Back to resultsDBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder (DBT+Context)
Primary Purpose
Borderline Personality Disorders, BPD
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Combination DBT, self-compassion and contextual-based skills
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorders focused on measuring borderline personality disorder, long-lasting symptoms, dialectical behavior therapy skills, contextual approach.
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.
Sites / Locations
- Juan Carlos Pascual MateosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Combination of DBT-ST, self-compassion, and contextual-based skills.
Control Group
Arm Description
Combination of DBT-ST, self-compassion, and contextual-based skills.
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.
Outcomes
Primary Outcome Measures
Pemberton Happiness Index (PHI)
Happiness index (minimum 0- maximum 110) Higher scores better
Secondary Outcome Measures
Borderline Symptoms List-23 (BSL-23)
Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse
Remission from Depression Questionnaire (RDQ)
Depression (minimum 0- maximum 84). Higher scores worse
Self Compassion Scale Short Form (SCS-SF)
Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse
Satisfaction with life scale (SWLS)
Well being (5 items, minimum 5 - maximum 25). Higher scores better
Quality of life scale (WHO-QOL_BREF)
Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better
Full Information
NCT ID
NCT05972096
First Posted
July 17, 2023
Last Updated
July 25, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT05972096
Brief Title
DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder
Acronym
DBT+Context
Official Title
Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorders, BPD
Keywords
borderline personality disorder, long-lasting symptoms, dialectical behavior therapy skills, contextual approach.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination of DBT-ST, self-compassion, and contextual-based skills.
Arm Type
Experimental
Arm Description
Combination of DBT-ST, self-compassion, and contextual-based skills.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combination DBT, self-compassion and contextual-based skills
Intervention Description
Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills
Primary Outcome Measure Information:
Title
Pemberton Happiness Index (PHI)
Description
Happiness index (minimum 0- maximum 110) Higher scores better
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Borderline Symptoms List-23 (BSL-23)
Description
Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse
Time Frame
1 week
Title
Remission from Depression Questionnaire (RDQ)
Description
Depression (minimum 0- maximum 84). Higher scores worse
Time Frame
1 week
Title
Self Compassion Scale Short Form (SCS-SF)
Description
Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse
Time Frame
1 month
Title
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
Description
Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse
Time Frame
1 month
Title
Satisfaction with life scale (SWLS)
Description
Well being (5 items, minimum 5 - maximum 25). Higher scores better
Time Frame
1 month
Title
Quality of life scale (WHO-QOL_BREF)
Description
Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Pascual, PhD
Phone
34935537840
Email
jpascual@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Soler, PhD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Carlos Pascual Mateos
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Pascual, PhD
Phone
+34935537840
Email
jpascual@santpau.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder
We'll reach out to this number within 24 hrs