DBT Skills Plus EMDR for BPD and Trauma (TT-BPD)
Primary Purpose
Borderline Personality Disorder, Trauma
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dialectical Behavioral Therapy Skills Training
EMDR
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder
Eligibility Criteria
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
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DBT Skills Training
Eye Movement Desensitization and Reprocessing (EMDR)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Borderline Symptom List 23 (BSL-23)
The scores range from a 0 to 4, with higher scores indicating a worse outcome.
Secondary Outcome Measures
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)
Patient Health Questionnaire (PHQ-9)
The scores range from a 0 to 27, with higher scores indicating a worse outcome.
DISSOCIATIVE EXPERIENCES SCALE (DES)
The scores range from 0 to 100, with higher scores representing a worse outcome.
Full Information
NCT ID
NCT04856449
First Posted
April 8, 2021
Last Updated
March 15, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
EMDR Europe
1. Study Identification
Unique Protocol Identification Number
NCT04856449
Brief Title
DBT Skills Plus EMDR for BPD and Trauma
Acronym
TT-BPD
Official Title
A Pilot Randomized-controlled Study of Dialectical Behavioral Skills Training Plus EMDR for Borderline Personality Disorder and Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
EMDR Europe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DBT Skills Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Eye Movement Desensitization and Reprocessing (EMDR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavioral Therapy Skills Training
Other Intervention Name(s)
DBT-ST
Intervention Description
DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
EMDR sessions will be conducted to reprocess trauma-related memories.
Primary Outcome Measure Information:
Title
Borderline Symptom List 23 (BSL-23)
Description
The scores range from a 0 to 4, with higher scores indicating a worse outcome.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Impact of Events Scale Revised
Description
The scores range from a 0 to 25, with higher scores indicating a higher impact of the traumatic event (worse outcome)
Time Frame
1 week
Title
Patient Health Questionnaire (PHQ-9)
Description
The scores range from a 0 to 27, with higher scores indicating a worse outcome.
Time Frame
2 weeks
Title
DISSOCIATIVE EXPERIENCES SCALE (DES)
Description
The scores range from 0 to 100, with higher scores representing a worse outcome.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan C Pascual, PhD
Phone
+34935537843
Email
jpascual@santpau.cat
First Name & Middle Initial & Last Name & Degree
Joaquim Soler, PhD
First Name & Middle Initial & Last Name & Degree
Juan C Pascual, PhD
First Name & Middle Initial & Last Name & Degree
Matilde Elices, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DBT Skills Plus EMDR for BPD and Trauma
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