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
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, mindfulness
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
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
NCT ID
NCT02397031
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
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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