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RelativesNCT04160871

"Family Connections": a Program for Relatives of People With Borderline Personality Disorder

A study testing Family Connections and Treatment As Usual in people with Relatives, run by Universitat Jaume I at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Relatives
What is being tested?
Family Connections and Treatment As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSpain
Study dates
15 Nov 2019to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Verónica Guillén Botella, Dr contact

963864386 ext. 4386

vguillenbotella@gmail.com

Azucena García Palacios, Dr contact

964387640 ext. 7640

azucena@uji.es

Spain1 site, 1 recruiting
  • Universitat Jaume I

    Castellon, Castellón, 12071

    Verónica Guillén Botella, Dr, 963864386 ext. 4386, vguillenbotella@gmail.com

    Azucena García Palacios, Dr, 964387640 ext. 7640, azucena@uji.es

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Relatives
Being tested
Family Connections, Treatment As Usual
Keywords
borderline personality disorder, family connections, relatives, dbt, intervention, program, caregivers
Medical subject headings
Borderline Personality Disorder, Maple syrup urine disease, type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family ConnectionsBehavioural

    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.

  • Treatment As UsualBehavioural

    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.

Study groups in NCT04160871
Study groupRoleWhat they receive
Family ConnectionsExperimentalExperimental group
Receives: Behavioral: Family Connections
Treatment As UsualActive comparatorControl group
Receives: Behavioral: Treatment As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burden Assessment Scale (BAS; Reinhard & Horwitz, 1992).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  2. Family Assessment Device - Global Functioning Scale (FAD-GFS; Epstein, Baldwin & Bishop, 1983).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

Secondary outcomes (9)
  1. Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  2. Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Hervás & Jódar, 2008).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  3. Family Empowerment Scale (FES; Koren, DeChillo & Friesen, 1992).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  4. Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  5. Quality of Life Index-Spanish Version (QLI-Sp; Mezzich, Cohen, Ruipérez & Yoon, 1999).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  6. Beck Hopelessness Scale (BHS; Beck, Weissman, Lester & Trexler, 1974).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  7. Openness To the Future Scale (OFS; Botella et al., 2018).

    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).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month-follow-up.

  8. Personality Inventory for DSM-5 (PID-5; Krueger, Derringer, Markon, Watson & Skodol, 2012).

    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).

    Measured: Pre-treatment

  9. Structured Clinical Interview for DSM-IV Axis II (SCID-II; First, Gibbon, Spitzer, Williams & Benjamin, 1997).

    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).

    Measured: Pre-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start15 Nov 2019
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

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, Efficacy Study.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04160871
Sponsor's protocol ID
UJaumeI19-1
Status last verified
May 2020
First submitted
5 Nov 2019
Last updated
5 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available after deidentification.

Publications

  • Hoffman PD, Fruzzetti AE. Advances in interventions for families with a relative with a personality disorder diagnosis. Curr Psychiatry Rep. 2007 Feb;9(1):68-73. doi: 10.1007/s11920-007-0012-z.

    PubMed 17257517
  • 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.

    PubMed 16013747
  • Hoffman PD, Buteau E, Hooley JM, Fruzzetti AE, Bruce ML. Family members' knowledge about borderline personality disorder: correspondence with their levels of depression, burden, distress, and expressed emotion. Fam Process. 2003 Winter;42(4):469-78. doi: 10.1111/j.1545-5300.2003.00469.x.

    PubMed 14979218
  • Hoffman PD, Fruzzetti AE, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. doi: 10.1111/j.1545-5300.1999.00399.x.

    PubMed 10668619
  • 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.

    PubMed 28861273
  • 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 19590999
  • Guillen V, Bolo S, Fonseca-Baeza S, Perez S, Garcia-Alandete J, Botella C, Marco JH. Psychological assessment of parents of people diagnosed with borderline personality disorder and comparison with parents of people without psychological disorders. Front Psychol. 2023 Jan 13;13:1097959. doi: 10.3389/fpsyg.2022.1097959. eCollection 2022.

    PubMed 36710828
  • 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.

    PubMed 32539740

Questions about this trial

What is this clinical trial studying?

A study testing Family Connections and Treatment As Usual in people with Relatives, 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 4 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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Verónica Guillén Botella, Dr (963864386 ext. 4386, vguillenbotella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 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 NCT04160871, which also lists 8 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 5 May 2020.

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