Engaging Latino Families in Eating Disorders Treatment
PAS
3 other identifiers
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMay 18, 2016
May 1, 2016
5.6 years
November 9, 2011
May 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
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
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
Baseline, End of Treatment
- +13 more secondary outcomes
Other Outcomes (1)
M-FED Questionnaire
3 Month Follow-up
Study Arms (2)
Family Enhancement
EXPERIMENTALPAS 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.
Cognitive Behavioral Therapy
ACTIVE COMPARATORIndividuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mae Lynn Reyes-Rodriguez, PhDlead
- University of North Carolina, Chapel Hillcollaborator
- National Institute of Mental Health (NIMH)collaborator
- El Futurocollaborator
Study Sites (2)
University of North Carolina
Chapel Hill, North Carolina, 27599-7160, United States
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mae Lynn Reyes-Rodriguez, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor in Psychiatry
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
August 1, 2010
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 18, 2016
Record last verified: 2016-05