Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
研究概览
简要总结
The goal of the study is to evaluate two 6-month adjunct interventions (peer mentorship and social support mentorship) for individuals with eating disorders. Individuals will be randomized to peer-mentorship, social support mentorship, or a wait-list and eating disorder symptoms will be evaluated at baseline and post-treatment.
详细描述
Eating disorders are serious mental illnesses associated with significant morbidity and high relapse rates. Patients are at especially high risk of relapse after leaving structured treatment (e.g., hospitalization). Adjunct interventions targeting patients' motivation and participation in treatment at these times may help patients recover from eating disorders. Project HEAL is a non-profit organization whose mission is to reduce suffering caused by eating disorders, and they have recently developed two adjunct, mentorship-based interventions for patients in recovery. In the peer mentorship condition, individuals meet weekly with a peer mentor who has previously recovered from an eating disorder in order to discuss symptoms and coping strategies. In the social support mentorship condition, individuals meet weekly with a social support mentor who has not personally struggled with an eating disorder in order to engage in activities unrelated to the eating disorder. The aim of the current study is to evaluate the feasibility and efficacy of this intervention. The design of the study is a three-arm randomized controlled trial comparing peer mentorship, social-support mentorship, and wait-list control conditions. Participants in the study will be randomized to one of the three conditions for six months. Wait-list participants will subsequently receive either type of mentorship. Participants will complete assessments of their eating disorder symptoms at baseline, monthly throughout the course of the study, and one year after beginning the study. Outcomes will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Since this is a behavioral intervention, participants, care providers, and investigators are aware of each patient's randomization. Outcomes are assessed electronically.
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or past 6 months AN, BN, or BED
- •Recent (within 6 months) discharge from structured treatment
- •Involved in outpatient treatment at an appropriate level of care
- •Medical stability
- •Access to smart phone or computer to complete study assessments
排除标准
- •Evidence of needing specialized treatment for another medical or mental health condition
结局指标
主要结局
Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
时间窗: Baseline, Month 3, Month 6
The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Cognitive Restraint subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Cognitive Restraint is 0 - 12. Higher scores are reflective of greater eating pathology.
Body Mass Index
时间窗: Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
kg/m2
Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
时间窗: Baseline, Month 3, Month 6
The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Body Dissatisfaction subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Body dissatisfaction is 0 - 28. Higher scores are reflective of greater eating pathology.
Binge Days
时间窗: Baseline through Week 28
Units on a scale from 0 - 4 ( 0 = 0 days; 1 = A few (1-2) days; 2 = About half (3-4) days; 4 = Most (5-6) days; 4 = All (7) days Range was 0 - 4
Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
时间窗: Baseline, Month 3, Month 6
The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Restricting subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Restricting is 0 - 24. Higher scores are reflective of greater eating pathology.
次要结局
未报告次要终点
研究者
Lisa Ranzenhofer
Assistant Professor of Clinical Psychology (in Psychiatry)
New York State Psychiatric Institute