Engaging Latino Families in Eating Disorders Treatment (PAS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Bulimia Nervosa; Binge Eating Disorder; Eating Disorder Not Otherwise Specified	Behavioral: Cognitive Behavioral Therapy; Behavioral: Cognitive Behavioral Therapy with Family Enhancement	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Engaging Latino Families in Eating Disorders Treatment
Study Start Date :	August 2010
Actual Primary Completion Date :	March 2016
Actual Study Completion Date :	March 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Family Enhancement; 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; 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.; Other Name: PAS
Active Comparator: Cognitive Behavioral Therapy; 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; 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.; Other Name: Eating disorder treatment as usual

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ]
2. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
   End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
3. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
4. Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 of Treatment ]
5. Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
   End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
6. Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
7. Change from Baseline in Family Support Questionnaire score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
   End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
8. Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Followup ]
9. Change from Baseline in Family Cohesion (FC) score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
   End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
10. Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
11. Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
12. Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
13. Change from Baseline in Family Score (FS) at End of Treatment [ Time Frame: Baseline, End of Treatment ]
14. Change from Baseline in Family Score (FS) at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
15. Treatment Adherence as of End of Treatment [ Time Frame: Baseline, 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.
16. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ]
17. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment [ Time Frame: Baseline, End of Treatment ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
18. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]

Other Outcome Measures:

1. M-FED Questionnaire [ Time Frame: 3 Month Follow-up ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7160
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

Mae Lynn Reyes-Rodriguez, PhD

University of North Carolina, Chapel Hill

National Institute of Mental Health (NIMH)

El Futuro

Investigators

Principal Investigator:	Mae Lynn Reyes-Rodriguez, PhD	University of North Carolina, Chapel Hill

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

For more information about PAS, please click here. 

Responsible Party:	Mae Lynn Reyes-Rodriguez, PhD, Clinical Assistant Professor in Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01470508 History of Changes
Other Study ID Numbers:	10-0773; IRB# 10-0773 ( Other Identifier: University of North Carolina Institutional Review Board ); K-23-MH087954-01A1 ( Other Grant/Funding Number: NIMH )
First Posted:	November 11, 2011
Last Update Posted:	May 18, 2016
Last Verified:	May 2016

Keywords provided by Mae Lynn Reyes-Rodriguez, PhD, University of North Carolina, Chapel Hill:

Bulimia; Binge-Eating Disorder; Eating Disorders

Additional relevant MeSH terms:

Disease; Feeding and Eating Disorders; Bulimia; Binge-Eating Disorder; Bulimia Nervosa	Pathologic Processes; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms