Engaging Latino Families in Eating Disorders Treatment (PAS)
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ClinicalTrials.gov Identifier: NCT01470508 |
Recruitment Status
:
Completed
First Posted
: November 11, 2011
Last Update Posted
: May 18, 2016
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Condition or disease | Intervention/treatment | Phase |
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Bulimia Nervosa Binge Eating Disorder Eating Disorder Not Otherwise Specified | Behavioral: Cognitive Behavioral Therapy Behavioral: Cognitive Behavioral Therapy with Family Enhancement | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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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.
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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
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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.
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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
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- 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.
- Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ]
- 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.
- Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 of Treatment ]
- 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.
- Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- 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.
- Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Followup ]
- 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.
- Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- 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.
- Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- Change from Baseline in Family Score (FS) at End of Treatment [ Time Frame: Baseline, End of Treatment ]
- Change from Baseline in Family Score (FS) at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- 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.
- Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment [ Time Frame: Baseline, Week 6 ]
- 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.
- Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up [ Time Frame: Baseline, 3 Month Follow-up ]
- M-FED Questionnaire [ Time Frame: 3 Month Follow-up ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470508
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 |
Principal Investigator: | Mae Lynn Reyes-Rodriguez, PhD | University of North Carolina, Chapel Hill |
Additional Information:
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 Key Record Dates |
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 |