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

Condition(s) studied

Investigational drug(s) / intervention(s)

STEPPS plus Family Connections: 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: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• BDI: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months
  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).
• OASIS: Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Cissell, Means-Christensen, & Stein, 2006). Adapted into Spanish by Osma et al. (2019). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months
  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).
• INQ: The Interpersonal Needs Questionnaire (INQ; Van Order et al., 2012). We will use the Spanish version by Marco & Pérez (2016). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• 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). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• DERS: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2008). We will use the Spanish version by Hervás & Jódar (2008). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• BSL-23: Borderline Symptom List 23 (BSL-23; Bohus et al., 2008). We will use the Spanish version by Feliú-Soler et al. (2012). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• PIL-20: Purpose in Life-20 (PIL-20; Crumbaugh & Maholick, 1964). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  This questionnaire assesses the purpose in life. It consists of 20 items rated on a scale from 1 (nothing) to 7 (very much).
• VIRS: Validating and Invalidating Responses Scale (VIRS; Fruzzetti, 2007). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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).
• LEAP: Lum Emotional Availability of Parents (LEAP; Lum & Phares, 2005). — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  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.
• Registry of family-patient critical incidents in the last three months. — At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
  The registry consist of 6 questions about number of critical incidents such as suicide attempts or visits to the emergency room.

Trial sites (1)

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