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Engaging Latino Families in Eating Disorders Treatment (PAS)

This study is currently recruiting participants.
Verified May 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
El Futuro, Inc.
Information provided by (Responsible Party):
Mae Lynn Reyes-Rodriguez, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01470508
First received: November 9, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Bulimia Nervosa
Binge Eating Disorder
Eating Disorder Not Otherwise Specified
 Behavioral: Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy with Family Enhancement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Engaging Latino Families in Eating Disorders Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.


Secondary Outcome Measures:
  • Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 of Treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Family Support Questionnaire score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Followup ] [ Designated as safety issue: No ]
  • Change from Baseline in Family Cohesion (FC) score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Family Score (FS) at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Family Score (FS) at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]
  • Treatment Adherence as of End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    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.

  • Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  • Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470508

Contacts
Contact: Mae Lynn Reyes-Rodriguez, PhD (919) 966-7358 maelynn_reyes@med.unc.edu

Locations
United States, North Carolina
UNC Center of Excellence for Eating Disorders Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mae Lynn Reyes-Rodriguez, PhD     919-966-7358     maelynn_reyes@med.unc.edu    
Principal Investigator: Mae Lynn Reyes-Rodriguez, PhD            
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7160
Contact: Mae Lynn Reyes-Rodriguez, PhD     919-966-7358     maelynn_reyes@med.unc.edu    
Principal Investigator: Mae Lynn Reyes-Rodriguez, PhD            
Sponsors and Collaborators
Mae Lynn Reyes-Rodriguez, PhD
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
El Futuro, Inc.
Investigators
Principal Investigator: Mae Lynn Reyes-Rodriguez, PhD University of North Carolina, Chapel Hill
  More Information

Additional Information:
For more information about PAS, please click here.  This link exits the ClinicalTrials.gov site

No publications provided

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, K-23-MH087954-01A1
Study First Received: November 9, 2011
Last Updated: May 6, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Bulimia
Binge-Eating Disorder
Eating Disorders

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Bulimia Nervosa
 Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013