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RelativesFC-ED&PDNCT05404035

"Family Connections" for Caregivers of People With Eating Disorders and Personality Disorders.

A study testing Family Connections for relatives of people with eating disorders and personality disorders and Optimized Treatment As Usual in people with Relatives, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study is to verify the efficacy of the Family Connections intervention for relatives of people diagnosed with eating disorders and personality disorders in a randomized control trial with a Spanish participants. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Relatives
What is being tested?
Family Connections for relatives of people with eating disorders and personality disorders and Optimized Treatment As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSpain
Study dates
23 May 2022to 20 Nov 2024
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Having a family member diagnosed with eating disorders and personality disorders (or personality disorder traits).
  • Being 18 years of age or older.
  • Knowing and understanding the Spanish language.
  • Completing the informed consent.

Who cannot join

  • The presence of any pathology in the family member that keeps the intervention from being carried out (such as psychosis, schizophrenia, intellectual disability, substance dependence, etc.) will be an exclusion criterion.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: "Family Connections" an Intervention for Caregivers of People With Eating Disorders and Personality Disorders: Study Protocol for a Randomized Controlled Trial.

The aim of our study is to verify the efficacy of the Family Connections intervention for relatives of people diagnosed with eating disorders and personality disorders in a randomized control trial with a Spanish participants.

Read the detailed description

Eating disorders (EDs) are serious mental health problems that cause disturbances related to food intake and lead to major concerns about weight and body shape. In addition, they have an impact on social functioning and lead to psychological symptoms such as depression and anxiety, social isolation, interpersonal difficulties, low self-esteem, and reduced autonomy. These disorders share a high comorbidity with personality disorders (PD) that ranges from 27-93%, leading to increased severity and worse quality of life. Families of people with ED perceive a high burden of the illness and report mental health problems. Existing intervention programs specifically targeting caregivers of people with ED are based on psychoeducation, systemic cognitive-behavioral therapy, although specific treatments for family members of people with ED and PD are still scarce. However, a skills training program called "Family Connections" (FC) was developed by Hoffman and Fruzzetti's group for borderline personality disorder (BPD). It is a program consisting of 12 two-hour sessions that take place weekly. It is divided into six modules that include psychoeducation about the disorder and how it affects family functioning, and skills adapted from Dialectical Behavior Therapy, such as mindfulness, emotional regulation, validation, radical acceptance, and problem management, among others. In addition, all the modules include specific practical exercises, video examples, and homework. There is also a forum where family members build an emotional support network. So far, the results of this program in non-randomized clinical trials show significant decreases in the subjective experience of burden of illness, perceived distress, and depression, as well as improvements in coping strategies. The aims of this study are the following: (a) to adapt and test, in the Spanish population, the modules of the FC intervention protocol, designed to be applied specifically to relatives of patients with ED and PD; (b) to test the efficacy of FC in reducing the perceived burden of illness and clinical symptomatology in relatives of patients with ED and PD and improving family relationships and quality of life; (c) to test its efficiency, understood as the acceptance of the intervention program by the participants and clinicians, and demonstrate its viability; (d) to carry out an effective dissemination of this protocol. This paper presents the study protocol. The study design consists of a two-arm randomized controlled trial with two conditions: Family Connections (FC-ED \& PD) or Treatment as usual optimized (TAU-O). Participants will be family members of patients with eating disorders and personality disorders (or dysfunctional personality traits) according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The caregivers' primary outcome measures will be the BAS and a Family-Patient Critical Incident Record. Secondary outcomes will be the EDSIS, FAD-GD, MEMs, MQLI, DASS-21, DERS, and QoL. The patients' primary outcome measures will be a Family-Patient Critical Incident Record, the EAT-26, PHQ-9, OASIS, VIRS, and LEAP. Participants will be assessed at pre-treatment, post-treatment, and twelve months follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation.

Conditions
Relatives
Being tested
Family Connections for relatives of people with eating disorders and personality disorders, Optimized Treatment As Usual
Keywords
Intervention, family members, caregivers, eating disorders, personality disorders
Medical subject headings
Feeding and Eating Disorders, Personality Disorders

What participants receive

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

  • Family Connections for relatives of people with eating disorders and personality disordersBehavioural

    The FC program (Fruzzetti and Hoffman, 2005) is divided into 7 modules:

    1. Introduction to the intervention program. Program objectives, guidelines, criteria, and symptoms of ED and PD.
    2. Psychoeducation on the development of ED and PD, explanatory theories, available treatments, comorbidity with PD.
    3. Emotional regulation skills and awareness, and to decrease emotional reactivity.
    4. Skills to improve the quality of relationships in family interactions (letting go of guilt and anger, acceptance skills in relationships).
    5. Communication skills and effective self-expression, such as validation.
    6. Problem management and making safe plans for crisis management.
    7. Making new sense of my relationship with my family member, an opportunity to grow together.

    All the modules include practice exercises, video viewing, and homework assignment.

  • Optimized Treatment As UsualBehavioural

    Family members with this condition will continue to receive the usual treatment provided by their referral care center. In addition, we will optimize the treatment, following the recommendations of the international guidelines for the treatment of ED (NICE, 2017). There will be 3 two-hour session in group format each week, with the following components: Up-to-date information and research on ED and PD; Psychoeducation on the development of ED and PD; Explanatory theories; Available treatments and comorbidity.

    In both conditions, after each face-to-face session, the participant will be asked to review the contents addressed during the session as homework (independently of the homework corresponding to the specific module being addressed). All interventions carried out with family members will be performed by clinical psychologists or general health psychologists with at least a master's degree or a doctoral degree and previous training in the application of the programs.

Study groups in NCT05404035
Study groupRoleWhat they receive
Family Connections for relatives of people with eating disorders and personality disordersExperimentalThe intervention lasts 3 months and includes 14 two-hour sessions with a group format on a weekly basis. The FC program is divided into 7 modules: 2 of Psychoeducation (ED and PD criteria, explanatory theories, available treatments, comorbidity with PD, etc.) and 5 modules of Dialectical Behavioral Therapy skills training (Relationship mindfulness, effective communication, aceptation, validation, problem management and meaning of life).
Receives: Behavioral: Family Connections for relatives of people with eating disorders and personality disorders
Optimized Treatment As UsualActive comparatorFamily members with this condition will continue to receive the usual treatment provided by their referral care center. In addition, we will optimize the treatment, with 3 two-hour psychoeducation sessions in group format each week (ED and PD, explanatory theories, available treatments, comorbidity with PD).
Receives: Behavioral: Optimized Treatment As Usual

What is being measured

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

  1. Record of critical family-patient incidents

    Number of Binge eating and vomiting episodes (purging) in the past 3 months, Number of serious arguments between patient and caregivers in the past 3 months, Number of days of self-injury in the past 3 months, Number of episodes of verbal/physical violence with caregivers in the past 3 months; Number of visits to psychiatric emergency department in the past 3 months, Number of unscheduled therapy sessions held in the past 3 months (face-to-face, phone calls, etc.).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  2. Burden Assessment Scale (BAS)

    It is a 19-item scale that assesses the caregiver's objective and subjective burden due to the illness of his/her loved one within the past six months using a 4-point Likert scale ranging from 1 (nothing) to 4 (a lot). Total scores indicate that higher values mean stronger burden. The scale shows adequate validity and reliability (Cronbach's alpha ranges from .89 to .91) (Reinhard, Gubman, Horwitz \& Minsky, 1994).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Secondary outcomes (7)

  1. The Eating Disorder Symptom Impact Scale (EDSIS)

    It is a 24-item scale to assess eating disorder-specific caregiving experiences using a 5-point Likert-type scale from 0 (Never) to 4 (Nearly Always). The internal consistency is good, with Cronbach's alpha coefficients mostly above .70.

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  2. Family Assessment Device - Global Functioning Scale

    It is a 60-item self-report about family functioning in terms of 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 (Completely Agree) to 4 (Strongly Disagree). The internal consistency is good (Cronbach's alphas between .72 and .83) for the subscales, with a Cronbach's alpha of .92 for general functioning.

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  3. Mastery and Empowerment Scale (MES)

    It is a 34-item scale divided into three domains: family, service system, and involvement in community. Items are rated on a 5-point Likert scale ranging from 1 (Completely False) to 5 (Completely True). Different studies have demonstrated that the psychometric properties of the FES are robust in both the original and translated versions (Koren et al., 1992; Singhet al., 1995; Itzhaky \& Schwartz, 2001; Vuorenmaa et al., 2014).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  4. Multicultural Quality of Life Index (MQLI)

    The Multicultural Quality of Life Index is a culture-informed and self-rated instrument. Its 10 items cover key aspects of the concept, from physical well-being to spiritual fulfilment. Regarding its applicability, mean completion time was less than 3 minutes, and 96% of raters found it easy to use. Test-retest reliability was high (r=0.87). A Cronbach's alpha of 0.92 documented its internal consistency, and a factor analysis revealed a strong structure.

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  5. The Multidimensional Existential Meaning Scale (MEMS)

    It is a 15-item scale that assesses existential meaning through three dimensions: comprehension, purpose, and mattering. Items are rated on a 7-point Likert scale ranging from 1 (Very strongly disagree) to 7 (Very strongly agree). The three MEMS subscales showed adequate internal consistency: Comprehension (ω¯ = 91), Purpose (ω¯ = 92), and Mattering (ω¯ = 86).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  6. Depression, Anxiety and Stress Scale (DASS-21).

    It is a 21-item scale in its short version that measures clinical symptoms such as depression, anxiety, and stress. 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). It shows excellent internal consistency: depression (α = .94), anxiety (α = .87), and stress (α= .91).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

  7. Difficulties in Emotion Regulation Scale (DERS)

    In its adaptation, the authors reduced the items from 36 to 28, and they considered 5 scales instead 6. The subscales are: lack of emotional control, vital interference, lack of emotional attention, emotional confusion, and emotional rejection. Items are rated on a Likert-type scale ranging from 1 to 5 (1 = "Almost never" and 5 "Almost always"). Higher scores indicate greater difficulties with emotional regulation. Psychometric properties were adequate, with very good internal consistency (α = .93) and good test-retest reliability (pl = .74, p < .001).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up

Timeline

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

  1. First posted3 Jun 2022
  2. Study start23 May 2022
  3. Primary completion13 Sep 2023
  4. Study completion20 Nov 2024

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 Control Trial, Efficacy Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404035
Sponsor's protocol ID
UV-1955599
Other IDs
Research proyect
Acronym
FC-ED&PD
Status last verified
May 2026
First submitted
23 May 2022
Last updated
28 May 2026
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 de-identification. Supporting Information:

Publications

  • 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

  • Dimitropoulos G, Landers A, Freeman V, Novick J, Schmidt U, Olmsted M. A feasibility study comparing a web-based intervention to a workshop intervention for caregivers of adults with eating disorders. Eur Eat Disord Rev. 2019 Nov;27(6):641-654. doi: 10.1002/erv.2678. Epub 2019 May 7.

    PubMed 31063264

  • Gisladottir M, Treasure J, Svavarsdottir EK. Effectiveness of therapeutic conversation intervention among caregivers of people with eating disorders: quasi-experimental design. J Clin Nurs. 2017 Mar;26(5-6):735-750. doi: 10.1111/jocn.13412. Epub 2016 Dec 7.

    PubMed 27239974

  • Grover M, Williams C, Eisler I, Fairbairn P, McCloskey C, Smith G, Treasure J, Schmidt U. An off-line pilot evaluation of a web-based systemic cognitive-behavioral intervention for carers of people with anorexia nervosa. Int J Eat Disord. 2011 Dec;44(8):708-15. doi: 10.1002/eat.20871. Epub 2010 Nov 15.

    PubMed 22072408

  • 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

  • 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

  • Guillen V, Arnal A, Perez S, Garcia-Alandete J, Fernandez-Felipe I, Grau A, Botella C, Marco JH. Family connections in the treatment of relatives of people with eating disorders and personality disorders: study protocol of a randomized control trial. BMC Psychol. 2023 Mar 30;11(1):88. doi: 10.1186/s40359-023-01138-x.

    PubMed 36998024

Questions about this trial

What is this clinical trial studying?

A study testing Family Connections for relatives of people with eating disorders and personality disorders and Optimized Treatment As Usual in people with Relatives, run by University of Valencia 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 1 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: finished, as of the sponsor's last update on 28 May 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Record of critical family-patient incidents (time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-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 NCT05404035, 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 28 May 2026.

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