Engaging Latino Families in Eating Disorders Treatment
- Conditions
- Binge Eating DisorderEating Disorder Not Otherwise SpecifiedBulimia Nervosa
- Interventions
- Behavioral: Cognitive Behavioral Therapy with Family EnhancementBehavioral: Cognitive Behavioral Therapy
- Registration Number
- NCT01470508
- Lead Sponsor
- Mae Lynn Reyes-Rodriguez, PhD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Family Enhancement Cognitive Behavioral Therapy with 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. Cognitive Behavioral Therapy 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment 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 Baseline, 3 Month Follow-up Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up Baseline, 3 Month Follow-up Change from Baseline in Family Score (FS) at 3 Month Follow-up Baseline, 3 Month Follow-up Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up Baseline, 3 Month Followup Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment 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.
Treatment Adherence as of End of Treatment 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 Baseline, Week 6 Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up Baseline, 3 Month Follow-up Change from Baseline in Family Support Questionnaire score at End of Treatment 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 End of Treatment 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 Baseline, 3 Month Follow-up Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment Baseline, Week 6 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 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 End of Treatment 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 Baseline, 3 Month Follow-up Change from Baseline in Family Score (FS) at End of Treatment Baseline, End of Treatment
Trial Locations
- Locations (2)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
UNC Center of Excellence for Eating Disorders
🇺🇸Chapel Hill, North Carolina, United States