Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
Sponsors
Lead Sponsor
Collaborators
Source
Ludwig-Maximilians - University of Munich
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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).
Overall Status
Unknown status
Start Date
2019-01-01
Completion Date
2021-07-31
Primary Completion Date
2021-01-31
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Changes in Eating Disorder Severity (assessor-based) |
Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up |
Secondary Outcome
Measure |
Time Frame |
|
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 |
|
Participant satisfaction with the app and the aftercare intervention |
Measured at week 16 |
|
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 |
|
Adherence to self-monitoring tasks |
Measured from baseline to week 16 |
Enrollment
184
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
Intervention group (IG)
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
Control group (CG)
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.
Gender
Female
Minimum Age
12 Years
Maximum Age
60 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Sandra Schlegl, PhD |
Principal Investigator |
Ludwig Maximilian University Munich |
Overall Contact
Last Name
Sandra Schlegl, PhD
Phone
+4989440053369
sandra.schlegl@med.uni-muenchen.de
Location
Facility |
Status |
Contact |
|
Schoen Clinic Roseneck Prien am Chiemsee 2852101 83209 Germany |
Recruiting |
Last Name: Ulrich Voderholzer, Prof Phone: +49 8051 68-100102 Email: uvoderholzer@schoen-klinik.de |
Location Countries
Country
Germany
Verification Date
2020-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Ludwig-Maximilians - University of Munich
Investigator Full Name
Schlegl Sandra
Investigator Title
Principal Investigator
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Therapeutics
Arm Group
Arm Group Label
Intervention group (IG)
Arm Group Type
Experimental
Arm Group Label
Control group (CG)
Arm Group Type
Active Comparator
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Ulrich Voderholzer, Prof
Phone
+49 8051 68-100102
uvoderholzer@schoen-klinik.de
Acronym
SMART-AN
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
January 7, 2020
Study First Submitted Qc
January 10, 2020
Study First Posted
January 14, 2020
Last Update Submitted
January 10, 2020
Last Update Submitted Qc
January 10, 2020
Last Update Posted
January 14, 2020
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.