D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
| Tracking Information | |||||
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| First Received Date ICMJE | December 18, 2009 | ||||
| Last Updated Date | March 5, 2012 | ||||
| Start Date ICMJE | July 2009 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV) [ Time Frame: One week post-treatment and 3 months folow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01037101 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Physiological responses to phobia-related stimuli, percentage of steps completed and Subjective Units of Distress during a Behavioral Avoidance Test (BAT) [ Time Frame: One week post-treatment and 3 months follow-up ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights | ||||
| Official Title ICMJE | D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults | ||||
| Brief Summary | The study will determine the effects of D-Cycloserine (DCS) on fear reduction in patients diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET). |
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| Detailed Description | The impact of D-Cycloserine on Virtual Reality Exposure Therapy (VRET) and In Vivo Exposure Therapy (IVET) for phobia of heights (acrophobia) will be tested using a randomized, double-blind, placebo-controlled trial. Eighty participants will be randomly assigned to one of the four treatment conditions: one-session VRET (3 hours) and 50 mg D-Cycloserine (VR-OST + DCS, N1=20); one-session VRET (3 hours) and placebo (VR-OST + Pl, N2=20); one-session IVET (3 hours) and placebo (IV + Pl, N3=20); or one-session IVET (3 hours) and 50 mg D-Cycloserine, (IV + DCS, N4=20). For twenty participants (5 from each group) the treatment will be delayed for three weeks and an additional assessment will be conducted as they will comprise a Wait List (WL) control group. Behavioral, cognitive and physiological changes in acrophobia will be assessed at pre-treatment, post-waitlist, post-treatment and 3 months follow-up. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Height Phobia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01037101 | ||||
| Other Study ID Numbers ICMJE | 07-01-1896 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Crisitian Sirbu, PhD, CAMC Health System | ||||
| Study Sponsor ICMJE | CAMC Health System | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | CAMC Health System | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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