Application and Effectiveness of the STEPPS in Patients with BPD, Extending to Their Families with the FC Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Jaume I
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
STEPPS plus Family Connections
BehavioralThe 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
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: STEPPS for patients plus Family Connections for their familiesExperimental treatment 1 intervention
Group B: STEPPS for patients onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months2
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).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months3
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).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)4
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).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)Secondary outcomes
1
BAS: Burden Assessment Scale (BAS; Reinhard et al., 1994). Relatives's responses
This questionnaire assesses the level of disease burden in the last 6 months. It consists of 19 items rated on a scale from 1 (nothing) to 4 (very much).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)2
FES: Family Empowerment Scale (FES; Koren, DeChillo, & Friesen, 1992). Relatives's responses
This questionnaire assesses the degree of perception of mastery and empowerment. It consists of 34 items rated on a scale from 1 (totally false) to 4 (totally true).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)3
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
This questionnaire assesses the degree of depression, anxiety and stress in the last week. It consists of 21 items rated on a scale from 0 (never) to 3 (very much).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)4
QLI: Quality of Life Index (QLI; Ferrans & Powers, 1985). We will use the Spanish version by Mezzich et al. (2000). Relatives's responses
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).
Time frame
At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat Jaume I
Lead sponsor
Hospital de la Ribera
Collaborator
Source ClinicalTrials.gov