"Family Connections" for Caregivers of People With Eating Disorders and Personality Disorders.
- Conditions
- Relatives
- Interventions
- Behavioral: Optimized Treatment As UsualBehavioral: Family Connections for relatives of people with eating disorders and personality disorders
- Registration Number
- NCT05404035
- Lead Sponsor
- University of Valencia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimized Treatment As Usual 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). Family Connections for relatives of people with eating disorders and personality disorders 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).
- Primary Outcome Measures
Name Time Method Record of critical family-patient incidents Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up 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.).
Burden Assessment Scale (BAS) Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up 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).
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
Mastery and Empowerment Scale (MES) Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up 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).
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 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).
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 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.
Depression, Anxiety and Stress Scale (DASS-21). Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up 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).
Difficulties in Emotion Regulation Scale (DERS) Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up 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).
Trial Locations
- Locations (1)
University of Valencia
🇪🇸Valencia, Spain