Psychodynamic Therapy For Co-Occurring Borderline Personality Disorder and Alcohol Use Disorder
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2005 | ||||
| Last Updated Date | April 11, 2008 | ||||
| Start Date ICMJE | June 2004 | ||||
| Estimated Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
episodes of parasuicide, alcohol intoxication, institutional care [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
episodes of self-injury, self-reported alcohol use, inpatient psychiatry days | ||||
| Change History | Complete list of historical versions of study NCT00145678 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
depression, dissociation, core symptoms of borderline pd, perceived social support [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
depression, dissociation, social and occupational functioning | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Psychodynamic Therapy For Co-Occurring Borderline Personality Disorder and Alcohol Use Disorder | ||||
| Official Title ICMJE | Psychodynamic Therapy for Patients With Borderline Personality Disorder and Alcohol Abuse | ||||
| Brief Summary | The purpose of the study is to determine the feasibility and effectiveness of a modified form of psychodynamic psychotherapy for persons suffering from co-occurring borderline personality disorder and an alcohol use disorder. |
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| Detailed Description | Borderline Personality Disorder (BPD) is a condition that can cause significant distress and increased risk of death. Many persons with BPD also have an alcohol use disorder (AUD) and there is evidence that this can worsen the outcome and course of both disorders. A manual-based form of psychodynamic therapy (PT), labeled dynamic deconstructive psychotherapy, has been developed for particularly challenging patients with BPD, especially those with co-occurring substance use disorders. It aims to remediate specific neurocognitive capacities that are responsible for processing of emotional experiences, and so diminishes symptoms of BPD and promotes the development of a coherent and differentiated self-structure. PT has been shown to be helpful for BPD, but has not been tested for people who have BPD with co-occurring substance use disorders. The proposed study is a randomized controlled trial of PT for persons with BPD and co-occurring AUD that will generate some initial data that can be used to determine the need and feasibility for further outcome studies. Participants are randomized to either a study group receiving weekly PT or to a control group receiving usual care. Enrollment is 15 participants in each group. The study group will receive 12-18 months of PT, with naturalistic follow-up. Outcome measures are administered by a research assistant at enrollment, 3 months, 6 months, 9 months, 12 months, and 30 months. The investigators anticipate that the PT group will show trends towards better retention in treatment and greater reduction in parasuicides, alcohol misuse, and institutional care. If so, this would have important and positive implications for the large group of patients who suffer from BPD and co-occurring AUD. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Psychodynamic Therapy
Dynamic deconstructive psychotherapy is a time-limited (12-18 month) manual-based form of psychodynamic therapy that aims to remediate specific neurocognitive capacities responsible for processing of emotional experiences.
Other Name: Dynamic Deconstructive Psychotherapy |
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| Study Arm (s) | Not Provided | ||||
| Publications * | |||||
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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 | ||||
| Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | May 2008 | ||||
| Estimated Primary Completion Date | May 2008 (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 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00145678 | ||||
| Other Study ID Numbers ICMJE | SUNY UMU IRB 4968, 130230-44 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Robert J. Gregory, Associate Professor of Psychiatry, SUNY Upstate Medical University | ||||
| Study Sponsor ICMJE | State University of New York - Upstate Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | State University of New York - Upstate Medical University | ||||
| Verification Date | April 2008 | ||||
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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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