- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018639
Impact of Therapist Change on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving DBT
January 11, 2017 updated by: Carolin Steuwe, Evangelisches Krankenhaus Bielefeld gGmbH
Impact of Therapist Change After Initial Contact and Traumatic Burden on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving Dialectical Behavior Therapy
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay.
Beyond that, changes of therapists were documented.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bielefeld, Germany
- Research Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
For this study, all patients aged from 18 to 65, discharged from our personality disorder inpatient unit between December 2012 and August 2016, and fulfilling three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered (n = 89).
Description
Inclusion Criteria:
- three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC)
Exclusion Criteria:
- inability to contract and consent,
- other severe mental disorders (bipolar disorder, acute psychosis),
- current alcohol,
- illicit or not prescribed drug use,
- simultaneous participation in other treatment studies,
- pregnancy or breastfeeding,
- an inability to negotiate a non-suicide agreement,
- ongoing traumatic contact with the perpetrator, and
- a Body Mass Index < 16.5.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Dialectical Behavior Therapy
The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors.
Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD.
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DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dropout
Time Frame: 10 weeks
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10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Martin Driessen, Research Department, Ev. Krankenhaus Bielefeld
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBT_dropout
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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