Smartphone-based Aftercare for Inpatients With Bulimia Nervosa

NCT ID: NCT05728021

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-08-31

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).

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Recovery Record Aftercare

Intervention group (IG)

Group Type: EXPERIMENTAL

Recovery Record Aftercare

Intervention Type: 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.

Treatment as usual (TAU)

Control group (CG)

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: 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.

Interventions

Recovery Record Aftercare

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

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. Patients from the CG are also assessed at all assessment points.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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),

2. sex: female,

3. age: from 13 years onwards to 60 years,

4. regular completion of inpatient treatment,

5. at least a length of inpatient stay of 6 weeks,

6. 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,

7. owner of a smartphone,

8. informed consent of the patient and, in case of minors, also of the parents.

Exclusion Criteria

1. major depression (Beck Depression Inventory-II (BDI-II) > 29 at discharge),

2. suicidal tendency (item 9 of BDI-II > 1 at discharge),

3. very high level of care after inpatient treatment (e.g. therapeutic living community, day clinic),

4. pregnancy.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Schoen Clinic Roseneck

UNKNOWN

Sponsor Role: collaborator

Schoen Clinic Bad Bramstedt

UNKNOWN

Sponsor Role: collaborator

Schoen Clinic Bad Arolsen

UNKNOWN

Sponsor Role: collaborator

Klinik Lüneburger Heide

UNKNOWN

Sponsor Role: collaborator

Else Kröner Fresenius Foundation

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Schlegl Sandra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Schlegl, PhD

Role: PRINCIPAL_INVESTIGATOR

Ludwig Maximilian University Munich

Ulrich Voderholzer, MD

Role: PRINCIPAL_INVESTIGATOR

Schoen Clinic Roseneck

Locations

Schoen Clinic Bad Arolsen

Bad Arolsen, , Germany

Site Status: RECRUITING

Klinik Lüneburger Heide

Bad Bevensen, , Germany

Site Status: RECRUITING

Schoen Clinic Bad Bramstedt

Bad Bramstedt, , Germany

Site Status: RECRUITING

Schoen Clinic Roseneck

Prien am Chiemsee, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sandra Schlegl, PhD

Role: CONTACT

sandra.schlegl@med.uni-muenchen.de

+4989440053369

Ulrich Voderholzer, MD

Role: CONTACT

uvoderholzer@schoen-klinik.de

+49805168100102

Facility Contacts

Thomas Gärtner, MD

Role: primary

Andreas Leiteritz, MD

Role: primary

Gernot Langs, MD

Role: primary

Ulrich Voderholzer, Prof

Role: primary

uvoderholzer@schoen-klinik.de

+49 8051 68-100102

Related Links

https://www.ekfs.de/en/scientific-funding/currently-funded-projects/efficacy-therapist-guided-smartphone-based

Related Info

Other Identifiers

20-084

Identifier Type: -

Identifier Source: org_study_id