Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder, Randomized Controlled Trial
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group Schema therapy
Individual Schema therapy
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
- DSM-5 criteria for borderline personality disorder
- Aged 18 to 65 years
Exclusion Criteria:
- Psychotic disorders (except short, reactive psychotic episodes)
- Bipolar disorder (current hypo-manic or mixed episode)
- Antisocial personality disorder
- Substance intoxication
- Mental retardation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combined individual + group Schema therapy
Only group Schema therapy
Arm Description
Those who will receive both individual plus group schema therapy
Those who will receive group schema therapy
Outcomes
Primary Outcome Measures
BPD (borderline personality disorder) symptomatology
Severity of borderline symptomatology as measured by a single score from the BSL-23 scale (range: 0-92; the higher the score, the more severe the BPD severity).
Secondary Outcome Measures
global functioning
Severity of dysfunction as measured by a single score from the WHOQoL scale (range: 0-100; the higher the score, the more severe the global dysfunction).
early maladaptive schemas
Severity of maladaptive schemas as measured by a single score from the YSQ scale (range: 0-450; the higher the score, the more severe the EMS severity).
Full Information
NCT ID
NCT04211688
First Posted
December 19, 2019
Last Updated
December 23, 2019
Sponsor
Consorci Sanitari del Maresme
Collaborators
Department of Health, Generalitat de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT04211688
Brief Title
Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
Official Title
Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari del Maresme
Collaborators
Department of Health, Generalitat de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background and Objectives: Schema therapy has been shown to be of benefit in treating borderline personality disorder. However, it is still unclear what the most suitable treatment implementation format is and to what extent therapeutic gains may be generalizable to regular healthcare settings with limited resources.
Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder. Patients were allocated either to a combined (group plus individual) schema therapy format (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder severity was the primary outcome, with other clinical variables considered as secondary outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations. Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited follow-up assessment and the absence of multi-center data that detracted from the long-term stability and generalizability of the findings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined individual + group Schema therapy
Arm Type
Experimental
Arm Description
Those who will receive both individual plus group schema therapy
Arm Title
Only group Schema therapy
Arm Type
Active Comparator
Arm Description
Those who will receive group schema therapy
Intervention Type
Behavioral
Intervention Name(s)
Group Schema therapy
Intervention Description
Bimonthly outpatient psychotherapy delivered in individual setting
Intervention Type
Behavioral
Intervention Name(s)
Individual Schema therapy
Intervention Description
weekly outpatient psychotherapy delivered in group setting
Primary Outcome Measure Information:
Title
BPD (borderline personality disorder) symptomatology
Description
Severity of borderline symptomatology as measured by a single score from the BSL-23 scale (range: 0-92; the higher the score, the more severe the BPD severity).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
global functioning
Description
Severity of dysfunction as measured by a single score from the WHOQoL scale (range: 0-100; the higher the score, the more severe the global dysfunction).
Time Frame
18 months
Title
early maladaptive schemas
Description
Severity of maladaptive schemas as measured by a single score from the YSQ scale (range: 0-450; the higher the score, the more severe the EMS severity).
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-5 criteria for borderline personality disorder
Aged 18 to 65 years
Exclusion Criteria:
Psychotic disorders (except short, reactive psychotic episodes)
Bipolar disorder (current hypo-manic or mixed episode)
Antisocial personality disorder
Substance intoxication
Mental retardation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19807718
Citation
Zanarini MC. Psychotherapy of borderline personality disorder. Acta Psychiatr Scand. 2009 Nov;120(5):373-7. doi: 10.1111/j.1600-0447.2009.01448.x.
Results Reference
result
Citation
Farrell, J. M., & Shaw, I. A. (2012). Group schema therapy for borderline personality disorder. A step-by-step treatment manual with patient workbook. West Sussex, UK: Wiley-Blackwell.
Results Reference
result
Learn more about this trial
Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
We'll reach out to this number within 24 hrs