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RecruitingNCT05972096DBT+ContextUpdated Aug 2, 2023

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

An interventional study of Combination DBT, self-compassion and contextual-based skills in Borderline Personality Disorders and BPD, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2022, registered Jul 2023).
  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Borderline Personality Disorders
  • BPD

Keywords

  • borderline personality disorder
  • long-lasting symptoms
  • dialectical behavior therapy skills
  • contextual approach.
03

In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 229 interventional studies indexed under Personality Disorders.

Browse Personality Disorders studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralCombination DBT, self-compassion and contextual-based skills

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

06

What researchers measure

Primary outcomes

  1. Pemberton Happiness Index (PHI)

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

    Time frame: 1 month

Secondary outcomes

  1. Borderline Symptoms List-23 (BSL-23)

    Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse

    Time frame: 1 week

  2. Remission from Depression Questionnaire (RDQ)

    Depression (minimum 0- maximum 84). Higher scores worse

    Time frame: 1 week

  3. Self Compassion Scale Short Form (SCS-SF)

    Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse

    Time frame: 1 month

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

    Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse

    Time frame: 1 month

  5. Satisfaction with life scale (SWLS)

    Well being (5 items, minimum 5 - maximum 25). Higher scores better

    Time frame: 1 month

  6. Quality of life scale (WHO-QOL_BREF)

    Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Juan Carlos Pascual Mateos
    Barcelona, 08041, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05972096
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Aug 2, 2023
Start date
Mar 1, 2022
Primary completion
Oct 1, 2023 (estimated)
Completion
Oct 1, 2023 (estimated)
Last update
Aug 2, 2023

Study contacts

Juan Carlos Pascual, PhD
Contact
jpascual@santpau.cat
34935537840
Joaquim Soler, PhD
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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