Trauma Clinical Trial
— TT-BPDOfficial title:
A Pilot Randomized-controlled Study of Dialectical Behavioral Skills Training Plus EMDR for Borderline Personality Disorder and Trauma
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | EMDR Europe |
Spain,
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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