Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397031
• Other study ID #: IIBSP-MOD-2011-147
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 23, 2015
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Centro Etico de Investigación Clinica IIB Sant Pau
• Study type: Interventional

Clinical Trial 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.

Description:

The present study aimed at evaluating the efficacy of mindfulness skills (M) versus interpersonal effectiveness skills (IE) on borderline symptoms. For that purpose, a randomized, active-controlled clinical trial was designed. 64 participants with borderline personality disorder (BPD) diagnosis were allocated to mindfulness (n=32) or interpersonal effectiveness skills (n=32). Both interventions were delivered over a 10-week period. The borderline symptom list (BSL-23) was elected as the primary outcome measure. Mindfulness related capacities, decentering and cognitive processing of social interactions were also evaluated with the Five Facet Mindfulness Questionnaire (FFMQ), the Experiences Questionnaire (EQ) and the Multidimensional Scale of Social Expression (EMES-C), respectively. Assessments were conducted pre and post interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• Ages between 18 and 45 years

• BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Mindfulness
weekly psychotherapy sessions for 10 weeks (120 min each)
• interpersonal effectiveness
weekly psychotherapy sessions for 10 weeks (120 min each)

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in borderline symptoms after a 10 week intervention	participants were assessed pre and post interventions	10 weeks	No
Secondary	change from baseline in decentering after a 10 week intervention	participants were assessed pre and post interventions	10 weeks	No
Secondary	change from baseline in mindfulness facets after a 10 week intervention	participants were assessed pre and post interventions	10 weeks	No
Secondary	change from baseline in social interactions after a 10 week intervention	participants were assessed pre and post interventions	10 weeks	No