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D-Cycloserine and Virtual Reality Exposure Therapy

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ClinicalTrials.gov Identifier: NCT02933684
Recruitment Status : Withdrawn (Unable to access components necessary to be able to run the study.)
First Posted : October 14, 2016
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Page Anderson, Georgia State University

Brief 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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Seromycin Behavioral: Virtual Reality Exposure Therapy Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: D-Cycloserine and Virtual Reality Exposure Therapy Delivered on an iPad: Increasing Access to Treatment for Social Anxiety Disorder
Estimated Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: DCS
Participants will receive 50mg of Seromycin (aka D-cycloserine) in conjunction with virtual reality exposure therapy once a week for 4 weeks.
Drug: Seromycin
Seromycin (aka D-cycloserine) is an analogue of D-alanine and a partial agonist at the NMDA receptor, which facilitates the process of fear extinction.
Other Name: D-cycloserine

Behavioral: Virtual Reality Exposure Therapy
Allows for delivery of exposure therapy on an iPad. Participants read a speech to a virtual audience. Exposures become increasingly more difficult as the audience becomes more hostile and speeches increase in length and complexity.

Placebo Comparator: Placebo
Participants will receive a placebo in conjunction with virtual reality exposure therapy once a week for 4 weeks.
Behavioral: Virtual Reality Exposure Therapy
Allows for delivery of exposure therapy on an iPad. Participants read a speech to a virtual audience. Exposures become increasingly more difficult as the audience becomes more hostile and speeches increase in length and complexity.

Drug: Placebo
Administered in pill form.




Primary Outcome Measures :
  1. Change in scores on the Liebowitz Social Anxiety Scale-self report version (LSAS-SR) [ Time Frame: Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit. ]
    Measures fear in and avoidance of 24 social situations.

  2. Change in behavioral avoidance [ Time Frame: Week 1, week 7, and 17 weeks after the first session. ]
    Complete Unstructured Conversation and Impromptu Speech Tasks. The assessments will be video recorded and the amount of eye contact - in seconds - will be rated by blind observers. The number of seconds of eye contact can then be compared across time points.

  3. Change in scores on the Clinical Global Improvement Scale, Patient Report [ Time Frame: Week 7 ]
    Assesses diagnostic remission.


Secondary Outcome Measures :
  1. Change in scores on the Social Phobia Scale [ Time Frame: Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit. ]
    Assesses fears of being scrutinized during performance situations.

  2. Change in scores on the Social Interaction Anxiety Scale [ Time Frame: Participants will complete this measure once a week for 6 weeks and again at 17 weeks after the first visit. ]
    Assesses the cognitive, affective, and behavioral reactions to social interactions.

  3. Change in scores on the Patient Health Questionnaire [ Time Frame: Week 1, week 7. ]
    Assesses depressive symptoms.

  4. Change in scores on the Sheehan Disability Scale [ Time Frame: Week 1, week 7. ]
    Assesses functional impairment across work, social life, and family life.

  5. Change in scores on the Quality of Life Inventory [ Time Frame: Week 1, week 7. ]
    Assesses the degree of satisfaction across important life domains.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933684


Locations
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United States, Georgia
Georgia State University
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Georgia State University
Emory University
Investigators
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Principal Investigator: Page Anderson, PhD Georgia State University
Publications:
Anderson P, Zimand E, Schmertz SK, Ferrer M. Usability and utility of a computerized cognitive-behavioral self-help program for public speaking anxiety. Cognitive and Behavioral Practice 14(2):198-207. 2007.
Beidel DC, Turner SM, Jacob RG, Cooley MR. Assessment of social phobia: Reliability of an impromptu speech task. Journal of Anxiety Disorders 3(3):149-158. 1989.
Deveney CM, McHugh RK, Tolin DF, Pollack MH, Otto MW. Combining D-cycloserine and exposure-based CBT for the anxiety disorders. Clin Neuropsychiatry 6(2):75-82. 2009.

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Responsible Party: Page Anderson, Associate Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT02933684    
Other Study ID Numbers: ULTR000454
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action