DBT Skills Plus EMDR for BPD and Trauma

NCT ID: NCT04856449

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2023-05-31

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.

Conditions

Borderline Personality Disorder; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dialectical Behavioral Therapy Skills Training

Intervention Type: BEHAVIORAL

DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.

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.

Group Type: ACTIVE_COMPARATOR

EMDR

Intervention Type: BEHAVIORAL

EMDR sessions will be conducted to reprocess trauma-related memories.

Interventions

Dialectical Behavioral Therapy Skills Training

DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.

Intervention Type: BEHAVIORAL

EMDR

EMDR sessions will be conducted to reprocess trauma-related memories.

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT-ST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMDR Europe

INDUSTRY

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Juan C Pascual, PhD

Role: primary

jpascual@santpau.cat

+34935537843

Other Identifiers

IIBSP-TLP-2020-105

Identifier Type: -

Identifier Source: org_study_id