NCT05404035

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-06-03
• Last updated: 2022-06-03

Locations

1 site across 1 country: Spain