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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01081314 |
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Date of registration:
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03/03/2010 |
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Primary sponsor: |
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Public title:
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Treating PTSD in Patients With Borderline Personality Disorder
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Scientific title:
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Treating PTSD in Patients With Borderline Personality Disorder |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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49 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01081314 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Melanie S Harned, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- Age 18-60
- Meet criteria for borderline personality disorder
- Meet criteria for post-traumatic stress disorder
- Can clearly remember at least some part of the traumatic event(s)
- Recent and recurrent self-injurious behavior
- Lives within commuting distance of University of Washington, Seattle campus
- Consents to all research protocols
Exclusion Criteria:
- Male
- Court ordered to treatment
- Diagnosis of psychotic disorder, bipolar disorder, or seizure disorder requiring
medication
- Less than 18 years of age or older than 60 years of age
- Problems which by their presence or severity preclude ability to attend or understand
treatment and/or requires priority treatment
- Familial or domestic relationship with a current study participant
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Borderline Personality Disorder
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Self-Injurious Behavior
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Stress Disorders, Post-Traumatic
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Suicide
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Intervention(s)
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Behavioral: Dialectical Behavior Therapy
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Behavioral: PTSD Protocol
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Primary Outcome(s)
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PTSD Symptom Scale - Interview
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Suicide Attempt Self-Injury Interview
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Secondary Outcome(s)
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Dissociative Experiences Scale
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Hamilton Rating Scale for Depression
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Suicidal Behaviors Questionnaire
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Treatment History Interview
[Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months]
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Secondary ID(s)
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36517-C
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R34MH082143
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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