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Trial record 1 of 1 for:    NCT04160871
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"Family Connections": a Program for Relatives of People With Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT04160871
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Universitat Jaume I

Brief Summary:
The aim of this study is to validate an intervention for relatives of people with borderline personality disorder in Spanish population in a randomized control trial.

Condition or disease Intervention/treatment Phase
Relatives Behavioral: Family Connections Behavioral: Treatment As Usual Not Applicable

Detailed Description:
Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. It consists of 12 sessions with an approximate duration of two hours each. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. The investigators have translated and adapted the program so that it could be applied to the Spanish population. The aim of the present study is to evaluate the effectiveness of the adaptation of "Family connections" in Spanish population through a controlled clinical trial. The first hypothesis of the study is that "Family Connections" will be more effective (significant reduction in the primary outcome variables), compared with a Treatment As Usual (TAU), in the posttest time and in the follow-ups of 3 and 6 months. In addition, a second hypothesis is that "Family Connections" will be more efficient (fewer abandonments, better opinion on the part of the patients) than TAU.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Efficacy Study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of "Family Connections", a Program for Relatives of People With Borderline Personality Disorder in Spanish Population: A Study Protocol for a Randomized Control Trial
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Family Connections
Experimental group
Behavioral: Family Connections
Intervention includes 12 sessions that follow a group format of 2 hours with a weekly frequency. FC program (Hoffman and Fruzzetti, 2005) is divided into six modules: 1: Updated information and research on BPD; 2: Psychoeducation on the development of BPD, available treatments and comorbidity; 3: Individual skills: self-control of emotions, mindfulness, reality acceptance skills, validation skills, etc. and skills of relationship to promote emotional well-being problem management (family skills); 4: Family skills to improve the quality of relationships in family interactions; 5: Communication skills and effective self-expression; and 6: Problem management. All modules include Practice exercises and homework. In addition, throughout the program, in order to increase social support, the FC program provides a forum where participants can stay in touch, share common problems and solutions.

Active Comparator: Treatment As Usual
Control group
Behavioral: Treatment As Usual
The intervention lasts for 3 months and includes 12 sessions that follow a group format of 2 hours and with a weekly frequency. It includes the following components: Psychoeducation about personality disorders and, specifically, BPD and how these disorders evolve. Problems associated with BPD (eg, alcohol and / or drug use, eating disorders, etc.). The importance of "modeling" in family members: change of attitude towards difficult situations to reduce the escalation of tension and re-establish a healthy relationship between the patient and family. The handling of problems. Crisis management: Development of safe plans for when the patient is in emotional escalation.




Primary Outcome Measures :
  1. Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Burden Assessment Scale (BAS) consists of 19 items and it assess the caregivers' objective and subjective burden within the past six months. Items are rated on a 4-point Likert scale ranging from 1(nothing) to 4 (a lot), and higher values indicate stronger burden. Internal reliability of the scale ranged from .89 to .91 and it shows adequated validity (Reinhard, Gubman, Horwitz & Minsky, 1994).

  2. Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Family Assessment Device - Global Functioning Scale (FAD-GFS) is a self-report questionnaire (Epstein, Baldwin & Bishop, 1983). It consists of 60 items about family functioning. It is composed of seven subscales: Problem-Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control and General Functioning. Items are rated on a 4-point Likert scale ranging from 1 (totally agree) to 4 (totally disagree), and higher scores indicate unhealthy functioning. Cronbach's alphas ranges from .72 to .83 for the subscales and general functioning is .92 (Miller, Epstein, Bishop & Keitner, 1985) and test-retest for the FAD scales were adequate (Miller, Epstein, Bishop & Keitner, 1985).


Secondary Outcome Measures :
  1. Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Depression, Anxiety and Stress Scale (DASS) have 42 items about negative emotional symptoms (Lovibond & Lovibond, 1995). Lovibond & Lovinbod (1995) proposed that a part of these subscales for can become part of a short version creating a new questionnaire of 21 items. Items are rated on a 4-point Likert scale ranging from 0 (It did not happen to me) to 3 (It happened to me a lot or most of the time), and higher scores indicate worse symptoms of depression, anxiety or stress. DASS-21 showed fantastic factor structures. Regarding to the internal consistency, Cronbach's alphas were excellent for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) (Antony, Bieling, Cox, Enns & Swinson, 1998).

  2. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    We used the spanish version of the instrument Difficulties in Emotion Regulation Scale (DERS), developed by Gratz y Roemer (2004), with the aim to assess the emotional regulation problem. The scale was adapted to spanish and it was reduced from 36 items to 28 items (Hervás & Jódar, 2008). In this version, they figured on 5 scales instead 6 considering that "difficulties in the impulse control" and "limited access to regulation strategies" were joined into one named "emotional lack of control". The subscales are life interference, emotional confusion, emotional rejection, emotional lack of control and lack of emotional attention. Items are rated on a 5-point Likert scale ranging from 1 (rarely) to 5 (almost always), and higher scores indicate greater impairment or dysregulation. The psychometric properties show high consistency were Cronbach's alphas of the subscales range from .73 to .91 and .93 for the total scale (Hervás & Jódar, 2008).

  3. Family Empowerment Scale (FES; Koren, DeChillo & Friesen, 1992). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Family Empowerment Scale (FES) consists of 34 items divided in three subscales: family, service system, and involvement in community that is refered to three ways of empowerment, attitudes, knowledge, and behaviors (Koren, DeChillo & Friesen, 1992). Items are rated on a scale of 1 (completely false) to 5 (totally true), and higher scores indicate a greater sense of empowerment. The psychometric properties are the following: regarding to the internal consistency of FES subscores, the coefficients ranged from .87 to .88 and validity and reliability are adequated (Koren, DeChillo & Friesen, 1992).

  4. Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Connor-Davidson Resilience scale is a 25-item measure of resilience. Items are rated on a 5-point Likert scale ranging from 0 (absolutely not) to 4 (almost always) and the punctuation is based on how the participant has felt over the last month. Higher scores means greater resilience (Connor & Davidson, 2003). The CD-RISC authors reported acceptable test-retest reliability (r = 0.87) and strong internal consistency (α = .89) (Connor & Davidson, 2003).

  5. Quality of Life Index-Spanish Version (QLI-Sp; Mezzich, Cohen, Ruipérez & Yoon, 1999). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Quality of Life Index-Spanish Version consist of 10 items that assess aspects as physical, psychological/emotional well-being, self-care and independent functioning, occupational and interpersonal functioning, social-emotional and community and services support, personal and spiritual fulfillment and global perception of quality life. Items are rated on a scale of 1 (bad) to 10 (excellent), and higher scores means higher quality of life. This instrument has good psychometric properties as Cronbach's alpha of .89 and high test-retest reliability (r = 0.87) (Mezzich et al., 2000).

  6. Beck Hopelessness Scale (BHS; Beck, Weissman, Lester & Trexler, 1974). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Beck Hopelessness Scale is a 20-item true-false instrument utilized for the measurement of hopelessness. It evaluates the attitude of the participant in the previous week. Nine items assess attitudes about the future and eleven items assess pessimistic statements. Items are rated as true or false, and higher scores reflects higher levels of hopelessness. Good psychometric properties are shown in this instrument. Internal consistency was excellent (α = .93) (Beck, Weissman, Lester & Trexler, 1974).

  7. Openness To the Future Scale (OFS; Botella et al., 2018). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Openness Towards the Future Scale is a 10-items self-report that measures positive affective orientation towards the future. Items are rated on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree), and higher scores indicate better openness to the future. It shows adequate psychometric properties for both clinical and general samples. Cronbach's alpha was acceptable for both clinical (α = .82) and community samples (α = .87) (Botella et al., 2018).

  8. Personality Inventory for DSM-5 (PID-5; Krueger, Derringer, Markon, Watson & Skodol, 2012). [ Time Frame: Pre-treatment ]
    Personality Inventory for DSM-5 (PID-5) is a 220-item instrument that assesses 25 traits, which form five domains (Negative Affectivity, Detachment, Antagonism, Disinhibition, and Psychoticism). The 25 traits are the following: Anhedonia, Anxiousness, Attention Seeking, Callousness, Deceitfulness, Depressivity, Distractibility, Eccentricity, Emotional Lability, Grandiosity, Hostility, Impulsivity, Intimacy Avoidance, Irresponsibility, Manipulativeness, Perceptual Dysregulation, Perseveration, Restricted Affectivity, Rigid Perfectionism, Risk Taking, Separation Insecurity, Submissiveness, Suspiciousness, Unusual Beliefs and Experiences, and Withdrawal. Items are ranged on a 4-point Likert scale ranging from 0 (totally disagree) to 3 (totally agree), and higher average scores indicate more "dysfunction" in a specific personality trait facet or domain. Internal consistency ranged from .72 to .96 with a median of .86 (Krueger, Derringer, Markon, Watson & Skodol, 2012).

  9. Structured Clinical Interview for DSM-IV Axis II (SCID-II; First, Gibbon, Spitzer, Williams & Benjamin, 1997). [ Time Frame: Pre-treatment ]
    Structured Clinical Interview for DSM-IV Axis II consists of a semistructured format involving 10 standard DSM-IV personality disorders and the Personality Disorder Not Otherwise Specified, Depressive Personality Disorder and Passive-Aggressive Personality Disorder. Items are rated as "yes" or "no", and two or more scores on "yes" mean that participant may have a personality disorder and should be evaluated with the interview, and you have to assess the personality disorder depending on the punctuation of each (5 items or more: dependent, depressive, squizotypal, histrionic, narcissistic and borderline; 4 items or more: avoidant, obsessive-compulssive, passive-agressive, paranoid and schizoid; 3 items or more: antisocial; 1 item or more: non-specified. Adequate inter-rater reliability coefficients were reported (.48-.98) and satisfactory internal consistency coefficients (ranges from .71 to .94) (Maffei et al. 1997).


Other Outcome Measures:
  1. Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    This instrument is also carried out in the evaluation of patients. Family Assessment Device - Global Functioning Scale (FAD-GFS) is a self-report questionnaire (Epstein, Baldwin & Bishop, 1983). It consists of 60 items about family functioning. It is composed of seven subscales: Problem-Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behavior Control and General Functioning. Items are rated on a 4-point Likert scale ranging from 1 (totally agree) to 4 (totally disagree), and higher scores indicate unhealthy functioning. Cronbach's alphas ranges from .72 to .83 for the subscales and general functioning is .92 (Miller, Epstein, Bishop & Keitner, 1985) and test-retest for the FAD scales were adequate (Miller, Epstein, Bishop & Keitner, 1985).

  2. Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    This instrument is also carried out in the evaluation of patients. Depression, Anxiety and Stress Scale (DASS) have 42 items about negative emotional symptoms (Lovibond & Lovibond, 1995). Lovibond & Lovinbod (1995) proposed that a part of these subscales for can become part of a short version creating a new questionnaire of 21 items. Items are rated on a 4-point Likert scale ranging from 0 (It did not happen to me) to 3 (It happened to me a lot or most of the time), and higher scores indicate worse symptoms of depression, anxiety or stress. DASS-21 showed fantastic factor structures. Regarding to the internal consistency, Cronbach's alphas were excellent for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) (Antony, Bieling, Cox, Enns & Swinson, 1998).

  3. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    This instrument is also carried out in the evaluation of patients. Difficulties in Emotion Regulation Scale (DERS), developed by Gratz y Roemer (2004), with the aim to assess the emotional regulation problem. The scale was adapted to spanish and it was reduced from 36 items to 28 items (Hervás & Jódar, 2008). In this version, they figured on 5 scales instead 6 considering that "difficulties in the impulse control" and "limited access to regulation strategies" were joined into one named "emotional lack of control". The subscales are life interference, emotional confusion, emotional rejection, emotional lack of control and lack of emotional attention. Items are rated on a 5-point Likert scale ranging from 1 (rarely) to 5 (almost always), and higher scores indicate greater impairment or dysregulation. The psychometric properties show high consistency were Cronbach's alphas of the subscales range from .73 to .91 and .93 for the total scale (Hervás & Jódar, 2008).

  4. Lum Emotional Availability of Parents (LEAP; Lum & Phares, 2005). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Lum Emotional Availability of Parents consists of 15 items that involves participants' mothers and fathers emotional availability. Items are rated on a 6-point Likert scale ranging from 1 (never) to 6 (always), and higher scores indicate better emotional availability. Internal consistency was excellent for non-clinical sample for the mother form (α = .96) and for father form (α = .97); also for the mother form in a clinical sample (α = .92), and for the father form (α = .93). This instrument has adequated test-retest reliability for the mother form (r = .92) and for the father form (r = .85) (Lum & Phares, 2005).

  5. Validating and Invalidating Responses Scale (VIRS; Fruzzetti, 2007). [ Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up. ]
    Validating and Invalidating Responses Scale is a 16-items self-report which evaluates levels of validation and invalidation of caregiver's responses. This instrument has two subscales: validation and invalidation responses. This two are moderately correlated. Items are rated on a 5-point Likert scale, ranging from 0 (never) to 4 (almost all the time), and higher scores indicate more perceived validation or invalidation from the caregiver who is assessed. There are no psychometric properties available on the VIRS yet.

  6. Post-Module measures (P-M) [ Time Frame: Immediately after the intervention ]
    Post-Module is an instrument constructed by our research team oriented to assess the level of change obtained with respect to the therapeutic modules as well as the degree of satisfaction to receive the treatment. It evaluates the six modules of the treatment in the two conditions. There are two subscales: one evaluates the learning of the abilities of the module and it is rated from 0 (nothing) to 10 (a lot), and the other evaluates how the module has helped to the caregiver to improve several aspects such as knowing and understanding the problem, emotion's comprehension, mindfulness of the relationship with their relative, acceptance, family atmosphere and problem solving on the family atmosphere, and it is rated from 1 (nothing) to 4 (a lot). Expectation scale is assessed on the end of the first module.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 years or older.
  • Having a relative with DSM-5 diagnosis of Personality Disorder
  • Understand spoken and written Spanish.
  • Grant informed consent.

Exclusion Criteria:

  • Diagnosis of severe mental disorder.
  • Presence of medical illness that may interfere with psychological treatment.
  • Suicide risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160871


Contacts
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Contact: Verónica Guillén Botella, Dr 963864386 ext 4386 vguillenbotella@gmail.com
Contact: Azucena García Palacios, Dr 964387640 ext 7640 azucena@uji.es

Locations
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Spain
Universitat Jaume I Recruiting
Castellón De La Plana, Castellón, Spain, 12071
Contact: Verónica Guillén Botella, Dr    963864386 ext 4386    vguillenbotella@gmail.com   
Contact: Azucena García Palacios, Dr    964387640 ext 7640    azucena@uji.es   
Principal Investigator: Verónica Guillén Botella, Dr         
Principal Investigator: Azucena García Palacios, Dr         
Principal Investigator: José Heliodoro Marco Salvador, Dr         
Principal Investigator: Isabel Fernández Felipe, PhD Student         
Principal Investigator: Amanda Díaz García, Dr         
Principal Investigator: Cristina Botella Arbona, Dr         
Sponsors and Collaborators
Universitat Jaume I
University of Valencia
Investigators
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Principal Investigator: José Heliodoro Marco Salvador, Dr University of Valencia
Principal Investigator: Isabel Fernández Felipe, PhD student Universitat Jaume I
Principal Investigator: Amanda Díaz García, Dr Universitat Jaume I
Principal Investigator: Cristina Botella Arbona, Dr Universitat Jaume I
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT04160871    
Other Study ID Numbers: UJaumeI19-1
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will be available immediately following publication.
Access Criteria: The data will be available to anyone who wishes to access them.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitat Jaume I:
borderline personality disorder
family connections
relatives
dbt
intervention
program
caregivers
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders