DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder (DBT+Context)

Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder

Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. The prevalence of this subsample of individuals is considerably increasing last years. New interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting BPD.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorders; BPD
• Intervention / Treatment: Behavioral: Combination DBT, self-compassion and contextual-based skills

Detailed Description

Sixty individuals with BPD and long lasting symptoms that have been received previously dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized clinical trial. They will be randomly assigned to receive an add-on skills training intervention involving the combination of DBT-ST, self-compassion, and contextual-based skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be evaluated pre and post intervention and 3-month follow-up. The outcome measures are well-being indicators and clinical variables.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Carlos Pascual, PhD; Phone Number: 34935537840; Email: jpascual@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Juan Carlos Pascual Mateos
    • Contact: Juan Carlos Pascual, PhD; Phone Number: +34935537840; Email: jpascual@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults between 18 and 65 years of age
• Primary diagnosis of BPD according to Diagnostic Statistical Manual IV criteria and by the structured interviews: Diagnosis Structured clinical interview for axis II personality disorders (SCID II; First et al. 1997) and Diagnostic Interview for Borderlines Revised (DIB-R)
• Previous participation in DBT-ST intervention
• Signed informed consent.

Exclusion Criteria:

• Presence of life-threatening behaviors in the last 12 months
• PTSD or related symptoms
• Diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic disorder
• Intellectual disability
• Participation in any other psychotherapy treatment during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of DBT-ST, self-compassion, and contextual-based skills.	Behavioral: Combination DBT, self-compassion and contextual-based skills; Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills
Placebo Comparator: Control Group; Treatment as usual. Although these individuals did not receive any new specific psychotherapeutic intervention for BPD, they valued the higher frequency of psychiatric visits, attention in crisis, family care, and greater experience and sensitivity in the management of BPD.	Behavioral: Combination DBT, self-compassion and contextual-based skills; Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pemberton Happiness Index (PHI)	Happiness index (minimum 0- maximum 110) Higher scores better	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borderline Symptoms List-23 (BSL-23)	Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse	1 week
Remission from Depression Questionnaire (RDQ)	Depression (minimum 0- maximum 84). Higher scores worse	1 week
Self Compassion Scale Short Form (SCS-SF)	Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse	1 month
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)	Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse	1 month
Satisfaction with life scale (SWLS)	Well being (5 items, minimum 5 - maximum 25). Higher scores better	1 month
Quality of life scale (WHO-QOL_BREF)	Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better	2 weeks

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Joaquim Soler, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: borderline personality disorder; long-lasting symptoms; dialectical behavior therapy skills; contextual approach.
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: IIBSP-TLP-2020-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No