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

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ClinicalTrials.gov Identifier: NCT05972096
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorders BPD Behavioral: Combination DBT, self-compassion and contextual-based skills Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination of DBT-ST, self-compassion, and contextual-based skills.
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


Outcome Measures
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Primary Outcome Measures :
  1. Pemberton Happiness Index (PHI) [ Time Frame: 1 month ]
    Happiness index (minimum 0- maximum 110) Higher scores better


Secondary Outcome Measures :
  1. Borderline Symptoms List-23 (BSL-23) [ Time Frame: 1 week ]
    Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse

  2. Remission from Depression Questionnaire (RDQ) [ Time Frame: 1 week ]
    Depression (minimum 0- maximum 84). Higher scores worse

  3. Self Compassion Scale Short Form (SCS-SF) [ Time Frame: 1 month ]
    Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse

  4. Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS) [ Time Frame: 1 month ]
    Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse

  5. Satisfaction with life scale (SWLS) [ Time Frame: 1 month ]
    Well being (5 items, minimum 5 - maximum 25). Higher scores better

  6. Quality of life scale (WHO-QOL_BREF) [ Time Frame: 2 weeks ]
    Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972096


Contacts
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Contact: Juan Carlos Pascual, PhD 34935537840 jpascual@santpau.cat

Locations
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Spain
Juan Carlos Pascual Mateos Recruiting
Barcelona, Spain, 08041
Contact: Juan Carlos Pascual, PhD    +34935537840    jpascual@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Joaquim Soler, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT05972096    
Other Study ID Numbers: IIBSP-TLP-2020-104
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
borderline personality disorder
long-lasting symptoms
dialectical behavior therapy skills
contextual approach.
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders