Engaging Latino Families in Eating Disorders Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for BN, BED, EDNOS (sub-threshold BN)
- •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
排除标准
- •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.
结局指标
主要结局
Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment
时间窗: 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.
次要结局
- 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 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)
- Treatment Adherence as of End of Treatment(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 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)
- Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment(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)
- 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)
- Change from Baseline in Family Cohesion (FC) score at End of Treatment(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)
研究者
Mae Lynn Reyes-Rodriguez, PhD
Clinical Assistant Professor in Psychiatry
University of North Carolina, Chapel Hill