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

NCT05404035 | Unknown DMC

• 1 other identifier: UV-1955599
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Relatives

Keywords

Intervention; family members; caregivers; eating disorders; personality disorders

Outcome Measures

Primary Outcomes (2)

• 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.).

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

• 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).

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

Secondary Outcomes (7)

• The Eating Disorder Symptom Impact Scale (EDSIS)

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

• Family Assessment Device - Global Functioning Scale

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

• Mastery and Empowerment Scale (MES)

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

• Multicultural Quality of Life Index (MQLI)

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

• The Multidimensional Existential Meaning Scale (MEMS)

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

Other Outcomes (6)

• Opinion of treatment scale

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

• The Eating Attitudes Test-26 (EAT-26)

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

• Patient Health Questionnaire (PHQ-9)

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

Study Arms (2)

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

EXPERIMENTAL

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).

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

Optimized Treatment As Usual

ACTIVE COMPARATOR

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).

Behavioral: Optimized Treatment As Usual

Interventions

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

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

Optimized Treatment As Usual 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.

Optimized Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Universitat Jaume I: collaborator

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 16013747 RESULT

• 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.

  PMID: 31063264 RESULT

• 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.

  PMID: 27239974 RESULT

• 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.

  PMID: 22072408 RESULT

• 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.

  PMID: 17257517 RESULT

• 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.

  PMID: 28861273 RESULT

• 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.

  PMID: 36998024 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Personality Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Isabel Fernández-Felipe

  Universitat Jaume I de Castellón

  STUDY CHAIR

• Joaquín García-Alandete, Dr

  University of Valencia

  STUDY CHAIR

• Sandra Pérez, Dr

  University of Valencia

  STUDY CHAIR

• Sara Fonseca-Baeza

  University of Valencia

  STUDY CHAIR

• Azucena García Palacios, Dr

  Universitat Jaume I de Castellón

  STUDY CHAIR

• Rosa Baños, Dr.

  University of Valencia

  STUDY CHAIR

• Cristina Botella, Dr

  Universitat Jaume I de Castellón

  STUDY CHAIR

Central Study Contacts

Verónica Guillén, Dr

CONTACT

963864386; veronica.guillen@uv.es

José Marco, Dr

CONTACT

963864386; jose.h.marco@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial, Efficacy Study

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 3, 2022
• Study Start: May 23, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available immediately after publication
• Access Criteria: The data will be available to anyone who wishes to access them

Locations

ES (1)