Smartphone-based Aftercare for Inpatients With Bulimia Nervosa

NCT05728021 | Unknown

• 1 other identifier: 20-084
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 4

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.

Conditions

Bulimia Nervosa

Keywords

Bulimia nervosa; Smartphone; Aftercare; Inpatient

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up

Secondary Outcomes (12)

• Changes in Eating Disorder Severity (self-report)

  Measured at baseline, week 4, week 16 and 6 month follow-up

• Changes in Body-Mass-Index (BMI)

  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 general self-efficacy

  Measured at baseline, week 16 and 6 month follow-up

Study Arms (2)

Recovery Record Aftercare

EXPERIMENTAL

Intervention group (IG)

Behavioral: Recovery Record Aftercare

Treatment as usual (TAU)

ACTIVE COMPARATOR

Control group (CG)

Behavioral: Treatment as usual (TAU)

Interventions

Recovery Record Aftercare BEHAVIORAL

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.

Recovery Record Aftercare

Treatment as usual (TAU) BEHAVIORAL

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.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Schoen Clinic Roseneck: collaborator
• Schoen Clinic Bad Bramstedt: collaborator
• Schoen Clinic Bad Arolsen: collaborator
• Klinik Lüneburger Heide: collaborator
• Else Kröner Fresenius Foundation: collaborator

Study Sites (4)

Schoen Clinic Bad Arolsen

Bad Arolsen, Germany

RECRUITING

Klinik Lüneburger Heide

Bad Bevensen, Germany

RECRUITING

Schoen Clinic Bad Bramstedt

Bad Bramstedt, Germany

RECRUITING

Schoen Clinic Roseneck

Prien am Chiemsee, 83209, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Sandra Schlegl, PhD

  Ludwig Maximilian University Munich

  PRINCIPAL INVESTIGATOR

• Ulrich Voderholzer, MD

  Schoen Clinic Roseneck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Schlegl, PhD

CONTACT

+4989440053369; sandra.schlegl@med.uni-muenchen.de

Ulrich Voderholzer, MD

CONTACT

+49805168100102; uvoderholzer@schoen-klinik.de

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: September 9, 2020
• First Posted: February 14, 2023
• Study Start: September 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)