NCT04856449

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

April 8, 2021

Last Update Submit

March 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Borderline Symptom List 23 (BSL-23)

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

    1 week

Secondary Outcomes (3)

  • Impact of Events Scale Revised

    1 week

  • Patient Health Questionnaire (PHQ-9)

    2 weeks

  • DISSOCIATIVE EXPERIENCES SCALE (DES)

    1 month

Study Arms (2)

DBT Skills Training

EXPERIMENTAL

This 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.

Behavioral: Dialectical Behavioral Therapy Skills Training

Eye Movement Desensitization and Reprocessing (EMDR)

ACTIVE COMPARATOR

EMDR 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.

Behavioral: EMDR

Interventions

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

Also known as: DBT-ST
DBT Skills Training
EMDRBEHAVIORAL

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

Eye Movement Desensitization and Reprocessing (EMDR)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Borderline Personality DisorderWounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 23, 2021

Study Start

September 6, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations