Clinical trial NCT04228939: Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
Official title: Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Schoen Clinic Roseneck
name: Swiss Anorexia Nervosa Foundation
First posted: 2020-01-14
Enrollment: 184
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Eating Disorder Severity (assessor-based)
timeFrame: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary outcomes:
measure: Changes in Body-Mass-Index (BMI)
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in Eating Disorder Severity (self-report)
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in depressive symptoms
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in stages of change regarding specific eating disorder behaviors
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in self-efficay
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Participant satisfaction with the app and the aftercare intervention
timeFrame: Measured at week 16
measure: Additional outpatient and inpatient treatment after discharge
timeFrame: Measured at week 16 and 6 month follow-up
measure: Adherence to the smartphone-based aftercare intervention
timeFrame: Measured from baseline to week 16
measure: Adherence to self-monitoring tasks
timeFrame: Measured from baseline to week 16
Other outcomes:
Locations:
city: Prien am Chiemsee
country: Germany
facility: Schoen Clinic Roseneck
Study officials:
affiliation: Ludwig Maximilian University Munich
name: Sandra Schlegl, PhD
role: PRINCIPAL_INVESTIGATOR
References: