Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
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ClinicalTrials.gov Identifier: NCT01464892 |
Recruitment Status : Unknown
Verified December 2015 by Mrs. M. Kindt, VU University of Amsterdam.
Recruitment status was: Active, not recruiting
First Posted : November 4, 2011
Last Update Posted : December 21, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | October 25, 2011 | |||
First Posted Date ICMJE | November 4, 2011 | |||
Last Update Posted Date | December 21, 2015 | |||
Study Start Date ICMJE | October 2011 | |||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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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 | Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma | |||
Official Title ICMJE | Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma | |||
Brief Summary | Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Posttraumatic Stress Disorder (PTSD) | |||
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 | |||
Actual Enrollment ICMJE |
61 | |||
Original Estimated Enrollment ICMJE |
90 | |||
Estimated Study Completion Date ICMJE | October 2016 | |||
Estimated Primary Completion Date | June 2016 (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 | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01464892 | |||
Other Study ID Numbers ICMJE | 2009-KP-877 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Mrs. M. Kindt, VU University of Amsterdam | |||
Study Sponsor ICMJE | VU University of Amsterdam | |||
Collaborators ICMJE | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |||
Investigators ICMJE |
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PRS Account | VU University of Amsterdam | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |