NCT02397031

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

March 12, 2015

Last Update Submit

March 23, 2015

Conditions

Borderline Personality Disorder

Keywords

borderline personality disordermindfulness

Outcome Measures

Primary Outcomes (1)

  • change from baseline in borderline symptoms after a 10 week intervention

    participants were assessed pre and post interventions

    10 weeks

Secondary Outcomes (3)

  • change from baseline in decentering after a 10 week intervention

    10 weeks

  • change from baseline in mindfulness facets after a 10 week intervention

    10 weeks

  • change from baseline in social interactions after a 10 week intervention

    10 weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

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.

Behavioral: Mindfulness

Interpersonal effectiveness

ACTIVE COMPARATOR

Interpersonal effectiveness skills are focused on improving interpersonal relationships and enhancing patient's ability to display social effective behavior.

Behavioral: interpersonal effectiveness

Interventions

MindfulnessBEHAVIORAL

weekly psychotherapy sessions for 10 weeks (120 min each)

Mindfulness
interpersonal effectivenessBEHAVIORAL

weekly psychotherapy sessions for 10 weeks (120 min each)

Interpersonal effectiveness

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages between 18 and 45 years
  • BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 32368793DERIVED

  • 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.

    PMID: 26759718DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Juan C Pascual, PhD

    Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03