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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02397031
Other study ID # IIBSP-MOD-2011-147
Secondary ID
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


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
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