Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Changes in Eating Disorder Severity (assessor-based)
研究概览
简要总结
Inpatient treatment for patients with anorexia nervosa (AN) is recommended in extreme or severe cases after failure of outpatient treatment and is highly effective. However, a number of patients show symptom increase and relapse after discharge. The aim of this study is to evaluate the efficacy of a guided smartphone-based aftercare intervention following inpatient treatment of patients with AN to support symptom stabilization or continued improvement.
详细描述
Anorexia nervosa (AN) is a severe, often chronic and life-threatening disorder. Relapse after treatment is common with relapse rates ranging between 9 and 52% and being highest within the first year following treatment particularly as early as 3 months posttreatment. Even if weight restoration is achieved, it is quite difficult for patients to sustain improvements after treatment, so aftercare and relapse prevention are essential research topics. There is a recent review on internet- and mobile-based aftercare and relapse prevention in mental disorders that concludes that there is some evidence that such interventions are feasible instruments for maintaining treatment gains for some mental disorders, including eating disorders (EDs). However, the authors claim for further high quality, large-scale trials that are needed to expand research fields. So, the aim of this study is to prove the efficacy of a guided smartphone-based aftercare intervention for inpatients with AN. Our primary hypothesis is that at the end of aftercare intervention (T1), the intervention group shows a significantly lower eating disorder symptomatology than the control group.
Eligible patients with AN who are discharged from inpatient treatment are randomized either to receive a 4-month smartphone-based aftercare intervention with therapist feedback as an add-on element to treatment as usual (TAU) or TAU alone. Assessments include structured interviews as well as online questionnaires and are taken at baseline (discharge, T0), end of the aftercare intervention (T1) as well as 6-month follow-up (T2).
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of AN (DSM-5: 307.1),
- •sex: female,
- •age: from 12 years onwards to 60 years,
- •regular completion of inpatient treatment,
- •at least a length of inpatient stay of 6 weeks,
- •BMI at discharge at least 15, at least a 1-point BMI increase during inpatient treatment,
- •owner of a smartphone,
- •informed consent of the patient and, in case of minors, also of the parents.
排除标准
- •major depression (BDI-II > 29 at discharge),
- •suicidal tendency (item 9 of BDI-II > 1 at discharge),
- •very high level of care after inpatient treatment (e.g. therapeutic living community, day clinic),
- •pregnancy.
结局指标
主要结局
Changes in Eating Disorder Severity (assessor-based)
时间窗: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
The Eating Disorder Examination (EDE) will be used to measure asessor-based eating disorder symptom severity over time.
次要结局
- Additional outpatient and inpatient treatment after discharge(Measured at week 16 and 6 month follow-up)
- Adherence to the smartphone-based aftercare intervention(Measured from baseline to week 16)
- Changes in Eating Disorder Severity (self-report)(Measured at baseline, week 16 and 6 month follow-up)
- Changes in Body-Mass-Index (BMI)(Measured at baseline, week 16 and 6 month follow-up)
- Changes in depressive symptoms(Measured at baseline, week 16 and 6 month follow-up)
- Changes in stages of change regarding specific eating disorder behaviors(Measured at baseline, week 16 and 6 month follow-up)
- Changes in self-efficay(Measured at baseline, week 16 and 6 month follow-up)
- Participant satisfaction with the app and the aftercare intervention(Measured at week 16)
- Adherence to self-monitoring tasks(Measured from baseline to week 16)
研究者
Schlegl Sandra
Principal Investigator
Ludwig-Maximilians - University of Munich