Borderline Personality DisorderPhase 2NCT00145678
Psychodynamic Therapy For Co-occurring Borderline Personality Disorder and Alcohol Use Disorder
A Phase 2 study testing Psychodynamic Therapy and Optimized Community Care in people with Borderline Personality Disorder and Alcohol Use Disorder, run by State University of New York - Upstate Medical University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Alcohol Use Disorder
- What is being tested?
- Psychodynamic Therapy and Optimized Community Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years
- Meets diagnostic criteria for borderline personality disorder and for active alcohol abuse or dependence
- At least average intelligence
Who cannot join
- Meets diagnostic criteria for schizophrenia, or schizoaffective disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University, University Hospital
Syracuse, New York, 13210
About this study
Official title: Psychodynamic Therapy for Patients With Borderline Personality Disorder and Alcohol Abuse
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.
Read the 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.
- Being tested
- Psychodynamic Therapy, Optimized Community Care
- Keywords
- borderline, alcohol, substance, psychodynamic, psychotherapy, psychoanalytic
- Medical subject headings
- Borderline Personality Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodynamic TherapyBehavioural
Also called Dynamic Deconstructive Psychotherapy
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 CareBehavioural
Also called Treatment as Usual
individual and group psychotherapy in a private practice, clinic, and/or rehab setting, with an eclectic orientation
| Study group | Role | What they receive |
|---|---|---|
| dynamic deconstructive psychotherapy | Experimental | weekly individual psychotherapy of 50 minute duration lasting 12-18 months Receives: Behavioral: Psychodynamic Therapy |
| optimized community care | Active comparator | eclectic weekly individual and group psychotherapy, as well as drug and alcohol rehabilitation Receives: Behavioral: Optimized Community Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
episodes of parasuicide, alcohol intoxication, institutional care
Measured: 12 months
Secondary outcomes (1)
depression, dissociation, core symptoms of borderline pd, perceived social support
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J. Gregory, M.D., Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145678
- Sponsor's protocol ID
- SUNY UMU IRB 4968
- Other IDs
- 130230-44
- Status last verified
- Jan 2015
- First submitted
- 1 Sep 2005
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gregory RJ. Thematic stages of recovery in the treatment of borderline personality disorder. Am J Psychother. 2004;58(3):335-48. doi: 10.1176/appi.psychotherapy.2004.58.3.335.
PubMed 15675256Gregory RJ. Borderline attributions. Am J Psychother. 2007;61(2):131-47. doi: 10.1176/appi.psychotherapy.2007.61.2.131.
PubMed 17760318Gregory RJ. The deconstructive experience. Am J Psychother. 2005;59(4):295-305. doi: 10.1176/appi.psychotherapy.2005.59.4.295.
PubMed 16555459Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychodynamic Therapy for Patients With Borderline Personality Disorder and Alcohol Abuse
- ClinicalTrials.gov ID
- NCT00145678
- Acronym / sponsor ID
- SUNY UMU IRB 4968
- Keywords
- borderline, alcohol, substance, psychodynamic, psychotherapy, psychoanalytic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic deconstructive psychotherapy | Experimental | Behavioral: Psychodynamic Therapyweekly individual psychotherapy of 50 minute duration lasting 12-18 months |
| optimized community care | Active comparator | Behavioral: Optimized Community Careeclectic weekly individual and group psychotherapy, as well as drug and alcohol rehabilitation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years
- Meets diagnostic criteria for borderline personality disorder and for active alcohol abuse or dependence
- At least average intelligence
Key exclusion criteria (1 listed)
- Meets diagnostic criteria for schizophrenia, or schizoaffective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychodynamic TherapyAlso: Dynamic Deconstructive PsychotherapyDynamic 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. | Behavioural | dynamic deconstructive psychotherapy |
| Optimized Community CareAlso: Treatment as Usualindividual and group psychotherapy in a private practice, clinic, and/or rehab setting, with an eclectic orientation | Behavioural | optimized community care |
Primary outcome
episodes of parasuicide, alcohol intoxication, institutional care
Time frame: 12 months
1 secondary outcome
depression, dissociation, core symptoms of borderline pd, perceived social support
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Background: PubMed 15675256Gregory RJ. Thematic stages of recovery in the treatment of borderline personality disorder. Am J Psychother. 2004;58(3):335-48. doi: 10.1176/appi.psychotherapy.2004.58.3.335.
- Background: PubMed 17760318Gregory RJ. Borderline attributions. Am J Psychother. 2007;61(2):131-47. doi: 10.1176/appi.psychotherapy.2007.61.2.131.
- Background: PubMed 16555459Gregory RJ. The deconstructive experience. Am J Psychother. 2005;59(4):295-305. doi: 10.1176/appi.psychotherapy.2005.59.4.295.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Gregory, M.D. principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychodynamic Therapy and Optimized Community Care in people with Borderline Personality Disorder and Alcohol Use Disorder, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
episodes of parasuicide, alcohol intoxication, institutional care (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145678, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.