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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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14 January 2013 |
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Main ID: |
NCT00691626 |
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Date of registration:
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02/06/2008 |
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Primary sponsor: |
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Public title:
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Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
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Scientific title:
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CBT for Nightmares in OEF/OIF Veterans |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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115 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00691626 |
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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: 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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Gerlinde C Harb, PhD |
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Address:
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Telephone:
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215-823-5800 |
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Email:
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harb_g@mail.trc.upenn.edu |
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Affiliation:
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Name:
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Gerlinde C Harb, PhD |
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Address:
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Telephone:
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(215) 823-5800 |
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Email:
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harb_g@mail.trc.upenn.edu |
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Affiliation:
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Name:
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Richard Ross, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Medical Center, Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Currently enrolled in treatment in the Philadelphia VA Medical Center or VA
Connecticut Healthcare System Mental Health Clinic
- Meets DSM-IV-R criteria for current PTSD (within the past month)
- Repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6
months)
- A global sleep disturbance, as indicated by a score of five or greater on the
Pittsburgh Sleep Quality Index
- Ability to read and speak English
- A concurrent anxiety disorder or depressive disorder diagnosis will be allowed
- Dementia related to head injury and amnestic disorder related to head injury will be
allowed
Exclusion Criteria:
- Current substance dependence
- Bipolar disorder
- Delirium
- Dementia that is not related to head injury
- Amnestic disorder that is not related to head injury
- Schizophrenia and other psychotic disorders
- Severe traumatic brain injury, as indicated by self-report (loss of consciousness or
alteration of mental status greater than 24 hours, or peri-traumatic memory loss, or
any posttraumatic amnesia greater than 7 days)
- The presence of diagnosed sleep disorders other than insomnia: narcolepsy, circadian
rhythm sleep disorders, and periodic limb movement disorder. Participants in
treatment for sleep apnea, or who have not benefited from or declined available
treatment may be included.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nightmares
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Posttraumatic Stress Disorder
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Sleep Disorders
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Intervention(s)
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Behavioral: CBT for Insomnia plus Imagery Rehearsal
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Behavioral: CBT for Insomnia plus psychoeducation
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Primary Outcome(s)
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Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
[Time Frame: post-treatment, 3 month and 6-month follow-up]
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Secondary Outcome(s)
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Pittsburgh Sleep Quality Index
[Time Frame: post-treatment, 3 month and 6-month follow-up]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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