NCT05972096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 17, 2023

Last Update Submit

July 25, 2023

Conditions

Keywords

borderline personality disorderlong-lasting symptomsdialectical behavior therapy skillscontextual approach.

Outcome Measures

Primary Outcomes (1)

  • Pemberton Happiness Index (PHI)

    Happiness index (minimum 0- maximum 110) Higher scores better

    1 month

Secondary Outcomes (6)

  • Borderline Symptoms List-23 (BSL-23)

    1 week

  • Remission from Depression Questionnaire (RDQ)

    1 week

  • Self Compassion Scale Short Form (SCS-SF)

    1 month

  • Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)

    1 month

  • Satisfaction with life scale (SWLS)

    1 month

  • +1 more secondary outcomes

Study Arms (2)

Combination of DBT-ST, self-compassion, and contextual-based skills.

EXPERIMENTAL

Combination of DBT-ST, self-compassion, and contextual-based skills.

Behavioral: Combination DBT, self-compassion and contextual-based skills

Control Group

PLACEBO COMPARATOR

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

Interventions

Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills

Combination of DBT-ST, self-compassion, and contextual-based skills.Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Carlos Pascual Mateos

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Joaquim Soler, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos Pascual, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 2, 2023

Study Start

March 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations