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

NCT06195553 | Recruiting

• 1 other identifier: STEPPSFCHULR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The present research project is framed within the issue of Borderline Personality Disorder (BPD). This condition stands as one of the most common challenges encountered within the mental health services of the National Health System. The primary objectives of this research are to verify whether the combined use of established treatments for patients and their families, conducted in parallel, leads to a greater improvement in patients and their families, respectively. Additionally, another aim of the project is to assess efficiency, defined as the acceptance of intervention programs by patients, their families, and clinical professionals, as well as to demonstrate their feasibility.

Conditions

Borderline Personality Disorder (BPD)

Keywords

Personality disorder; borderline personality disorder; stepps; family connections; family focused therapy; family involvement; randomized controlled trial

Outcome Measures

Primary Outcomes (11)

• BDI: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996).

  This questionnaire assesses the degree of depressive symptomatology in the last week. It consists of 21 items rated on a scale from 0 (nothing) to 3 (very much).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months

• OASIS: Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Cissell, Means-Christensen, & Stein, 2006). Adapted into Spanish by Osma et al. (2019).

  This questionnaire assesses the degree of anxiety symptomatology in the last week. It consists of 5 items rated on a scale from 0 (mild) to 4 (extreme).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months

• INQ: The Interpersonal Needs Questionnaire (INQ; Van Order et al., 2012). We will use the Spanish version by Marco & Pérez (2016).

  This questionnaire assesses the degree of interpersonal needs currently. It consists of 15 items rated on a scale from 1 (nothing true) to 7 (totally true).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• ACWRSS: The Acquired Capability with Rehearsal for Suicide Scale (ACWRSS; George et al., 2016). We will use the Spanish version by Marco et al. (2020).

  This questionnaire assesses the acquired capability with rehearsal for suicide. It consists of 7 items rated on a scale from 0 (disagreement) to 8 (agreement).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• DERS: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2008). We will use the Spanish version by Hervás & Jódar (2008).

  This questionnaire assesses the ability to regulate emotions. It consists of 28 items rated on a scale from 1 (hardly never) to 5 (almost always).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• BSL-23: Borderline Symptom List 23 (BSL-23; Bohus et al., 2008). We will use the Spanish version by Feliú-Soler et al. (2012).

  This questionnaire assesses the degree of symptoms of borderline personality disorders in the last week. It consists of 23 items rated on a scale from 0 (never) to 4 (very much) and 11 items rated on a scale from 0 (nothing) to 4 (daily).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000).

  This questionnaire assesses the level of quality of life currently. It consists of 10 items rated on a scale from 1 (bad) to 10 (excellent).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• PIL-20: Purpose in Life-20 (PIL-20; Crumbaugh & Maholick, 1964).

  This questionnaire assesses the purpose in life. It consists of 20 items rated on a scale from 1 (nothing) to 7 (very much).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• VIRS: Validating and Invalidating Responses Scale (VIRS; Fruzzetti, 2007).

  This questionnaire assesses the degree of validated or invalidating responses from the family in the last week. It consists of 15 items rated on a scale from 0 (never) to 4 (almost every time).

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• LEAP: Lum Emotional Availability of Parents (LEAP; Lum & Phares, 2005).

  This questionnaire assesses the perception of emotional availability from the parents. It consists of 15 items rated on a scale from 0 to 6 about the father and 0 to 6 about the mother.

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• Registry of family-patient critical incidents in the last three months.

  The registry consist of 6 questions about number of critical incidents such as suicide attempts or visits to the emergency room.

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

Secondary Outcomes (8)

• BAS: Burden Assessment Scale (BAS; Reinhard et al., 1994). Relatives's responses

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• FES: Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). Relatives's responses

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• DASS-21: Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995). We will use the Spanish version by Bados, Solanas, & Andrés (2005). Relatives's responses

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000). Relatives's responses

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

• SVSI-Q: The Self-Validation and Self-Invalidation Questionnaire (SVSI-Q; Fruzzetti & Davis, in preparation). Relatives's responses

  At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)

Study Arms (2)

STEPPS for patients plus Family Connections for their families

EXPERIMENTAL

Intervention group that receives STEPPS program for patients to carry out the intervention about BPD symptoms and in parallel another group that receives Family Connectios program for their families to carry out the intervention about associated symptoms.

Behavioral: STEPPS plus Family Connections

STEPPS for patients only

ACTIVE COMPARATOR

Intervention group that receives STEPPS program for patients only to carry out the intervention about BPD symptoms.

Behavioral: STEPPS

Interventions

STEPPS plus Family Connections BEHAVIORAL

The intervention will be based on cognitive and behavior treatment using STEPPS for the patients and dialectical and behavior treatment using Family Connections for the families. Main components STEPPS: psychoeducation, emotional regulation skills and behavioral regulation skills. Main components Family Connections: psychoeducation, skills training and peer support.

STEPPS for patients plus Family Connections for their families

STEPPS BEHAVIORAL

The intervention will be based on cognitive and behavior treatment using STEPPS for the patients. Main components STEPPS: psychoeducation, emotional regulation skills and behavioral regulation skills. Waiting list group: Participant's relatives of this group will be able to receive the Family Connections intervention after the research end.

STEPPS for patients only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old.
• Be a patients with symptoms compatible with a diagnosis of BPD who is undergoing treatment or follow-up in someone of the indicated recruitment centers.
• Sign an informed consent.

You may not qualify if:

• The presence of any pathology that prevents carrying out the intervention: major depression, psychosis, schizophrenia, substance dependence, eating disorders, another personality disorder, borderline IQ, etc., which due to its severity is currently interfering.
• FAMILIES:
• Being at least 18 years old.
• Be a relative of someone of the patients with symptoms compatible with a diagnosis of BPD who is undergoing treatment or follow-up in someone of the indicated recruitment centers.
• Sign an informed consent.
• The presence of any pathology that prevents carrying out the intervention: major depression, psychosis, schizophrenia, substance dependence, eating disorders, another personality disorder, borderline IQ, etc., which due to its severity is currently interfering.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Hospital de la Ribera: collaborator

Study Sites (1)

Universitat Jaume I

Castellon, Spain, 12071, Spain

RECRUITING

Related Publications (7)

• Rajalin M, Wickholm-Pethrus L, Hursti T, Jokinen J. Dialectical behavior therapy-based skills training for family members of suicide attempters. Arch Suicide Res. 2009;13(3):257-63. doi: 10.1080/13811110903044401.

  PMID: 19590999 BACKGROUND

• Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.

  PMID: 31463066 BACKGROUND

• Hoffman PD, Fruzzetti AE, Buteau E, Neiditch ER, Penney D, Bruce ML, Hellman F, Struening E. Family connections: a program for relatives of persons with borderline personality disorder. Fam Process. 2005 Jun;44(2):217-25. doi: 10.1111/j.1545-5300.2005.00055.x.

  PMID: 16013747 BACKGROUND

• Flynn D, Kells M, Joyce M, Corcoran P, Herley S, Suarez C, Cotter P, Hurley J, Weihrauch M, Groeger J. Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.

  PMID: 28861273 BACKGROUND

• Fernandez-Felipe I, Guillen V, Marco H, Diaz-Garcia A, Botella C, Jorquera M, Banos R, Garcia-Palacios A. 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. BMC Psychiatry. 2020 Jun 15;20(1):302. doi: 10.1186/s12888-020-02708-8.

  PMID: 32539740 BACKGROUND

• Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.

  PMID: 11433107 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder; Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Soledad Quero, Psychology

  Universidad Jaume I

  STUDY DIRECTOR

Central Study Contacts

Christian López, Psychology

CONTACT

096-438-7237; lopez_chrcru@gva.es

Christian López, Psychology

CONTACT

065-824-3748; lopez_chrcru@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with one treatment condition and one control condition.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 2, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)