Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
SMART-AN
Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
1 other identifier
interventional
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedJanuary 14, 2020
January 1, 2020
2.1 years
January 7, 2020
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Eating Disorder Severity (assessor-based)
The Eating Disorder Examination (EDE) will be used to measure asessor-based eating disorder symptom severity over time.
Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary Outcomes (9)
Changes in Body-Mass-Index (BMI)
Measured at baseline, week 16 and 6 month follow-up
Changes in Eating Disorder Severity (self-report)
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
- +4 more secondary outcomes
Study Arms (2)
Intervention group (IG)
EXPERIMENTALControl group (CG)
ACTIVE COMPARATORInterventions
Patients randomized to IG receive a therapist-guided smartphone-based aftercare intervention for a period of 16 weeks. The patients are invited to download for free the German version of "Recovery Record" at the App Store (iPhone) or the Google Play Store (android) to their smartphone and to link with the aftercare therapist. After discharge, patients are asked to monitor their meals at least three times per day (breakfast, lunch, and dinner), that is, to produce a minimum of three logs per day over the subsequent 16 weeks. Furthermore, patients are instructed to monitor their thoughts and feelings as well as their (disordered) behaviors. The aftercare therapist also sets the patients clinical post-discharge goals and makes coping skill suggestions. Individual therapist feedback is provided in-app twice per week during the first four weeks, once per week in weeks 4-8, every other week in weeks 8-12 and once in week 16.
Patients randomized to CG receive TAU i.e. patients and their physicians or therapists decide on post-discharge treatment which is documented at T1 and T2.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- Schoen Clinic Roseneckcollaborator
- Swiss Anorexia Nervosa Foundationcollaborator
Study Sites (1)
Schoen Clinic Roseneck
Prien am Chiemsee, 83209, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Schlegl, PhD
Ludwig Maximilian University Munich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 14, 2020
Study Start
January 1, 2019
Primary Completion
January 31, 2021
Study Completion
July 31, 2021
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share