Efficacy of a Therapist-guided Smartphone-based Intervention to Support Recovery From Bulimia Nervosa: a Randomized Controlled Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 5
- 主要终点
- Changes in Eating Disorder Severity (assessor-based)
研究概览
简要总结
Inpatient treatment for patients with bulimia nervosa (BN) is recommended in extreme or severe cases and/or 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 BN to support recovery.
详细描述
Bulimia nervosa (BN) is a severe mental disorder characterized by recurrent episodes of binge eating and recurrent inappropriate compensatory behaviors to prevent weight gain. Evidence-based psychological treatments exist, however, even if treatment is successful in reducing behaviors such as binge eating and purging, abstinence rates may remain low and even if remission or abstinence have been received after treatment relapse rates are substantial. There is evidence that the stability of remission increases if the corresponding symptom improvement lasts at least for 4 months. Studies on the effectiveness of inpatient treatment in adult patients with BN show responder rates of up to 77%. However, it is often difficult for patients to maintain therapy success after discharge, as relapse rates reach up to 40% with the highest risk during the first 5 or 6 months after remission. There is preliminary evidence for efficacy regarding the potential of technology-based interventions in aftercare for patients with BN. However, so far, there is no study evaluating a smartphone-based aftercare intervention for patients with BN. Therefore, the aim of this study is to investigate the efficacy of a guided smartphone-based aftercare intervention as an add-on element to treatment as usual (TAU) compared to TAU alone in inpatients with BN. Our primary hypothesis is that the intervention group shows a significantly higher remission rate than TAU at end of treatment.
Eligible patients with BN who are discharged from inpatient treatment will be 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. Assessment points will be as follows: at hospital discharge (=baseline, T0), 16 weeks (=end of the aftercare intervention, T1) and after 10 months (=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
- 13 Years 至 60 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of BN (DSM-5: 307.51) at admission as assessed by the diagnostically relevant items from the Eating Disorder Examination (Hilbert et al. 2016b),
- •sex: female,
- •age: from 13 years onwards to 60 years,
- •regular completion of inpatient treatment,
- •at least a length of inpatient stay of 6 weeks,
- •remission defined as less than once a week of binge eating and compensatory behavior in the past 28 days thus no longer meeting the full criteria for BN according to DSM-5,
- •owner of a smartphone,
- •informed consent of the patient and, in case of minors, also of the parents.
排除标准
- •major depression (Beck Depression Inventory-II (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),
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 assessor-based eating disorder symptom severity over time. Minimum value: 0, maximum value: 6. Higher scores mean a worse outcome.
次要结局
- Changes in stages of change regarding specific eating disorder behaviors(Measured at baseline, week 16 and 6 month follow-up)
- Changes in Eating Disorder Severity (self-report)(Measured at baseline, week 4, week 16 and 6 month follow-up)
- Ratings of suitability of treatment and expectancy of treatment outcome(Measured at week 4)
- 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 general self-efficacy(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)
- Changes in eating disorder specific self-efficacy(Measured at baseline, week 16 and 6 month follow-up)
- 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)
- Therapeutic Alliance(Measured at week 4 and week 16)
研究者
Schlegl Sandra
Principal Investigator
Ludwig-Maximilians - University of Munich
