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

NCT ID: NCT05404035

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

The 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).

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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 Usual

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, with 3 two-hour psychoeducation sessions in group format each week (ED and PD, explanatory theories, available treatments, comorbidity with PD).

Group Type: ACTIVE_COMPARATOR

Optimized Treatment As Usual

Intervention Type: BEHAVIORAL

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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Optimized Treatment As Usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Jaume I

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabel Fernández-Felipe

Role: STUDY_CHAIR

Universitat Jaume I de Castellón

Joaquín García-Alandete, Dr

Role: STUDY_CHAIR

University of Valencia

Sandra Pérez, Dr

Role: STUDY_CHAIR

University of Valencia

Sara Fonseca-Baeza

Role: STUDY_CHAIR

University of Valencia

Azucena García Palacios, Dr

Role: STUDY_CHAIR

Universitat Jaume I de Castellón

Rosa Baños, Dr.

Role: STUDY_CHAIR

University of Valencia

Cristina Botella, Dr

Role: STUDY_CHAIR

Universitat Jaume I de Castellón

Locations

University of Valencia

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Verónica Guillén, Dr

Role: CONTACT

veronica.guillen@uv.es

963864386 ext. 4386

José Marco, Dr

Role: CONTACT

jose.h.marco@uv.es

963864386 ext. 4386

Facility Contacts

Verónica Guillén

Role: primary

vguillenbotella@gmail.com

659387618

References

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.

Reference Type: RESULT

PMID: 16013747 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31063264 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27239974 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22072408 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17257517 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28861273 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36998024 (View on PubMed)

Other Identifiers

UV-1955599

Identifier Type: -

Identifier Source: org_study_id