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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05972096

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorders BPD	Behavioral: Combination DBT, self-compassion and contextual-based skills	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Mar 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Pemberton Happiness Index (PHI) [1 month]
Happiness index (minimum 0- maximum 110) Higher scores better

Secondary Outcome Measures

Borderline Symptoms List-23 (BSL-23) [1 week]
Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse
Remission from Depression Questionnaire (RDQ) [1 week]
Depression (minimum 0- maximum 84). Higher scores worse
Self Compassion Scale Short Form (SCS-SF) [1 month]
Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS) [1 month]
Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse
Satisfaction with life scale (SWLS) [1 month]
Well being (5 items, minimum 5 - maximum 25). Higher scores better
Quality of life scale (WHO-QOL_BREF) [2 weeks]
Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.