Engaging Latino Families in Eating Disorders Treatment

Study Overview
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Brief Summary
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Promoviendo Alimentacion Saludable (PAS)Promoting Healthy Eating is a research project funded by the National Institute of Mental Health. The purpose of this study is to develop and test a treatment for eating disorders in Latina adults that is appropriate for their age and includes culturally appropriate family intervention.

Detailed Description
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Research on culturally sensitive assessment and treatment of eating disorders among Latinos is scarce. This study is comparing individual Cognitive Behavioral Therapy (CBT) versus CBT with a family adjunctive intervention for eating disorders in Latina adults. All treatment will be conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or from El Futuro, Inc. (in Carrboro or Durham, NC) who have been trained in the treatment of eating disorders. Participants will participate in 25, 50 minute-long, face-to-face CBT sessions over 27 weeks. Participants will be randomly placed in one of two groups: CBT or CBT with family enhancement. Those participants who are randomly placed into the CBT group will participate in 25 individual therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. Those participants who have been randomly placed into the CBT with family enhancement group will participate in 19 individual therapy sessions, 6 family therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. All participants will also be expected to participate in baseline, week 6 (mid-treatment), end of treatment, and 3-month follow-up assessments.

Official Title
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Engaging Latino Families in Eating Disorders Treatment

Conditions
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Bulimia Nervosa, Binge Eating Disorder, Eating Disorder Not Otherwise Specified

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Cognitive Behavioral Therapy with Family Enhancement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV criteria for BN, BED, EDNOS (sub-threshold BN) Latina If taking antidepressant medication, stable dose for at least 3 months prior Willingness to ask a family member or significant other to participate AND agreement of family member to participate Exclusion Criteria: Any major medical condition that would interfere with treatment or require alternative treatment Alcohol or drug dependence in the last three months Current significant suicidal ideation Developmental disability that would impair the ability of the participant to benefit from psychotherapy effectively Psychosis, including schizophrenia, or bipolar I disorder Pregnancy Body mass index below 17.5 kg/m^2 If taking antidepressant medication, doses are not stable; individuals taking any medications that can significantly affect appetite or weight.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Enhancement<br>PAS is a 27-week program consisting of 25 sessions, 50 minutes in length, between an individual and a therapist. During six (6) family sessions, a family member will accompany the individual to therapy and will take an active role during the session. In this program, individuals and their family members will learn about ways to communicate about their relationship in the context of experiencing an eating disorder. PAS focuses on family-specific skills such as communication skills and problem solving skills while also incorporating eating disorders psychoeducation. | Behavioral: Cognitive Behavioral Therapy with Family Enhancement<br>* Individuals will meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy with Family Enhancement is manualized and will involve the participation of family members during six (6) weeks of treatment.<br>* Other names: PAS;|
| Active Comparator: Cognitive Behavioral Therapy<br>Individuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. | Behavioral: Cognitive Behavioral Therapy<br>* Individuals meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy is manualized and is the standard form of care at the UNC Eating Disorders Program.<br>* Other names: Eating disorder treatment as usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment |  | Baseline, Week 6 | 
| Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 
| Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment |  | Baseline, Week 6 of Treatment | 
| Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 
| Change from Baseline in Family Support Questionnaire score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up |  | Baseline, 3 Month Followup | 
| Change from Baseline in Family Cohesion (FC) score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 
| Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 
| Change from Baseline in Family Score (FS) at End of Treatment |  | Baseline, End of Treatment | 
| Change from Baseline in Family Score (FS) at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 
| Treatment Adherence as of End of Treatment | Treatment Adherence will be measured positively if a participant has completed at least 80% of treatment (20 sessions or more) or negatively if less than 80% of treatment (19 sessions or less) has been completed. | Baseline, End of Treatment | 
| Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment |  | Baseline, Week 6 | 
| Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. | Baseline, End of Treatment | 
| Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up |  | Baseline, 3 Month Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulimia, Binge-Eating Disorder, Eating Disorders