Effects of Mindfulness Training on Emotion Regulation and Impulsivity

NCT03363230 | Completed DMC

• 1 other identifier: IIBSP-TLP-2013-115
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness Skills; Interpersonal Effectiveness Skills

Keywords

mindfulness; emotion regulation; impulsivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Borderline Symptoms List (BSL-23)

  1-past-week

Study Arms (2)

Mindfulness skills

EXPERIMENTAL

Behavioral: Mindfulness skills training

Interpersonal effectiveness skills

ACTIVE COMPARATOR

Behavioral: Interpersonal Effectiveness skills training

Interventions

Mindfulness skills training BEHAVIORAL

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.

Mindfulness skills

Interpersonal Effectiveness skills training BEHAVIORAL

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.

Interpersonal effectiveness skills

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Having participated of skills training in the past.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

• 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.

  PMID: 32368793 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Impulsive Behavior

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: March 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)