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Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness
interpersonal effectiveness
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, mindfulness

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Ages between 18 and 45 years
  • BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)

Exclusion Criteria:

  • Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder or mental retardation
  • Participating in any sort of psychotherapy during the study or having participated in dialectical behavioral therapy groups in the past

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mindfulness

    Interpersonal effectiveness

    Arm Description

    As proposed in dialectical behavioral therapy, mindfulness training consist of a set of behavioral skills that aim at improving patient's attentional control and emotional regulation.

    Interpersonal effectiveness skills are focused on improving interpersonal relationships and enhancing patient's ability to display social effective behavior.

    Outcomes

    Primary Outcome Measures

    change from baseline in borderline symptoms after a 10 week intervention
    participants were assessed pre and post interventions

    Secondary Outcome Measures

    change from baseline in decentering after a 10 week intervention
    participants were assessed pre and post interventions
    change from baseline in mindfulness facets after a 10 week intervention
    participants were assessed pre and post interventions
    change from baseline in social interactions after a 10 week intervention
    participants were assessed pre and post interventions

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    March 23, 2015
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02397031
    Brief Title
    Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
    Official Title
    Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.
    Detailed Description
    The present study aimed at evaluating the efficacy of mindfulness skills (M) versus interpersonal effectiveness skills (IE) on borderline symptoms. For that purpose, a randomized, active-controlled clinical trial was designed. 64 participants with borderline personality disorder (BPD) diagnosis were allocated to mindfulness (n=32) or interpersonal effectiveness skills (n=32). Both interventions were delivered over a 10-week period. The borderline symptom list (BSL-23) was elected as the primary outcome measure. Mindfulness related capacities, decentering and cognitive processing of social interactions were also evaluated with the Five Facet Mindfulness Questionnaire (FFMQ), the Experiences Questionnaire (EQ) and the Multidimensional Scale of Social Expression (EMES-C), respectively. Assessments were conducted pre and post interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Borderline Personality Disorder
    Keywords
    borderline personality disorder, mindfulness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness
    Arm Type
    Experimental
    Arm Description
    As proposed in dialectical behavioral therapy, mindfulness training consist of a set of behavioral skills that aim at improving patient's attentional control and emotional regulation.
    Arm Title
    Interpersonal effectiveness
    Arm Type
    Active Comparator
    Arm Description
    Interpersonal effectiveness skills are focused on improving interpersonal relationships and enhancing patient's ability to display social effective behavior.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness
    Intervention Description
    weekly psychotherapy sessions for 10 weeks (120 min each)
    Intervention Type
    Behavioral
    Intervention Name(s)
    interpersonal effectiveness
    Intervention Description
    weekly psychotherapy sessions for 10 weeks (120 min each)
    Primary Outcome Measure Information:
    Title
    change from baseline in borderline symptoms after a 10 week intervention
    Description
    participants were assessed pre and post interventions
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    change from baseline in decentering after a 10 week intervention
    Description
    participants were assessed pre and post interventions
    Time Frame
    10 weeks
    Title
    change from baseline in mindfulness facets after a 10 week intervention
    Description
    participants were assessed pre and post interventions
    Time Frame
    10 weeks
    Title
    change from baseline in social interactions after a 10 week intervention
    Description
    participants were assessed pre and post interventions
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Ages between 18 and 45 years BPD criteria according to two diagnostic interviews (SCID-II and DIB-R) Exclusion Criteria: Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder or mental retardation Participating in any sort of psychotherapy during the study or having participated in dialectical behavioral therapy groups in the past
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan C Pascual, PhD
    Organizational Affiliation
    Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32368793
    Citation
    Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
    Results Reference
    derived
    PubMed Identifier
    26759718
    Citation
    Soler J, Elices M, Pascual JC, Martin-Blanco A, Feliu-Soler A, Carmona C, Portella MJ. Effects of mindfulness training on different components of impulsivity in borderline personality disorder: results from a pilot randomized study. Borderline Personal Disord Emot Dysregul. 2016 Jan 11;3:1. doi: 10.1186/s40479-015-0035-8. eCollection 2016.
    Results Reference
    derived

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    Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

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