DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder

BPD Clinical Trial

— DBT+Context  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972096
• Other study ID #: IIBSP-TLP-2020-104
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: July 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Juan Carlos Pascual, PhD
• Phone: 34935537840
• Email: jpascual[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Borderline Personality Disorders
• BPD
• Personality Disorders

Intervention

Behavioral:
• Combination DBT, self-compassion and contextual-based skills
Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills

Locations

Country	Name	City	State
Spain	Juan Carlos Pascual Mateos	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pemberton Happiness Index (PHI)	Happiness index (minimum 0- maximum 110) Higher scores better	1 month
Secondary	Borderline Symptoms List-23 (BSL-23)	Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse	1 week
Secondary	Remission from Depression Questionnaire (RDQ)	Depression (minimum 0- maximum 84). Higher scores worse	1 week
Secondary	Self Compassion Scale Short Form (SCS-SF)	Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse	1 month
Secondary	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
Secondary	Satisfaction with life scale (SWLS)	Well being (5 items, minimum 5 - maximum 25). Higher scores better	1 month
Secondary	Quality of life scale (WHO-QOL_BREF)	Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better	2 weeks