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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 10-0773 | Other Identifier | University of North Carolina Institutional Review Board | |
| K-23-MH087954-01A1 | Other Grant/Funding Number | NIMH |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| El Futuro | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Enhancement | Experimental | 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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| Cognitive Behavioral Therapy | Active Comparator | Individuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| M-FED Questionnaire | 3 Month Follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mae Lynn Reyes-Rodriguez, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599-7160 | United States | ||
| UNC Center of Excellence for Eating Disorders |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D056912 | Binge-Eating Disorder |
| D002032 | Bulimia |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavioral Therapy with Family Enhancement | Behavioral | 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. |
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| 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 | 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 |
| 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 | 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 |
| Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up | Baseline, 3 Month Followup |
| 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 |
| Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up | Baseline, 3 Month Follow-up |
| 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 |
| 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 |
| Change from Baseline in Family Score (FS) at 3 Month Follow-up | Baseline, 3 Month Follow-up |
| 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 |
| Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment | Baseline, Week 6 |
| 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 |
| Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up | Baseline, 3 Month Follow-up |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |