A Study of the Feasibility and Effectiveness of the Addition of Self Help And Recovery Guide for Eating Disorders (SHARED) to Treatment as Usual for Anorexia Nervosa
试验速览
- 阶段
- 1 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in body weight at the end of the intervention
研究概览
简要总结
The aim of this study is to test a novel guided self-help intervention for patients with Anorexia Nervosa. The 6-week intervention includes the use of self-help materials (i.e. a workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person recovered from Anorexia Nervosa). Self-reports will be completed at baseline, end of 6 weeks, and 6- and 12 months follow-up. Participants interested in taking part will be randomly allocated to one of two groups.
详细描述
This trial investigates whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual (TAU) for individuals with anorexia nervosa (AN). Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with AN and targets the maintenance factors identified by the cognitive-interpersonal model of the illness.
Patients accessing outpatient services for AN are randomised to either TAU or TAU plus Recovery MANTRA. Outcomes variables include changes in body weight at the end of the intervention (primary) and changes in body weight and eating disorder symptoms at immediate and extended follow-ups (6-months and 12-months; secondary). Change is also assessed for the domains identified by the theoretical model, including, motivation, hope, confidence to change, positive mood, cognitive flexibility, therapeutic alliance and social adjustment. Feedback from peer mentors is gathered to understand the impact of providing guidance on their own well-being.
Results from this exploratory investigation will determine whether a larger clinical trial is justifiable and feasible for this affordable intervention which has potential for high reach and scalability.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral to one of the participating specialist adult outpatient eating disorder clinics with a primary DSM-5 diagnosis of Anorexia Nervosa or OSFED (Other Specified Feeding or Eating Disorder) with a body mass index (BMI; kg/m2) of 18.5 or below. OSFED will be defined as having features of Anorexia but missing at least two of the four diagnostic criteria.
排除标准
- •Insufficient knowledge of English
- •Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus).
研究组 & 干预措施
Intervention
Participants in this condition will receive the guided self-help intervention.
干预措施: Treatment as usual + Recovery MANTRA (Other)
Control
Participants in this condition will not receive the guided self-help intervention. They will receive treatment as usual and weekly feedback on their eating disorder symptoms for a period of 6 weeks.
干预措施: Treatment as usual + feedback (Other)
结局指标
主要结局
Changes in body weight at the end of the intervention
时间窗: 3 years
次要结局
- Changes in eating disorder symptoms at the end of the intervention and follow-up(3 years)