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Smartphone-based Aftercare for Inpatients With Bulimia Nervosa (SMART-BN)

Primary Purpose

Bulimia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Recovery Record Aftercare
Treatment as usual (TAU)
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia nervosa, Smartphone, Aftercare, Inpatient

Eligibility Criteria

13 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: primary diagnosis of BN (DSM-5: 307.51) at admission as assessed by the diagnostically relevant items from the Eating Disorder Examination (Hilbert et al. 2016b), sex: female, age: from 13 years onwards to 60 years, regular completion of inpatient treatment, at least a length of inpatient stay of 6 weeks, remission defined as less than once a week of binge eating and compensatory behavior in the past 28 days thus no longer meeting the full criteria for BN according to DSM-5, owner of a smartphone, informed consent of the patient and, in case of minors, also of the parents. Exclusion Criteria: major depression (Beck Depression Inventory-II (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 Bad ArolsenRecruiting
  • Klinik Lüneburger HeideRecruiting
  • Schoen Clinic Bad BramstedtRecruiting
  • Schoen Clinic RoseneckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recovery Record Aftercare

Treatment as usual (TAU)

Arm Description

Intervention group (IG)

Control group (CG)

Outcomes

Primary Outcome Measures

Changes in Eating Disorder Severity (assessor-based)
The Eating Disorder Examination (EDE) will be used to measure assessor-based eating disorder symptom severity over time. Minimum value: 0, maximum value: 6. Higher scores mean a worse outcome.

Secondary Outcome Measures

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. Minimum value: 0, maximum value: 6. Higher scores mean a worse outcome.
Changes in Body-Mass-Index (BMI)
Weight and height will be used to measure BMI over time.
Changes in depressive symptoms
The Beck Depression Inventory-II (BDI-II) will be used to measure depressive symptoms. Minimal value: 0, maximum value: 63. Higher scores mean a worse outcome.
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 (precontemplation, contemplation, preparation, action, maintenance, termination) specific eating disorder behaviors over time.
Changes in general self-efficacy
The General Self-Efficacy Scale (GSE) will be used to measure self-efficacy over time. Minimum value: 10, maximum value: 40. Higher scores mean a better outcome.
Changes in eating disorder specific self-efficacy
A self-efficacy scale will be used to measure self-efficacy regarding patients' confidence about resisting binge eating over time. Minimum value: 0, maximum value: 3. Higher scores mean better outcomes.
Therapeutic Alliance
The Helping Alliance Questionnaire (HAQ) will be used to measure therapeutic alliance. Minimum value: 11, maximum value: 66. Higher scores mean a better outcome.
Ratings of suitability of treatment and expectancy of treatment outcome
Ten-point visual analogue scales will assess patients' perceptions of the suitability of the aftercare intervention and their expectations that they would maintain their remission status. Higher scores mean a better suitability and expectancy.
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. Minimum value: 1, maximum value: 5. Higher scores mean a better satisfaction.
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

First Posted
September 9, 2020
Last Updated
February 13, 2023
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Schoen Clinic Roseneck, Schoen Clinic Bad Bramstedt, Schoen Clinic Bad Arolsen, Klinik Lüneburger Heide, Else Kröner Fresenius Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05728021
Brief Title
Smartphone-based Aftercare for Inpatients With Bulimia Nervosa
Acronym
SMART-BN
Official Title
Efficacy of a Therapist-guided Smartphone-based Intervention to Support Recovery From Bulimia Nervosa: a Randomized Controlled Multi-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Schoen Clinic Roseneck, Schoen Clinic Bad Bramstedt, Schoen Clinic Bad Arolsen, Klinik Lüneburger Heide, Else Kröner Fresenius 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 bulimia nervosa (BN) is recommended in extreme or severe cases and/or 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 BN to support recovery.
Detailed Description
Bulimia nervosa (BN) is a severe mental disorder characterized by recurrent episodes of binge eating and recurrent inappropriate compensatory behaviors to prevent weight gain. Evidence-based psychological treatments exist, however, even if treatment is successful in reducing behaviors such as binge eating and purging, abstinence rates may remain low and even if remission or abstinence have been received after treatment relapse rates are substantial. There is evidence that the stability of remission increases if the corresponding symptom improvement lasts at least for 4 months. Studies on the effectiveness of inpatient treatment in adult patients with BN show responder rates of up to 77%. However, it is often difficult for patients to maintain therapy success after discharge, as relapse rates reach up to 40% with the highest risk during the first 5 or 6 months after remission. There is preliminary evidence for efficacy regarding the potential of technology-based interventions in aftercare for patients with BN. However, so far, there is no study evaluating a smartphone-based aftercare intervention for patients with BN. Therefore, the aim of this study is to investigate the efficacy of a guided smartphone-based aftercare intervention as an add-on element to treatment as usual (TAU) compared to TAU alone in inpatients with BN. Our primary hypothesis is that the intervention group shows a significantly higher remission rate than TAU at end of treatment. Eligible patients with BN who are discharged from inpatient treatment will be 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. Assessment points will be as follows: at hospital discharge (=baseline, T0), 16 weeks (=end of the aftercare intervention, T1) and after 10 months (=6-month follow-up, T2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
Bulimia nervosa, Smartphone, Aftercare, Inpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery Record Aftercare
Arm Type
Experimental
Arm Description
Intervention group (IG)
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
Control group (CG)
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 (eating 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 5-8 and every other week in weeks 9-16.
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. Patients from the CG are also assessed at all assessment points.
Primary Outcome Measure Information:
Title
Changes in Eating Disorder Severity (assessor-based)
Description
The Eating Disorder Examination (EDE) will be used to measure assessor-based eating disorder symptom severity over time. Minimum value: 0, maximum value: 6. Higher scores mean a worse outcome.
Time Frame
Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary Outcome Measure Information:
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. Minimum value: 0, maximum value: 6. Higher scores mean a worse outcome.
Time Frame
Measured at baseline, week 4, week 16 and 6 month follow-up
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 depressive symptoms
Description
The Beck Depression Inventory-II (BDI-II) will be used to measure depressive symptoms. Minimal value: 0, maximum value: 63. Higher scores mean a worse outcome.
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 (precontemplation, contemplation, preparation, action, maintenance, termination) specific eating disorder behaviors over time.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in general self-efficacy
Description
The General Self-Efficacy Scale (GSE) will be used to measure self-efficacy over time. Minimum value: 10, maximum value: 40. Higher scores mean a better outcome.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Changes in eating disorder specific self-efficacy
Description
A self-efficacy scale will be used to measure self-efficacy regarding patients' confidence about resisting binge eating over time. Minimum value: 0, maximum value: 3. Higher scores mean better outcomes.
Time Frame
Measured at baseline, week 16 and 6 month follow-up
Title
Therapeutic Alliance
Description
The Helping Alliance Questionnaire (HAQ) will be used to measure therapeutic alliance. Minimum value: 11, maximum value: 66. Higher scores mean a better outcome.
Time Frame
Measured at week 4 and week 16
Title
Ratings of suitability of treatment and expectancy of treatment outcome
Description
Ten-point visual analogue scales will assess patients' perceptions of the suitability of the aftercare intervention and their expectations that they would maintain their remission status. Higher scores mean a better suitability and expectancy.
Time Frame
Measured at week 4
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. Minimum value: 1, maximum value: 5. Higher scores mean a better satisfaction.
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
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary diagnosis of BN (DSM-5: 307.51) at admission as assessed by the diagnostically relevant items from the Eating Disorder Examination (Hilbert et al. 2016b), sex: female, age: from 13 years onwards to 60 years, regular completion of inpatient treatment, at least a length of inpatient stay of 6 weeks, remission defined as less than once a week of binge eating and compensatory behavior in the past 28 days thus no longer meeting the full criteria for BN according to DSM-5, owner of a smartphone, informed consent of the patient and, in case of minors, also of the parents. Exclusion Criteria: major depression (Beck Depression Inventory-II (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, MD
Phone
+49805168100102
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
First Name & Middle Initial & Last Name & Degree
Ulrich Voderholzer, MD
Organizational Affiliation
Schoen Clinic Roseneck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Clinic Bad Arolsen
City
Bad Arolsen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Gärtner, MD
Facility Name
Klinik Lüneburger Heide
City
Bad Bevensen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Leiteritz, MD
Facility Name
Schoen Clinic Bad Bramstedt
City
Bad Bramstedt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gernot Langs, MD
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
Links:
URL
https://www.ekfs.de/en/scientific-funding/currently-funded-projects/efficacy-therapist-guided-smartphone-based
Description
Related Info

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Smartphone-based Aftercare for Inpatients With Bulimia Nervosa

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