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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00145678
Other study ID # SUNY UMU IRB 4968
Secondary ID 130230-44
Status Completed
Phase Phase 2
First received September 1, 2005
Last updated January 5, 2015
Start date June 2004
Est. completion date May 2010

Study information

Verified date January 2015
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age between 18 and 45 years

- Meets diagnostic criteria for borderline personality disorder and for active alcohol abuse or dependence

- At least average intelligence

Exclusion Criteria:

- Meets diagnostic criteria for schizophrenia, or schizoaffective disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.
Optimized Community Care
individual and group psychotherapy in a private practice, clinic, and/or rehab setting, with an eclectic orientation

Locations

Country Name City State
United States SUNY Upstate Medical University, University Hospital Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gregory RJ. Borderline attributions. Am J Psychother. 2007;61(2):131-47. — View Citation

Gregory RJ. The deconstructive experience. Am J Psychother. 2005;59(4):295-305. — View Citation

Gregory RJ. Thematic stages of recovery in the treatment of borderline personality disorder. Am J Psychother. 2004;58(3):335-48. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary episodes of parasuicide, alcohol intoxication, institutional care 12 months Yes
Secondary depression, dissociation, core symptoms of borderline pd, perceived social support 12 months No
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