Enhancing Exposure Therapy for Post-traumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT01574118 |
Recruitment Status : Unknown
Verified January 2015 by Michael J. Telch, University of Texas at Austin.
Recruitment status was: Recruiting
First Posted : April 10, 2012
Last Update Posted : January 26, 2015
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Sponsor:
University of Texas at Austin
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin
Tracking Information | ||||
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First Submitted Date ICMJE | April 3, 2012 | |||
First Posted Date ICMJE | April 10, 2012 | |||
Last Update Posted Date | January 26, 2015 | |||
Study Start Date ICMJE | April 2012 | |||
Estimated Primary Completion Date | March 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline in PTSD symptom severity [ Time Frame: Weeks 6, 10, 22 ] PTSD Symptom Scale - Interview Version
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Enhancing Exposure Therapy for Post-traumatic Stress Disorder | |||
Official Title ICMJE | Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies | |||
Brief Summary | This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. | |||
Detailed Description | This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Posttraumatic Stress Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
54 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | March 2018 | |||
Estimated Primary Completion Date | March 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01574118 | |||
Other Study ID Numbers ICMJE | 2012-02-0100 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Michael J. Telch, University of Texas at Austin | |||
Study Sponsor ICMJE | University of Texas at Austin | |||
Collaborators ICMJE | University of Pennsylvania | |||
Investigators ICMJE |
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PRS Account | University of Texas at Austin | |||
Verification Date | January 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |