Clinical trial NCT05972096: DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder
Official title: Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorders
BPD
Keywords: borderline personality disorder
long-lasting symptoms
dialectical behavior therapy skills
contextual approach.
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial aims to test the efficacy of this expanded skills DBT-based intervention with self-compassion and contextual-based skills targeting long-lasting BPD compared with treatment as usual.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pemberton Happiness Index (PHI)
timeFrame: 1 month
Secondary outcomes:
measure: Borderline Symptoms List-23 (BSL-23)
timeFrame: 1 week
measure: Remission from Depression Questionnaire (RDQ)
timeFrame: 1 week
measure: Self Compassion Scale Short Form (SCS-SF)
timeFrame: 1 month
measure: Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
timeFrame: 1 month
measure: Satisfaction with life scale (SWLS)
timeFrame: 1 month
measure: Quality of life scale (WHO-QOL_BREF)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Juan Carlos Pascual Mateos
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Joaquim Soler, PhD
role: PRINCIPAL_INVESTIGATOR
References: