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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04856449
Other study ID # IIBSP-TLP-2020-105
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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