Borderline Personality DisorderNCT02397031
Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
A study testing Mindfulness and interpersonal effectiveness in people with Borderline Personality Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Mindfulness and interpersonal effectiveness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages between 18 and 45 years
- BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)
Who cannot join
- 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
About this study
Official title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Mindfulness, interpersonal effectiveness
- Keywords
- borderline personality disorder, mindfulness
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
weekly psychotherapy sessions for 10 weeks (120 min each)
interpersonal effectivenessBehavioural
weekly psychotherapy sessions for 10 weeks (120 min each)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: interpersonal effectiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in borderline symptoms after a 10 week intervention
participants were assessed pre and post interventions
Measured: 10 weeks
Secondary outcomes (3)
change from baseline in decentering after a 10 week intervention
participants were assessed pre and post interventions
Measured: 10 weeks
change from baseline in mindfulness facets after a 10 week intervention
participants were assessed pre and post interventions
Measured: 10 weeks
change from baseline in social interactions after a 10 week intervention
participants were assessed pre and post interventions
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Pascual, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Juan C Pascual, PhD, Principal investigator, Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397031
- Sponsor's protocol ID
- IIBSP-MOD-2011-147
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32368793Soler 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.
PubMed 26759718
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT02397031
- Acronym / sponsor ID
- IIBSP-MOD-2011-147
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessAs 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. |
| Interpersonal effectiveness | Active comparator | Behavioral: interpersonal effectivenessInterpersonal effectiveness skills are focused on improving interpersonal relationships and enhancing patient's ability to display social effective behavior. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages between 18 and 45 years
- BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulnessweekly psychotherapy sessions for 10 weeks (120 min each) | Behavioural | Mindfulness |
| interpersonal effectivenessweekly psychotherapy sessions for 10 weeks (120 min each) | Behavioural | Interpersonal effectiveness |
Primary outcome
change from baseline in borderline symptoms after a 10 week intervention
Time frame: 10 weeks
participants were assessed pre and post interventions
3 secondary outcomes
change from baseline in decentering after a 10 week intervention
Time frame: 10 weeks
change from baseline in mindfulness facets after a 10 week intervention
Time frame: 10 weeks
change from baseline in social interactions after a 10 week intervention
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 32368793Storebo 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.
- Derived from this study: PubMed 26759718Soler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Pascual, PhD principal investigator
Servei de Psiquitria. Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and interpersonal effectiveness in people with Borderline Personality Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in borderline symptoms after a 10 week intervention (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.