Borderline Personality Disorder (BPD)NCT06195553
Application and Effectiveness of the STEPPS in Patients with BPD, Extending to Their Families with the FC Program
A study testing STEPPS plus Family Connections and STEPPS in people with Borderline Personality Disorder (BPD), run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- STEPPS plus Family Connections and STEPPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Jaume I
Castellon, Spain, 12071
Soledad Quero, Psychology, +34964387641, squero@uji.es
Christian López, Psychology, 658243748 ext. +34, lopez_chrcru@gva.es
About this study
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
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.
Read the 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\'s Dialectical Behavior Therapy (DBT) and Bateman and Fonagy\'s Mentalization-Based Therapy as the two interventions with the highest level of recommendation. Another widely supported intervention is Blum\'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\'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.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- STEPPS plus Family Connections, STEPPS
- Keywords
- Personality disorder, borderline personality disorder, stepps, family connections, family focused therapy, family involvement, randomized controlled trial
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPPS plus Family ConnectionsBehavioural
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.
STEPPSBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: STEPPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
This questionnaire assesses the degree of self-validation or self-invalidation. It consists of 24 items rated on a scale from 1 (hardly ever) to 5 (always).
Measured: 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). Relatives's responses
This questionnaire assesses the purpose in life. It consists of 20 items rated on a scale from 1 (nothing) to 7 (very much).
Measured: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Measurement of acceptance and satisfaction. Treatment Opinion Scale (adapted from Borkovec & Nave, 1972). Relatives's responses
This questionnaire assesses the opinión about treatment at the end of the investigation. It consists of 7 items rated on a scale from 1 (nothing) to 7 (very much).
Measured: immediately after treatment, also at follow-up assessment periods (6 months)
Registry of family-patient critical incidents in the last three months. Relatives's responses
The registry consist of 6 questions about number of critical incidents such as suicide attempts or visits to the emergency room.
Measured: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start2 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with one treatment condition and one control condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de la Ribera
- Responsible party
- Sponsor
- Investigators
- Soledad Quero, Psychology, Study director, Universidad Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195553
- Sponsor's protocol ID
- STEPPSFCHULR
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19590999Liljedahl 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.
PubMed 31463066Hoffman 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.
PubMed 16013747Flynn 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.
PubMed 28861273Fernandez-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.
PubMed 32539740Dixon 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.
PubMed 11433107undefined
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06195553
- Acronym / sponsor ID
- STEPPSFCHULR
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- Personality disorder, borderline personality disorder, stepps, family connections, family focused therapy, family involvement, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital de la Ribera
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\'s Dialectical Behavior Therapy (DBT) and Bateman and Fonagy\'s Mentalization-Based Therapy as the two interventions with the highest level of recommendation. Another widely supported intervention is Blum\'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\'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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with one treatment condition and one control condition.
| Arm | Type | Receives |
|---|---|---|
| STEPPS for patients plus Family Connections for their families | Experimental | Behavioral: STEPPS plus Family ConnectionsIntervention 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. |
| STEPPS for patients only | Active comparator | Behavioral: STEPPSIntervention group that receives STEPPS program for patients only to carry out the intervention about BPD symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPPS plus Family ConnectionsThe 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. | Behavioural | STEPPS for patients plus Family Connections for their families |
| STEPPSThe 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. | Behavioural | STEPPS for patients only |
Primary outcome
BDI: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
8 secondary outcomes
BAS: Burden Assessment Scale (BAS; Reinhard et al., 1994). Relatives's responses
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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). Relatives's responses
Time frame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Measurement of acceptance and satisfaction. Treatment Opinion Scale (adapted from Borkovec & Nave, 1972). Relatives's responses
Time frame: immediately after treatment, also at follow-up assessment periods (6 months)
Registry of family-patient critical incidents in the last three months. Relatives's responses
Time frame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 19590999Rajalin 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.
- Background: PubMed 31463066Liljedahl 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.
- Background: PubMed 16013747Hoffman 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.
- Background: PubMed 28861273Flynn 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.
- Background: PubMed 32539740Fernandez-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.
- Background: PubMed 11433107Dixon 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.
- Backgroundundefined
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soledad Quero, Psychology study director
Universidad Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPPS plus Family Connections and STEPPS in people with Borderline Personality Disorder (BPD), run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian López, Psychology (096-438-7237 ext. +34, lopez_chrcru@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDI: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996). (time frame: At the beginning of the intervention and immediately after treatment, also at follow-up assessment periods (6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06195553, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.