- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247234
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
September 20, 2017 updated by: Norwegian University of Science and Technology
Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
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
-
-
-
Trondheim, Norway, 7030
- St. Olavs Hospital
-
-
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
16 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Avoidant or Borderline personality disorders
Exclusion Criteria:
- Do not speak Scandinavian languages
- Antisocial personality disorder
- Narcissistic personality disorder
- Affective bipolar disorder I
- Schizophrenia
- Mental impairment/organic brain disorder
- Substance dependence
- Planned pregnancy
- Serious somatic illness
- Anorexia Nervosa
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: schema therapy
|
group based schema therapy
|
|
Active Comparator: standard care
standard psychiatric out-patient care
|
standard psychiatric out-patient care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: 5 years
|
Self-report measures
|
5 years
|
|
depression
Time Frame: 5 years
|
Self-report measures
|
5 years
|
|
anxiety
Time Frame: 5 years
|
Self-report measures
|
5 years
|
|
suicidal ideation
Time Frame: 5 years
|
Self-report measures
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of psychotropic medication
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Are Holen, M.D., Ph.D., Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway
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 (Actual)
September 1, 2004
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
October 31, 2005
First Submitted That Met QC Criteria
October 31, 2005
First Posted (Estimate)
November 1, 2005
Study Record Updates
Last Update Posted (Actual)
September 25, 2017
Last Update Submitted That Met QC Criteria
September 20, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ursula.falkmer+AEA-stolav.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
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.