Effects of Mindfulness Training on Emotion Regulation and Impulsivity

Mindfulness Skills Clinical Trial

Official title:

Effects of Mindfulness Training on Emotion Regulation and Impulsivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363230
• Other study ID #: IIBSP-TLP-2013-115
• Status: Completed
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 11, 2017
• Start date: March 1, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: November 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impulsive Behavior
• Interpersonal Effectiveness Skills
• Mindfulness Skills

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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