DBT Skills Plus EMDR for BPD and Trauma (TT-BPD)

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma; Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Dialectical Behavioral Therapy Skills Training; Behavioral: EMDR

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Recruiting
      • Hospital De La Santa Creu I Sant Pau
      • Contact: Juan C Pascual, PhD; Phone Number: +34935537843; Email: jpascual@santpau.cat
      • Principal Investigator: Joaquim Soler, PhD
      • Sub-Investigator: Juan C Pascual, PhD
      • Sub-Investigator: Matilde Elices, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBT Skills Training; 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; DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.; Other Names: DBT-ST
Active Comparator: Eye Movement Desensitization and Reprocessing (EMDR); 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; EMDR sessions will be conducted to reprocess trauma-related memories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borderline Symptom List 23 (BSL-23)	The scores range from a 0 to 4, with higher scores indicating a worse outcome.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 week
Patient Health Questionnaire (PHQ-9)	The scores range from a 0 to 27, with higher scores indicating a worse outcome.	2 weeks
DISSOCIATIVE EXPERIENCES SCALE (DES)	The scores range from 0 to 100, with higher scores representing a worse outcome.	1 month

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: EMDR Europe

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Wounds and Injuries; Borderline Personality Disorder
• Other Study ID Numbers: IIBSP-TLP-2020-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No