Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06195553

Effectiveness of the STEPPS Program in Borderline Personality Disorder Patients and Their Families Using Family Connections: A Randomized Controlled Trial

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

120

Participants Needed

1

Research Sites

52 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 studying Borderline Personality Disorder (BPD), a common and challenging mental health condition, to see if combining treatment programs for patients and their families leads to better outcomes. The study aims to assess the effectiveness and acceptance of these combined intervention programs among patients, families, and clinical professionals, focusing on improving symptoms and family well-being. This is a randomized clinical trial following established research guidelines. The trial compares two groups: one receives the STEPPS program for patients alongside the Family Connections program for their families, while the other group receives only the STEPPS program for patients. STEPPS involves cognitive and behavioral treatment focusing on psychoeducation, emotional regulation, and behavioral skills. Family Connections includes psychoeducation, skills training, and peer support for relatives. Participants are randomly assigned to these groups, and family members in the STEPPS-only group may receive Family Connections after the study evaluation period for ethical reasons. Participants will be assessed at the start, immediately after treatment, and six months later using various measures of depression, anxiety, emotion regulation, borderline symptoms, quality of life, and family-related factors. Both patients and family members will complete questionnaires and keep a registry of critical family-patient incidents. The study will monitor acceptance, satisfaction, and clinical changes over time to evaluate the programs' feasibility and impact during the trial period.

CONDITIONS

Brief 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
  • Have symptoms consistent with a diagnosis of Borderline Personality Disorder and be receiving treatment or follow-up at a recruitment center
  • Sign informed consent to participate
  • Be a relative of a patient with Borderline Personality Disorder receiving treatment or follow-up at a recruitment center
  • Relatives must be at least 18 years old
  • Relatives must sign informed consent to participate
Not Eligible

You will not qualify if you...

  • Presence of any condition interfering with participation, such as major depression, psychosis, schizophrenia, substance dependence, eating disorders, another personality disorder, or borderline IQ
  • Conditions must be currently severe enough to prevent carrying out the intervention
  • Applies to both patients and relatives

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Duration of the STEPPS and Family Connections programs as per treatment schedule

Participants receive the STEPPS program to manage Borderline Personality Disorder symptoms. Some participants' families may also receive the Family Connections program to support associated symptoms.

Group sessions for patients and families over the treatment period

Follow-up

Duration - 6 months

Participants and their families are assessed for treatment outcomes and symptom changes at 6 months after treatment completion.

1 follow-up visit

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