- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404035
"Family Connections" for Caregivers of People With Eating Disorders and Personality Disorders. (FC-ED&PD)
"Family Connections" an Intervention for Caregivers of People With Eating Disorders and Personality Disorders: Study Protocol for a Randomized Controlled Trial.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Verónica Guillén, Dr
- Phone Number: 4386 963864386
- Email: veronica.guillen@uv.es
Study Contact Backup
- Name: José Marco, Dr
- Phone Number: 4386 963864386
- Email: jose.h.marco@uv.es
Study Locations
-
-
-
Valencia, Spain, 46010
- Recruiting
- University of Valencia
-
Contact:
- Verónica Guillén
- Phone Number: 659387618
- Email: vguillenbotella@gmail.com
-
Principal Investigator:
- Verónica Guillén, Dr
-
Principal Investigator:
- Heliodoro Marco, Dr
-
Sub-Investigator:
- Joaquín García-Alandete, Dr
-
Sub-Investigator:
- Sandra Pérez, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
The FC program (Fruzzetti and Hoffman, 2005) is divided into 7 modules:
All the modules include practice exercises, video viewing, and homework assignment. |
Active Comparator: 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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Record of critical family-patient incidents
Time Frame: 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.).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Burden Assessment Scale (BAS)
Time Frame: 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).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Eating Disorder Symptom Impact Scale (EDSIS)
Time Frame: 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.
|
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
Time Frame: 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.
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Mastery and Empowerment Scale (MES)
Time Frame: 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).
|
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)
Time Frame: 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.
|
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)
Time Frame: 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).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Depression, Anxiety and Stress Scale (DASS-21).
Time Frame: 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).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 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).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opinion of treatment scale
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale was designed and developed by members of the research team and constructed from an adaptation of another opinion and expectations questionnaire.
The constructs this scale assesses are: opinion, acceptance and satisfaction with the skills training program, and the changes in the participants after the completion of each module.
The questions refer to the rationale for the intervention, recommending the program, satisfaction with the program, usefulness, and expectations of the skills training.
The items are rated on a Likert-type scale ranging from 0 "Not at all" to 10 "Very much".
|
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)
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale is used to evaluate the patients.
It is a 26-item self-report to assess attitudes toward eating.
Items are rated on a 6-point Likert scale ranging from 1 (Never) to 6 (Always).
The reliability analysis indicates good internal consistency Doninger, Enders, & Burnett, 2005; Garner etal., 1982; Jorquera, et al, 2006; Nunes, Camey, Olinto, &Mari, 2005; Pereira et al., 2008).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale is used to evaluate the patients.
It assesses each of the 9-DSM-IV criteria for depression in 9 items.
Items are rated on a 4-point Likert scale ranging from 0 (Not at all) to 3 (Nearly Every Day).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale is used to evaluate the patients.
It is a 5-item scale that assesses the severity and frequency of anxiety symptoms, behavioral avoidance, and the functional impairment related to anxiety.
Items are rated on a 4-point Likert scale ranging from 0 to 4. The scale shows good psychometric properties such as test-retest reliability and internal consistency (α =.80).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Validating and Invalidating Responses Scale (VIRS).
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale is used to evaluate the patients.
It is a 16-item scale that assesses the levels of perceived validation and invalidation of caregivers' responses, divided into validating and invalidating responses.
Items are rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Almost Always).
Higher scores signify greater perceived validation or invalidation of the responses of the caregiver being assessed.
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Lum Emotional Availability of Parents (LEAP).
Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
This scale is used to evaluate the patients.
It is a 15-item questionnaire that assesses the emotional availability of mothers and fathers as perceived by the person assessing their relatives.
Items are rated on a 6-point Likert scale ranging from 1 (Never) to 6 (Always).
The psychometric properties are very good, such that, in a clinical sample, excellent internal consistency is observed (for the mother α = .92,
and for the father α = .93).
In addition, it has adequate test-retest reliability for the mother's form (r = .92)
and the father's form (r = .85).
|
Changes will be assessed from pre-treatment to immediately after the intervention, and also at 12-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UV-1955599
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relatives
-
University of Southern DenmarkOdense University HospitalCompletedCancer | Rehabilitation | RelativesDenmark
-
University of ValenciaUniversitat Jaume IActive, not recruiting
-
University of ZurichUnknownPsychological Distress | Relatives | PolytraumaSwitzerland
-
University Hospital, BordeauxCompletedTransmission of Information to the Relatives After Genetic DiagnosisFrance
-
Holbaek SygehusRigshospitalet, Denmark; Herlev Hospital; Svendborg Hospital; Naestved Hospital; Nykøbing... and other collaboratorsCompletedRelatives | Intensive Care Unit SyndromeDenmark
-
University Hospital, LilleCompletedSuicide, Attempted | RelativesFrance
-
University Hospital, CaenUnknownPatients With Total Laryngectomy and Their Close Relatives
-
Universitat Jaume IUniversity of ValenciaNot yet recruiting
-
Universitat Jaume IUniversity of ValenciaUnknown
-
Hvidovre University HospitalUniversity of Aarhus; Danish Lung AssociationRecruitingRelatives | Physical Inactivity | Nutrition Poor | COPD Exacerbation AcuteDenmark
Clinical Trials on Family Connections for relatives of people with eating disorders and personality disorders
-
Suzanne HaeyenUniversity of TwenteRecruiting
-
University of ValenciaUniversitat Jaume IActive, not recruiting
-
University of Sao PauloUnknown
-
University of South FloridaUniversity of MiamiUnknownMisophoniaUnited States
-
All India Institute of Medical Sciences, New DelhiCompletedPrecancerous ConditionsIndia
-
Ohio State UniversityChildren's Bureau - Administration for Children and Families; Pickaway County... and other collaboratorsCompletedChild Abuse | Substance Use | Substance Abuse | Neglect, ChildUnited States
-
University of California, RiversideRecruitingOpioid-use DisorderUnited States
-
University Hospital, RouenUnknown
-
Hadassah Medical OrganizationUnknown
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; National Institute of Chemistry... and other collaboratorsCompletedCTNNB1 Gene MutationSlovenia, Australia