Effects of Mindfulness Training on Emotion Regulation and Impulsivity

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.

Study Overview

• Status: Completed
• Conditions: Mindfulness Skills; Interpersonal Effectiveness Skills
• Intervention / Treatment: Behavioral: Mindfulness skills training; Behavioral: Interpersonal Effectiveness skills training

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de La Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation Scale (DERS)	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.	1-past week
Barrat Impulsiveness Scale (BIS-11)	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.	1-past week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borderline Symptoms List (BSL-23)	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.	1-past-week

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: mindfulness; emotion regulation; impulsivity
• Additional Relevant MeSH Terms: Impulsive Behavior
• Other Study ID Numbers: IIBSP-TLP-2013-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No