Clinical trial NCT02397031: Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Official title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
mindfulness
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in borderline symptoms after a 10 week intervention
timeFrame: 10 weeks
Secondary outcomes:
measure: change from baseline in decentering after a 10 week intervention
timeFrame: 10 weeks
measure: change from baseline in mindfulness facets after a 10 week intervention
timeFrame: 10 weeks
measure: change from baseline in social interactions after a 10 week intervention
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau
name: Juan C Pascual, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.