AzTrials
AzTrials

Borderline Personality DisorderTT-BPDNCT04856449

DBT Skills Plus EMDR for BPD and Trauma

A study testing Dialectical Behavioral Therapy Skills Training and EMDR in people with Borderline Personality Disorder and Trauma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Borderline Personality Disorder, Trauma
What is being tested?
Dialectical Behavioral Therapy Skills Training and EMDR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
6 Sep 2021to May 2023
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • men and women between 18 and 60 years old
  • having had adverse childhood experiences and/or current PTSD symptoms
  • signed informed consent

Who cannot join

  • lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder, or mental retardation.
  • participation in any psychotherapy during the study or having received DBT or EMDR in the past

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

    Juan C Pascual, PhD, +34935537843, jpascual@santpau.cat

    Joaquim Soler, PhD

    Recruiting

Other trials in Spain

About this study

Official title: A Pilot Randomized-controlled Study of Dialectical Behavioral Skills Training Plus EMDR for Borderline Personality Disorder and Trauma

Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Dialectical behavioral skills training (DBT-ST), is a group-delivered training that covers four types of skills: emotion regulation, mindfulness, interpersonal effectiveness and distress tolerance. As a stand-alone treatment, research suggest that DBT-ST is an efficacious treatment for BPD. In parallel, EMDR has emerged in last years as an efficacious approach to adult trauma. However, so far, the efficacy of EMDR to treat trauma in populations with BPD diagnosis has not been tested. The present pilot randomized-controlled clinical trial aims to test whether a combination of DBT-ST plus EMDR could be efficacious to treat trauma in individuals with BPD. 40 participants will be recruited from the BPD Unit at the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain) and will be randomized (1:1) to DBT-ST + EMDR or DBT-ST alone. The primary outcome will be the reduction of PTSD symptoms. In addition, symptom-related variables will be collected before and after the interventions. This will be the first study to test the combination of DBT-ST and EMDR.

Being tested
Dialectical Behavioral Therapy Skills Training, EMDR
Medical subject headings
Borderline Personality Disorder, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavioral Therapy Skills TrainingBehavioural

    Also called DBT-ST

    DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.

  • EMDRBehavioural

    EMDR sessions will be conducted to reprocess trauma-related memories.

Study groups in NCT04856449
Study groupRoleWhat they receive
DBT Skills TrainingExperimentalThis intervention will consist of a 6-month-group DBT-skills training continuation, in which participants will be trained in mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness.
Receives: Behavioral: Dialectical Behavioral Therapy Skills Training
Eye Movement Desensitization and Reprocessing (EMDR)Active comparatorEMDR will consist of individual therapy sessions that will be focused on processing traumatic memories. Participants will receive up to 16 individual EMDR sessions, of 60 min each.
Receives: Behavioral: EMDR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Borderline Symptom List 23 (BSL-23)

    The scores range from a 0 to 4, with higher scores indicating a worse outcome.

    Measured: 1 week

Secondary outcomes (3)

  1. Impact of Events Scale Revised

    The scores range from a 0 to 25, with higher scores indicating a higher impact of the traumatic event (worse outcome)

    Measured: 1 week

  2. Patient Health Questionnaire (PHQ-9)

    The scores range from a 0 to 27, with higher scores indicating a worse outcome.

    Measured: 2 weeks

  3. DISSOCIATIVE EXPERIENCES SCALE (DES)

    The scores range from 0 to 100, with higher scores representing a worse outcome.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start6 Sep 2021
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856449
Sponsor's protocol ID
IIBSP-TLP-2020-105
Acronym
TT-BPD
Status last verified
Mar 2023
First submitted
8 Apr 2021
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Soler J, Elices M, Canosa-Garcia I, Schmidt C, Lupo W, Valiente-Gomez A, Amann BL, Perez-Sola V, Pascual JC. The combination of dialectical behavioral skills training with EMDR in the treatment of borderline personality disorder and psychological trauma: a feasibility randomized trial. Borderline Personal Disord Emot Dysregul. 2026 Jun 12. doi: 10.1186/s40479-026-00351-5. Online ahead of print.

    PubMed 42286717

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavioral Therapy Skills Training and EMDR in people with Borderline Personality Disorder and Trauma, 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 3 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Borderline Symptom List 23 (BSL-23) (time frame: 1 week). 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 NCT04856449, 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 16 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in