Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
Primary Purpose
Personality Disorder, Borderline, Avoidant Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Schema Therapy
standard care
Sponsored by
About this trial
This is an interventional treatment trial for Personality Disorder, Borderline
Eligibility Criteria
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
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
schema therapy
standard care
Arm Description
standard psychiatric out-patient care
Outcomes
Primary Outcome Measures
quality of life
Self-report measures
depression
Self-report measures
anxiety
Self-report measures
suicidal ideation
Self-report measures
Secondary Outcome Measures
Use of psychotropic medication
Full Information
NCT ID
NCT00247234
First Posted
October 31, 2005
Last Updated
September 20, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00247234
Brief Title
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
Official Title
Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorder, Borderline, Avoidant Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
schema therapy
Arm Type
Experimental
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
standard psychiatric out-patient care
Intervention Type
Behavioral
Intervention Name(s)
Schema Therapy
Intervention Description
group based schema therapy
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
standard psychiatric out-patient care
Primary Outcome Measure Information:
Title
quality of life
Description
Self-report measures
Time Frame
5 years
Title
depression
Description
Self-report measures
Time Frame
5 years
Title
anxiety
Description
Self-report measures
Time Frame
5 years
Title
suicidal ideation
Description
Self-report measures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Use of psychotropic medication
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Are Holen, M.D., Ph.D.
Organizational Affiliation
Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
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