Smartphone-based Aftercare for Inpatients With Anorexia Nervosa (SMART-AN)
Primary Purpose
Anorexia Nervosa
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Recovery Record aftercare
Treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
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.
Sites / Locations
- Schoen Clinic RoseneckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group (IG)
Control group (CG)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in Body-Mass-Index (BMI)
Weight and height will be used to measure BMI over time.
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.
Changes in depressive symptoms
The Beck Depression Inventory-II (BDI-II) will be used to measure depressive symptoms over time.
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.
Changes in self-efficay
The General Self-Efficacy Scale (GSE) will be used to measure self-efficacy over time.
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.
Additional outpatient and inpatient treatment after discharge
Number and length of outpatient or inpatient treatment (rehospitalization) since discharge will be assessed.
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.
Adherence to self-monitoring tasks
Frequency of self-monitoring entries will be tracked automatically through the program server
Full Information
NCT ID
NCT04228939
First Posted
January 7, 2020
Last Updated
January 10, 2020
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Schoen Clinic Roseneck, Swiss Anorexia Nervosa Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04228939
Brief Title
Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
Acronym
SMART-AN
Official Title
Therapist-guided Smartphone-based Aftercare for Inpatients With Severe Anorexia Nervosa (SMART-AN): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Schoen Clinic Roseneck, Swiss Anorexia Nervosa Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Title
Control group (CG)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Recovery Record aftercare
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in Eating Disorder Severity (assessor-based)
Description
The Eating Disorder Examination (EDE) will be used to measure asessor-based eating disorder symptom severity over time.
Time Frame
Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary Outcome Measure Information:
Title
Changes in Body-Mass-Index (BMI)
Description
Weight and height will be used to measure BMI over time.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in Eating Disorder Severity (self-report)
Description
The Eating Disorder Examination Questionnaire (EDE-Q) will be used to measure self-reported eating disorder symptom severity over time.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in depressive symptoms
Description
The Beck Depression Inventory-II (BDI-II) will be used to measure depressive symptoms over time.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in stages of change regarding specific eating disorder behaviors
Description
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.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in self-efficay
Description
The General Self-Efficacy Scale (GSE) will be used to measure self-efficacy over time.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Participant satisfaction with the app and the aftercare intervention
Description
A self-developed questionnaire will be used to assess self-reported satisfaction with the app and the aftercare intervention.
Time Frame
Measured at week 16
Title
Additional outpatient and inpatient treatment after discharge
Description
Number and length of outpatient or inpatient treatment (rehospitalization) since discharge will be assessed.
Time Frame
Measured at week 16 and 6 month follow-up
Title
Adherence to the smartphone-based aftercare intervention
Description
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.
Time Frame
Measured from baseline to week 16
Title
Adherence to self-monitoring tasks
Description
Frequency of self-monitoring entries will be tracked automatically through the program server
Time Frame
Measured from baseline to week 16
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Schlegl, PhD
Phone
+4989440053369
Email
sandra.schlegl@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Voderholzer, Prof
Phone
+49 8051 68-100102
Email
uvoderholzer@schoen-klinik.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Schlegl, PhD
Organizational Affiliation
Ludwig Maximilian University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Clinic Roseneck
City
Prien am Chiemsee
ZIP/Postal Code
83209
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Voderholzer, Prof
Phone
+49 8051 68-100102
Email
uvoderholzer@schoen-klinik.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smartphone-based Aftercare for Inpatients With Anorexia Nervosa
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