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Engaging Latino Families in Eating Disorders Treatment (PAS)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy with Family Enhancement
Sponsored by
Mae Lynn Reyes-Rodriguez, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia, Binge-Eating Disorder, Eating Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina
  • UNC Center of Excellence for Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Enhancement

Cognitive Behavioral Therapy

Arm Description

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.

Individuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment
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.
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up
Change from Baseline in the Symptom Checklist-36 (SCL-36) score at 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.
Change from Baseline in Symptom Checklist-36 (SCL-36) score at 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.
Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up
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.
Change from Baseline in Family Cohesion (FC) score at 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.
Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up
Change from Baseline in Family Score (FS) at End of Treatment
Change from Baseline in Family Score (FS) at 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.
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment
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.
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up

Full Information

First Posted
November 9, 2011
Last Updated
May 16, 2016
Sponsor
Mae Lynn Reyes-Rodriguez, PhD
Collaborators
University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH), El Futuro
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1. Study Identification

Unique Protocol Identification Number
NCT01470508
Brief Title
Engaging Latino Families in Eating Disorders Treatment
Acronym
PAS
Official Title
Engaging Latino Families in Eating Disorders Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mae Lynn Reyes-Rodriguez, PhD
Collaborators
University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH), El Futuro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge Eating Disorder, Eating Disorder Not Otherwise Specified
Keywords
Bulimia, Binge-Eating Disorder, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Individuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
Eating disorder treatment as usual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy with Family Enhancement
Other Intervention Name(s)
PAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Secondary Outcome Measure Information:
Title
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment
Time Frame
Baseline, Week 6
Title
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Title
Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment
Time Frame
Baseline, Week 6 of Treatment
Title
Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Title
Change from Baseline in Family Support Questionnaire score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Followup
Title
Change from Baseline in Family Cohesion (FC) score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Title
Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Title
Change from Baseline in Family Score (FS) at End of Treatment
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Family Score (FS) at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Title
Treatment Adherence as of End of Treatment
Description
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.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment
Time Frame
Baseline, Week 6
Title
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment
Description
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Time Frame
Baseline, End of Treatment
Title
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up
Time Frame
Baseline, 3 Month Follow-up
Other Pre-specified Outcome Measures:
Title
M-FED Questionnaire
Time Frame
3 Month Follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mae Lynn Reyes-Rodriguez, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7160
Country
United States
Facility Name
UNC Center of Excellence for Eating Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Engaging Latino Families in Eating Disorders Treatment

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