DBT Skills Plus EMDR for BPD and Trauma

Trauma Clinical Trial

— TT-BPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856449
• Other study ID #: IIBSP-TLP-2020-105
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: May 2023

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Dialectical Behavioral Therapy Skills Training
DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.
• EMDR
EMDR sessions will be conducted to reprocess trauma-related memories.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	EMDR Europe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Borderline Symptom List 23 (BSL-23)	The scores range from a 0 to 4, with higher scores indicating a worse outcome.	1 week
Secondary	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
Secondary	Patient Health Questionnaire (PHQ-9)	The scores range from a 0 to 27, with higher scores indicating a worse outcome.	2 weeks
Secondary	DISSOCIATIVE EXPERIENCES SCALE (DES)	The scores range from 0 to 100, with higher scores representing a worse outcome.	1 month