Anorexia NervosaSMART-ANNCT04228939
Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
A study testing Recovery Record aftercare and Treatment as usual (TAU) in people with Anorexia Nervosa, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Recovery Record aftercare and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Clinic Roseneck
Prien am Chiemsee, 83209
Ulrich Voderholzer, Prof, +49 8051 68-100102, uvoderholzer@schoen-klinik.de
About this study
Official title: Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Anorexia Nervosa
- Being tested
- Recovery Record aftercare, Treatment as usual (TAU)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Record aftercareBehavioural
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.
Treatment as usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Experimental | Not described Receives: Behavioral: Recovery Record aftercare |
| Control group (CG) | Active comparator | Not described Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary outcomes (9)
Changes in Body-Mass-Index (BMI)
Weight and height will be used to measure BMI over time.
Measured: Measured at baseline, week 16 and 6 month follow-up
Changes in Eating Disorder Severity (self-report)
The Eating Disorder Examination Questionnaire (EDE-Q) will be used to measure self-reported eating disorder symptom severity over time.
Measured: Measured at baseline, week 16 and 6 month follow-up
Changes in depressive symptoms
The Beck Depression Inventory-II (BDI-II) will be used to measure depressive symptoms over time.
Measured: Measured at baseline, week 16 and 6 month follow-up
Changes in stages of change regarding specific eating disorder behaviors
The Stages of Change Questionnaire for Eating Disorders (SOCQ-ED) will be used to measure changes in stages of change regarding specific eating disorder behaviors over time.
Measured: Measured at baseline, week 16 and 6 month follow-up
Changes in self-efficay
The General Self-Efficacy Scale (GSE) will be used to measure self-efficacy over time.
Measured: Measured at baseline, week 16 and 6 month follow-up
Participant satisfaction with the app and the aftercare intervention
A self-developed questionnaire will be used to assess self-reported satisfaction with the app and the aftercare intervention.
Measured: Measured at week 16
Additional outpatient and inpatient treatment after discharge
Number and length of outpatient or inpatient treatment (rehospitalization) since discharge will be assessed.
Measured: Measured at week 16 and 6 month follow-up
Adherence to the smartphone-based aftercare intervention
Adherence will be measured via dichotomous outcome of drop-out (individuals will be considered as drop-out if they fail to login to the app at all for a period of 14 consecutive days. Adherence will be assessed through application usage data.
Measured: Measured from baseline to week 16
Adherence to self-monitoring tasks
Frequency of self-monitoring entries will be tracked automatically through the program server
Measured: Measured from baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Schoen Clinic Roseneck, Swiss Anorexia Nervosa Foundation
- Responsible party
- Principal investigator, Schlegl Sandra, Ludwig-Maximilians - University of Munich
- Investigators
- Sandra Schlegl, PhD, Principal investigator, Ludwig Maximilian University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228939
- Sponsor's protocol ID
- 78-17
- Acronym
- SMART-AN
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schlegl S, Gerich A, Terhorst Y, Fricke Neumayr C, Voderholzer U. Therapist-Guided Smartphone-Based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): A Randomized Clinical Trial. Int J Eat Disord. 2026 Jun 23. doi: 10.1002/eat.70142. Online ahead of print.
PubMed 42334272
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04228939
- Acronym / sponsor ID
- SMART-AN / 78-17
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Schoen Clinic Roseneck, Swiss Anorexia Nervosa Foundation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Behavioral: Recovery Record aftercare |
| Control group (CG) | Active comparator | Behavioral: Treatment as usual (TAU) |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Record aftercarePatients 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. | Behavioural | Intervention group (IG) |
| Treatment as usual (TAU)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. | Behavioural | Control group (CG) |
Primary outcome
Changes in Eating Disorder Severity (assessor-based)
Time frame: 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.
9 secondary outcomes
Changes in Body-Mass-Index (BMI)
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in Eating Disorder Severity (self-report)
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in depressive symptoms
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in stages of change regarding specific eating disorder behaviors
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in self-efficay
Time frame: Measured at baseline, week 16 and 6 month follow-up
Participant satisfaction with the app and the aftercare intervention
Time frame: Measured at week 16
Additional outpatient and inpatient treatment after discharge
Time frame: Measured at week 16 and 6 month follow-up
Adherence to the smartphone-based aftercare intervention
Time frame: Measured from baseline to week 16
Adherence to self-monitoring tasks
Time frame: Measured from baseline to week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 42334272Schlegl S, Gerich A, Terhorst Y, Fricke Neumayr C, Voderholzer U. Therapist-Guided Smartphone-Based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): A Randomized Clinical Trial. Int J Eat Disord. 2026 Jun 23. doi: 10.1002/eat.70142. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Schlegl, PhD principal investigator
Ludwig Maximilian University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Record aftercare and Treatment as usual (TAU) in people with Anorexia Nervosa, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Schlegl, PhD (+4989440053369, sandra.schlegl@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Eating Disorder Severity (assessor-based) (time frame: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.