Clinical trial NCT05404035: "Family Connections" for Caregivers of People With Eating Disorders and Personality Disorders.
Official title: "Family Connections" an Intervention for Caregivers of People With Eating Disorders and Personality Disorders: Study Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relatives
Keywords: Intervention
family members
caregivers
eating disorders
personality disorders
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Universitat Jaume I
First posted: 2022-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial, Efficacy Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Record of critical family-patient incidents
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Burden Assessment Scale (BAS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Secondary outcomes:
measure: The Eating Disorder Symptom Impact Scale (EDSIS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Family Assessment Device - Global Functioning Scale
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Mastery and Empowerment Scale (MES)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Multicultural Quality of Life Index (MQLI)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: The Multidimensional Existential Meaning Scale (MEMS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Depression, Anxiety and Stress Scale (DASS-21).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Other outcomes:
measure: Opinion of treatment scale
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: The Eating Attitudes Test-26 (EAT-26)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Validating and Invalidating Responses Scale (VIRS).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
measure: Lum Emotional Availability of Parents (LEAP).
timeFrame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Universitat Jaume I de Castellón
name: Isabel Fernández-Felipe
role: STUDY_CHAIR
affiliation: University of Valencia
name: Joaquín García-Alandete, Dr
role: STUDY_CHAIR
affiliation: University of Valencia
name: Sandra Pérez, Dr
role: STUDY_CHAIR
affiliation: University of Valencia
name: Sara Fonseca-Baeza
role: STUDY_CHAIR
affiliation: Universitat Jaume I de Castellón
name: Azucena García Palacios, Dr
role: STUDY_CHAIR
affiliation: University of Valencia
name: Rosa Baños, Dr.
role: STUDY_CHAIR
affiliation: Universitat Jaume I de Castellón
name: Cristina Botella, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.