Amendment 1 ( ): Extension of primary outcome measure (Acrophobia Questionnaire) by 6-month follow-up

Transcription

1 Trial Description Title Height anxiety study Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language The purpose of the study is to examine factors underlying exposure therapy in virtual reality. Exposure therapy is a form of cognitive behavioral therapy, where patients are confronted with their feared object or situation. Participants receive different instructions during exposure therapy. Participants are persons (18-65 years) with acrophobia. Amendment 1 ( ): Extension of primary outcome measure (Acrophobia Questionnaire) by 6-month follow-up Brief Summary in Scientific Language A therapy manual based on Emotional Processing Theory is compared with a manual based on inhibitory learning for exposure therapy for acrophobia. Participants are randomly assigned to one of two active groups and get two sessions of in-virtuo exposure therapy. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 19/14, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg Secondary IDs Page 1 of 5

2 Health condition or Problem studied ICD10: F Specific (isolated) phobias Interventions/Observational Groups Arm 1: <style pdffontname='helvetica-bold' isbold='true'>virtual reality exposure therapy using an inhibitory learning approach [1]. Two sessions of individual therapy using a CAVE system within one week (ca. 45 min per session). [1] Craske, M. G., Treanor, M., Conway, C. C., Zbozinek, T., & Vervliet, B. (2014). Maximizing exposure therapy: an inhibitory learning approach. Behaviour Research and Therapy, 58, </style> Arm 2: <style pdffontname='helvetica-bold' isbold='true'>virtual reality exposure therapy using an habituation based approach based on Emotional Processing Theory [1]. Two sessions of individual therapy using a CAVE system within one week (ca. 45 min per session). [1] Foa, E. B., & Kozak, M. J. (1986). Emotional processing of fear: exposure to corrective information. Psychological Bulletin, 99(1), 20.</style> Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: patient/subject Control: Active control (effective treament of control group) Purpose: Treatment Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Acrophobia Questionnaire, at the beginning and the end of the study (2-3 days after the last exposure session), as well as a 6-month follow-up. Secondary Outcome Page 2 of 5

3 Behavioral Avoidance Test (subjective fear ratings while climbing the staircase of a parking lot), at the beginning and the end of the study (2-3 days after the last exposure session). Countries of recruitment DE Locations of Recruitment other Universität Würzburg, Würzburg Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/09/09 Target Sample Size: 50 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 65 Years Additional Inclusion Criteria Acrophobia; diagnosed specific phobia using the SCID-I Exclusion criteria * Schizophrenia and other psychotic disorders * Major depression * Substance dependence * Cardiovascular disease * Pregnancy * Nausea in 3D movies < 3 (on a 0-10 scale) Addresses Primary Sponsor Page 3 of 5

4 Primary Sponsor [---]* URL: [---]* Contact for Scientific Queries Mr. Daniel Gromer Würzburg Telephone: daniel.gromer at uni-wuerzburg.de URL: Contact for Public Queries Mr. Daniel Gromer Telephone: daniel.gromer at uni-wuerzburg.de URL: Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Page 4 of 5

5 Institutional budget, no external funding (budget of sponsor/pi) [---]* URL: [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5