- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02397031
Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
March 23, 2015 updated by: Juan Carlos Pascual, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness
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.
|
weekly psychotherapy sessions for 10 weeks (120 min each)
|
ACTIVE_COMPARATOR: Interpersonal effectiveness
Interpersonal effectiveness skills are focused on improving interpersonal relationships and enhancing patient's ability to display social effective behavior.
|
weekly psychotherapy sessions for 10 weeks (120 min each)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline in borderline symptoms after a 10 week intervention
Time Frame: 10 weeks
|
participants were assessed pre and post interventions
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline in decentering after a 10 week intervention
Time Frame: 10 weeks
|
participants were assessed pre and post interventions
|
10 weeks
|
change from baseline in mindfulness facets after a 10 week intervention
Time Frame: 10 weeks
|
participants were assessed pre and post interventions
|
10 weeks
|
change from baseline in social interactions after a 10 week intervention
Time Frame: 10 weeks
|
participants were assessed pre and post interventions
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan C Pascual, PhD, Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
April 1, 2014
Study Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
March 12, 2015
First Submitted That Met QC Criteria
March 18, 2015
First Posted (ESTIMATE)
March 24, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
March 25, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-MOD-2011-147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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