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Effects of Mindfulness Training on Emotion Regulation and Impulsivity

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ClinicalTrials.gov Identifier: NCT03363230
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Juan Carlos Pascual, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.

Condition or disease Intervention/treatment Phase
Mindfulness Skills Interpersonal Effectiveness Skills Behavioral: Mindfulness skills training Behavioral: Interpersonal Effectiveness skills training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Arm Intervention/treatment
Experimental: Mindfulness skills Behavioral: Mindfulness skills training
Mindfulness skills were taught over a 10-week period. Mindfulness skills were delivered in a weekly group-format. Participants were instructed to follow mindfulness practice at home. The treatment was focused on enhancing the patient capacity to defuse from cognitive and emotional content.
Active Comparator: Interpersonal effectiveness skills Behavioral: Interpersonal Effectiveness skills training
Interpersonal effectiveness skills were taught over a 10-week period. Skills were delivered in a weekly group-format. The treatment was focused on improving interpersonal effectiveness.



Primary Outcome Measures :
  1. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 1-past week ]
    The DERS is a 28-item-scale that measures difficulties in emotion regulation. Each item has to be rated in a 5-point scale, with higher scores indicating higher difficulties in emotion regulation.

  2. Barrat Impulsiveness Scale (BIS-11) [ Time Frame: 1-past week ]
    The current version of the Barratt Impulsiveness Scale is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point-scale, with higher scores indicating higher impulsivity.


Secondary Outcome Measures :
  1. Borderline Symptoms List (BSL-23) [ Time Frame: 1-past-week ]
    The BSL-23 assess common borderline symptoms during the past week (higher scores indicating higher borderline features). Items have to be rated on a 5-point-scale.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV Axis II disorders and the Revised Diagnostic Interview for Borderlines
  • Age between 18 and 50 years old
  • No comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
  • Not being participating in any other psychotherapy at the moment of the study.

Exclusion criteria:

• Having participated of skills training in the past.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363230


Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party: Juan Carlos Pascual, Principal Investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03363230     History of Changes
Other Study ID Numbers: IIBSP-TLP-2013-115
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Carlos Pascual, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
mindfulness
emotion regulation
impulsivity

Additional relevant MeSH terms:
Impulsive Behavior