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CompletedNCT03363230Updated Dec 12, 2017

Effects of Mindfulness Training on Emotion Regulation and Impulsivity

An interventional study of Mindfulness skills training and Interpersonal Effectiveness skills training in Mindfulness Skills and Interpersonal Effectiveness Skills, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Mar 2015, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Mindfulness training has proven to be a reliable treatment for patients with Borderline Personality Disorder (BPD).The present randomized-controlled study examines the effects of mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either mindfulness or interpersonal effectiveness skills training. Assessments were conucted pre-and-post-intervention.

02

Conditions studied

  • Mindfulness Skills
  • Interpersonal Effectiveness Skills

Keywords

  • mindfulness
  • emotion regulation
  • impulsivity
03

In context

Emotional Regulation

545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.

This study's enrollment of 70 is below the median of 79 across 498 interventional studies indexed under Emotional Regulation.

Browse Emotional Regulation studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for Axis II disorders and the Revised Diagnostic Interview for Borderlines
  • Age between 18 and 50 years old
  • No comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
  • Not being participating in any other psychotherapy at the moment of the study.

Exclusion criteria

Exclusion criteria:

  • Having participated of skills training in the past.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Mindfulness skills

    Behavioral: Mindfulness skills training

  • Active comparator
    Interpersonal effectiveness skills

    Behavioral: Interpersonal Effectiveness skills training

Interventions

  • BehavioralMindfulness skills training

    Mindfulness skills were taught over a 10-week period. Mindfulness skills were delivered in a weekly group-format. Participants were instructed to follow mindfulness practice at home. The treatment was focused on enhancing the patient capacity to defuse from cognitive and emotional content.

  • BehavioralInterpersonal Effectiveness skills training

    Interpersonal effectiveness skills were taught over a 10-week period. Skills were delivered in a weekly group-format. The treatment was focused on improving interpersonal effectiveness.

06

What researchers measure

Primary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS)

    The DERS is a 28-item-scale that measures difficulties in emotion regulation. Each item has to be rated in a 5-point scale, with higher scores indicating higher difficulties in emotion regulation.

    Time frame: 1-past week

  2. Barrat Impulsiveness Scale (BIS-11)

    The current version of the Barratt Impulsiveness Scale is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point-scale, with higher scores indicating higher impulsivity.

    Time frame: 1-past week

Secondary outcomes

  1. Borderline Symptoms List (BSL-23)

    The BSL-23 assess common borderline symptoms during the past week (higher scores indicating higher borderline features). Items have to be rated on a 5-point-scale.

    Time frame: 1-past-week

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Study locations

1 site
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
08

References and documents

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 32368793 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Jul 2017, 28 months.

Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 28 months is above that.

Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2017
First posted
Dec 6, 2017
StartActual
Mar 1, 2015
Primary completionActual
Jul 1, 2017
CompletionActual
Jul 1, 2017
Last update
Dec 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03363230
Responsible party
Juan Carlos Pascual (Principal Investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau) — Principal investigator
First posted
Dec 6, 2017
Start date
Mar 1, 2015
Primary completion
Jul 1, 2017
Completion
Jul 1, 2017
Last update
Dec 12, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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