Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Post-traumatic Stress Disorder
This study is ongoing, but not recruiting participants.
Sponsor:
University of Mississippi Medical Center
Collaborator:
Information provided by (Responsible Party):
Scott F. coffey, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01409707
First received: August 2, 2011
Last updated: April 5, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 2, 2011 | ||||
| Last Updated Date | April 5, 2012 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | January 2012 (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 | Complete list of historical versions of study NCT01409707 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Post-traumatic Stress Disorder | ||||
| Official Title ICMJE | Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD | ||||
| Brief Summary | The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients meeting criteria for alcohol dependence and PTSD seeking treatment at a local residential treatment facility. |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Prolonged exposure
cognitive behavioral therapy for PTSD |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Estimated Completion Date | May 2013 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01409707 | ||||
| Other Study ID Numbers ICMJE | 2007-0071, R01AA016816 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Scott F. coffey, University of Mississippi Medical Center | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Mississippi Medical Center | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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