Furthermore, self-help programs for social phobia do not directly administer a critical
component of treatment - exposure therapy. The direct administration of self-guided exposure
therapy, using virtual reality is an innovation that would increase the accessibility and
impact of computer delivered treatment.

Exposure therapy is based on well-researched fear extinction learning paradigms, where
individuals confront what they fear in a therapeutic manner and learn that the feared outcome
will not occur. Ressler et al's groundbreaking translational research showed that
D-cycolserine (DCS), an analogue of D-alanine and a partial agonist at the NMDA receptor,
facilitates the process of fear extinction. DCS is different from other pharmacological
agents used to treat social phobia which are prescribed chronically (daily) over a period of
months or years to maintain a therapeutic dose; one pill of DCS is taken immediately before
exposure therapy sessions. This work sparked a flurry of research showing that DCS augments
exposure therapy for a variety of anxiety disorders; people who take DCS show benefit from
therapist-assisted exposure therapy more quickly than those who take placebo. Two randomized
double-blind, placebo-controlled studies of social phobia conclude that the combination of
DCS and therapist-assisted exposure therapy improves treatment response when participants
complete fewer exposure sessions. The ability of DCS to speed up the response to exposure
therapy is especially valuable for sufferers using self-guided treatment, because they are
not generally compliant with the full exposure protocol. The combination of DCS and
self-guided exposure therapy would increase access to effective treatment. The use of DCS
with self-guided exposure, however, has never been tested.

Specific Aims

1. Adapt an existing computer program to deliver self-guided VRE for social phobia via
iPad, and

2. Test the comparative efficacy of DCS vs placebo plus self-guided VRE.

Hypothesis: Participants who receive self-guided VRE plus DCS will show less self-reported
social anxiety and less avoidance during a laboratory based behavioral test following a
5-week intervention than those who received self-guided VRE plus placebo.

The investigators seek to shift current clinical practice in the treatment of social phobia
so that more people with the disorder receive exposure therapy. The investigators will
improve access to evidence-based treatment for social phobia with delivery of exposure via a
computer - a modality that capitalizes on the fact that people with severe social phobia
spend extensive hours on the computer; exposure therapy can come to people with social phobia
"where they are." The investigators also will be the first to test the delivery of exposure
therapy on an iPad. The study design improves the approach of existing research on
computer-delivered programs for social phobia by testing how treatment affects real behavior
- existing research has relied exclusively on self-report measures and assessment of
diagnostic status. No studies have assessed actual behavior - either in the lab or in the
real-world. This study will improve scientific knowledge by answering the question of whether
or not DCS augments self-guided exposure therapy. The combination of a self-help program with
DCS addresses many of the obstacles to treatment with therapist-guided exposure therapy. For
example, there are not enough mental health providers trained in exposure therapy.
Furthermore, social anxiety disorder is characterized by the fear and avoidance of social
situations, and psychotherapy is inherently a social encounter. The effective combination of
DCS and self-guided virtual reality exposure is an avenue for treatment to any sufferer with
access to a computer and a prescribing physician. When the proposed aims are achieved, an
innovative treatment will exist that did not before - self-guided VRE delivered via computer.

The investigators have developed and tested a self-help program delivered via computer, with
minimal therapist support. The self-help program was tested in a small (N=10) uncontrolled
trial of 8 sessions, and results showed decreases in scores on standardized self-report
measures of social anxiety from pre- to post-treatment and follow-up. Large effect sizes were
observed at post-treatment (d = 1.22-1.53) and follow-up (d = 1.41 - 2.39).

Using standardized measures of software usability, participants described the program as
easy-to-use, including a participant who had never before used a computer. Since this study,
the program has been updated with new virtual environments, as well as shortening the
treatment down. The proposed project will adapt an existing program for delivery via a tablet
and to collect data via the computer.

Finally, the investigative team completed a double-blind, placebo controlled trial that
tested the combination of DCS vs placebo combined with therapist-guided VRE for specific
phobia.

Thus, the investigative team is well-positioned to complete the specific aims of adapting a
computer program that delivers self-guided exposure therapy for social phobia via a tablet
and testing following hypothesis: Participants who receive self-guided exposure therapy plus
DCS will show less self-reported social anxiety and less avoidance during a laboratory based
behavioral test following a 5-week intervention than those who received self-guided exposure
therapy plus placebo.

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
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