Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06195553

Study of the STEPPS Program for Borderline Personality Disorder Patients With or Without Family Connections Program for Their Families A Randomized Controlled Trial Evaluating Combined Behavioral Treatments

Led by Universitat Jaume I · Updated on 2025-01-15

120

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

U

Universitat Jaume I

Lead Sponsor

H

Hospital de la Ribera

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating Borderline Personality Disorder (BPD), a common and challenging mental health condition within the National Health System. This study aims to evaluate whether combining treatments for patients and their families leads to greater improvements compared to treating patients alone. The research also focuses on assessing how well these intervention programs are accepted and their feasibility for patients, families, and clinical professionals. The trial compares two groups: one receiving the STEPPS program, a cognitive and behavioral treatment focusing on psychoeducation and emotional and behavioral regulation skills for patients; and another group receiving STEPPS for patients plus the Family Connections program for their relatives, which includes dialectical and behavioral treatment with psychoeducation, skills training, and peer support. Family members in the STEPPS-only group may receive Family Connections after the study ends for ethical reasons. Participants will be evaluated at the start, immediately after treatment, and at six months follow-up using various measures including depression, anxiety, emotion regulation, borderline symptoms, quality of life, and family interactions. Researchers will track critical family-patient incidents and analyze results separately for patients and caregivers. The total participation duration includes baseline, post-treatment, and follow-up assessments to understand changes and treatment effects.

CONDITIONS

Official Title

Application and Effectiveness of the STEPPS in Patients with BPD, Extending to Their Families with the FC Program

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 18 years old
  • Be a patient with symptoms compatible with Borderline Personality Disorder undergoing treatment or follow-up at a recruitment center
  • Provide signed informed consent
  • Be at least 18 years old
  • Be a relative of a patient with symptoms compatible with Borderline Personality Disorder undergoing treatment or follow-up at a recruitment center
  • Provide signed informed consent
Not Eligible

You will not qualify if you...

  • Have any condition preventing participation such as major depression, psychosis, schizophrenia, substance dependence, eating disorders, another personality disorder, or borderline IQ that currently interferes with functioning
  • Have any condition preventing participation such as major depression, psychosis, schizophrenia, substance dependence, eating disorders, another personality disorder, or borderline IQ that currently interferes with functioning

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universitat Jaume I

Castellon, Spain, Spain, 12071

Actively Recruiting

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Research Team

C

Christian López, Psychology

C

Christian López, Psychology

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study.

Sophie I Liljedahl, Nikolaus Kleindienst, Margit Wångby-Lundh...

https://pubmed.ncbi.nlm.nih.gov/31463066

Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study.

Daniel Flynn, Mary Kells, Mary Joyce...

https://pubmed.ncbi.nlm.nih.gov/28861273

Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial.

Isabel Fernández-Felipe, Verónica Guillén, Helio Marco...

https://pubmed.ncbi.nlm.nih.gov/32539740