Mindfulness SkillsNCT03363230
Effects of Mindfulness Training on Emotion Regulation and Impulsivity
A study testing Mindfulness skills training and Interpersonal Effectiveness skills training in people with Mindfulness Skills and Interpersonal Effectiveness Skills, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mindfulness Skills, Interpersonal Effectiveness Skills
- What is being tested?
- Mindfulness skills training and Interpersonal Effectiveness skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2015to 1 Jul 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV 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.
Who cannot join
- Having participated of skills training in the past.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Mindfulness skills training, Interpersonal Effectiveness skills training
- Keywords
- mindfulness, emotion regulation, impulsivity
- Medical subject headings
- Emotional Regulation, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness skills trainingBehavioural
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.
Interpersonal Effectiveness skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness skills | Experimental | Not described Receives: Behavioral: Mindfulness skills training |
| Interpersonal effectiveness skills | Active comparator | Not described Receives: Behavioral: Interpersonal Effectiveness skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-past week
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.
Measured: 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.
Measured: 1-past-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Mar 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mindfulness SkillsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363230
- Sponsor's protocol ID
- IIBSP-TLP-2013-115
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 32368793
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Training on Emotion Regulation and Impulsivity
- ClinicalTrials.gov ID
- NCT03363230
- Acronym / sponsor ID
- IIBSP-TLP-2013-115
- Keywords
- mindfulness, emotion regulation, impulsivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness skills | Experimental | Behavioral: Mindfulness skills training |
| Interpersonal effectiveness skills | Active comparator | Behavioral: Interpersonal Effectiveness skills training |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV 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.
Key exclusion criteria (1 listed)
- Having participated of skills training 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 |
|---|---|---|
| Mindfulness skills trainingMindfulness 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. | Behavioural | Mindfulness skills |
| Interpersonal Effectiveness skills trainingInterpersonal 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. | Behavioural | Interpersonal effectiveness skills |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 1-past week
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.
Barrat Impulsiveness Scale (BIS-11)
Time frame: 1-past week
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.
1 secondary outcome
Borderline Symptoms List (BSL-23)
Time frame: 1-past-week
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 12 Dec 2017.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness skills training and Interpersonal Effectiveness skills training in people with Mindfulness Skills and Interpersonal Effectiveness Skills, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 inclusion and 1 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Difficulties in Emotion Regulation Scale (DERS) (time frame: 1-past week). The study lists 2 primary outcomes in all. 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 NCT03363230, which also lists 1 linked publication.
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 12 Dec 2017.