Engaging Latino Families in Eating Disorders Treatment

Bulimia Nervosa Clinical Trial

— PAS  

Official title:

Engaging Latino Families in Eating Disorders Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470508
• Other study ID #: 10-0773
• Secondary ID: IRB# 10-0773K-23
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: May 16, 2016
• Start date: August 2010
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorder Not Otherwise Specified

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UNC Center of Excellence for Eating Disorders	Chapel Hill	North Carolina
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Mae Lynn Reyes-Rodriguez, PhD	El Futuro, National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	M-FED Questionnaire		3 Month Follow-up	No
Primary	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	No
Secondary	Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment		Baseline, Week 6	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up		Baseline, 3 Month Follow-up	No
Secondary	Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment		Baseline, Week 6 of Treatment	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up		Baseline, 3 Month Follow-up	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up		Baseline, 3 Month Followup	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up		Baseline, 3 Month Follow-up	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up		Baseline, 3 Month Follow-up	No
Secondary	Change from Baseline in Family Score (FS) at End of Treatment		Baseline, End of Treatment	No
Secondary	Change from Baseline in Family Score (FS) at 3 Month Follow-up		Baseline, 3 Month Follow-up	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment		Baseline, Week 6	No
Secondary	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.	Baseline, End of Treatment	No
Secondary	Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up		Baseline, 3 Month Follow-up	No

External Links

•   For more information about PAS, please click here.