Clinical trial NCT01470508: Engaging Latino Families in Eating Disorders Treatment
Official title: Engaging Latino Families in Eating Disorders Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Binge Eating Disorder
Eating Disorder Not Otherwise Specified
Keywords: Bulimia
Binge-Eating Disorder
Eating Disorders
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Institute of Mental Health (NIMH)
name: El Futuro
First posted: 2011-11-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment
timeFrame: Baseline, End of Treatment
Secondary outcomes:
measure: Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment
timeFrame: Baseline, Week 6
measure: Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
measure: Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment
timeFrame: Baseline, Week 6 of Treatment
measure: Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
measure: Change from Baseline in Family Support Questionnaire score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Followup
measure: Change from Baseline in Family Cohesion (FC) score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
measure: Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
measure: Change from Baseline in Family Score (FS) at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Family Score (FS) at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
measure: Treatment Adherence as of End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment
timeFrame: Baseline, Week 6
measure: Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment
timeFrame: Baseline, End of Treatment
measure: Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up
timeFrame: Baseline, 3 Month Follow-up
Other outcomes:
measure: M-FED Questionnaire
timeFrame: 3 Month Follow-up
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Center of Excellence for Eating Disorders
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mae Lynn Reyes-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: