Clinical trial NCT06195553: Application and Effectiveness of the STEPPS in Patients with BPD, Extending to Their Families with the FC Program
Official title: Application and Analysis of the Effectiveness of the STEPPS Program in Patients with BPD, Extending to Their Families with the Family Connections Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder (BPD)
Keywords: Personality disorder
borderline personality disorder
stepps
family connections
family focused therapy
family involvement
randomized controlled trial
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Hospital de la Ribera
First posted: 2024-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with one treatment condition and one control condition.
Primary purpose: TREATMENT

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.

Detailed description: The literature so far seems to indicate that involving family members in psychotherapeutic interventions for patients diagnosed with Severe Mental Disorders (SMD) such as psychosis or bipolar disorder is effective, reducing hospitalizations and increasing treatment satisfaction. However, interventions with such characteristics have not been found for patients with Borderline Personality Disorder (BPD), one of the disorders included under the umbrella of SMD. Therefore, it seems necessary to develop and implement comprehensive programs involving families, given the benefits observed in other SMD diagnoses such as psychosis or bipolar disorder.

BPD is one of the personality disorders that receives significant clinical attention and research, with suicide being one of the most associated problems with this diagnosis, ranging from 3-10%. The prevalence of BPD in the general population is considered to be around 1%, rising to 12% in clinical populations and 22% in hospitalized patients. Meta-analysis studies place Linehan\&#39;s Dialectical Behavior Therapy (DBT) and Bateman and Fonagy\&#39;s Mentalization-Based Therapy as the two interventions with the highest level of recommendation. Another widely supported intervention is Blum\&#39;s Systems Training for Emotional Predictability and Problem Solving (STEPPS) program, especially effective when delivered in a group format within clinical and hospital settings due to its high adaptability. However, the issues described concerning patients with BPD inevitably lead to severe consequences in their work, emotional, and social environments. Relatives of individuals with BPD are more likely to experience psychological problems, burden, and depression. Generally, when family members participate in treatments, the patient\&#39;s relapses decrease, recovery becomes easier, and overall family well-being improves. Presently, interventions for relatives of patients with BPD exist. Family Connections (FC) has received the most empirical support. Nevertheless, to date, there have been no studies analyzing whether adding intervention programs for family members contributes to an improvement in the STEPPS program, which is precisely the aim of this current research. Specifically, the objective of this work is to compare the effectiveness of the STEPPS protocol for patients with BPD and their relatives, compared to the STEPPS protocol for patients alone and the Family Connections program for their relatives.

The Randomized Clinical Trial (RCT) will be conducted following the guidelines of the Consolidated Standards of Reporting Trials (CONSORT: http://www.consort-statement.org) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Participants (N=120) will be randomly assigned to two groups (after receiving a diagnosis of Borderline Personality Disorder according to the DSM-5): 1) STEPPS program for patients 2) STEPPS program for patients and Family Connections for their relatives. Participants in the second group may receive the Family Connections intervention for their relatives after completing the research evaluation period for ethical reasons. Outcome measures will be assessed at baseline, post-treatment, and at 6-month follow-ups. About stadistical analysis, separate statistical analyses will be performed for caregivers and patients. Intent to treat analyses will be performed using Linear Mixed Models (LMMs). The clinical significance of change observed in the scores of outcome measures from one assessment moment (baseline) to another (post-treatment) will be determined calculating the Reliable Change Indexes.

Eligibility criteria: PATIENTS

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: BDI: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months
measure: OASIS: Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Cissell, Means-Christensen, & Stein, 2006). Adapted into Spanish by Osma et al. (2019).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months
measure: INQ: The Interpersonal Needs Questionnaire (INQ; Van Order et al., 2012). We will use the Spanish version by Marco & Pérez (2016).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: 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).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: DERS: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2008). We will use the Spanish version by Hervás & Jódar (2008).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: BSL-23: Borderline Symptom List 23 (BSL-23; Bohus et al., 2008). We will use the Spanish version by Feliú-Soler et al. (2012).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: PIL-20: Purpose in Life-20 (PIL-20; Crumbaugh & Maholick, 1964).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: VIRS: Validating and Invalidating Responses Scale (VIRS; Fruzzetti, 2007).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: LEAP: Lum Emotional Availability of Parents (LEAP; Lum & Phares, 2005).
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: Registry of family-patient critical incidents in the last three months.
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Secondary outcomes:
measure: BAS: Burden Assessment Scale (BAS; Reinhard et al., 1994). Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: FES: Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: 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
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000). Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: SVSI-Q: The Self-Validation and Self-Invalidation Questionnaire (SVSI-Q; Fruzzetti & Davis, in preparation). Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: PIL-20: Purpose in Life-20 (PIL-20; Crumbaugh & Maholick, 1964). Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
measure: Measurement of acceptance and satisfaction. Treatment Opinion Scale (adapted from Borkovec & Nave, 1972). Relatives's responses
timeFrame: immediately after treatment, also at follow-up assessment periods (6 months)
measure: Registry of family-patient critical incidents in the last three months. Relatives's responses
timeFrame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Other outcomes:
Locations:
city: Castellón de la Plana
country: Spain
facility: Universitat Jaume I
Study officials:
affiliation: Universidad Jaume I
name: Soledad Quero, Psychology
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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