- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123198
Dialectical Behavior Therapy Rutgers University Research Program (DBT-RU)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shireen L Rizvi
- Phone Number: 848-445-3914
- Email: slrizvi@gsapp.rutgers.edu
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Rutgers University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
A. Age 18 years or older. B. Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel.
C. Agreement to pay for mental health services at the DBT-RU, and to participate in research assessments as volunteers.
D. Residence within commuting distance of clinic (< 45 minutes) E. Agreement to discontinue other forms of therapy F. Meets criteria for borderline personality disorder (BPD)
Exclusion Criteria:
- A. Clients who need mental health services not available at the DBT-RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended.
B. Non-English speaking. C. Present DSM-IV diagnosis of Mental Retardation. D. Unable to understand research consent forms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dialectical Behavior Therapy
All participants receive six months of standard DBT which includes individual therapy, skills training, and as-needed phone consultation.
|
DBT is a multimodal comprehensive psychosocial treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Injurious Thoughts and Behaviors Interview
Time Frame: Past six months
|
Interview to assess prevalence rates of suicidal and self-injurious thoughts and behaviors
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Past six months
|
Structured Clinical Interview for DSM-5
Time Frame: At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed.
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Interview to assess lifetime and current rates of psychological disorders
|
At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difficulties in Emotion Regulation Scale
Time Frame: Past two weeks
|
Past two weeks
|
Borderline Symptom List (BSL-23)
Time Frame: Past 1 month
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Past 1 month
|
Brief Symptom Inventory (BSI)
Time Frame: Past 1 week
|
Past 1 week
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2019001864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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