search
Back to results

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
Consorci Sanitari del Maresme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 19, 2019
    Last Updated
    December 23, 2019
    Sponsor
    Consorci Sanitari del Maresme
    Collaborators
    Department of Health, Generalitat de Catalunya
    search

    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