Clinical trial NCT05728021: Smartphone-based Aftercare for Inpatients With Bulimia Nervosa
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
Overall status: UNKNOWN
Phase: NA
Conditions: Bulimia Nervosa
Keywords: Bulimia nervosa
Smartphone
Aftercare
Inpatient
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Schoen Clinic Roseneck
name: Schoen Clinic Bad Bramstedt
name: Schoen Clinic Bad Arolsen
name: Klinik Lüneburger Heide
name: Else Kröner Fresenius Foundation
First posted: 2023-02-14
Enrollment: 172
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes in Eating Disorder Severity (assessor-based)
timeFrame: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
Secondary outcomes:
measure: Changes in Eating Disorder Severity (self-report)
timeFrame: Measured at baseline, week 4, week 16 and 6 month follow-up
measure: Changes in Body-Mass-Index (BMI)
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in depressive symptoms
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in stages of change regarding specific eating disorder behaviors
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in general self-efficacy
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Changes in eating disorder specific self-efficacy
timeFrame: Measured at baseline, week 16 and 6 month follow-up
measure: Therapeutic Alliance
timeFrame: Measured at week 4 and week 16
measure: Ratings of suitability of treatment and expectancy of treatment outcome
timeFrame: Measured at week 4
measure: Participant satisfaction with the app and the aftercare intervention
timeFrame: Measured at week 16
measure: Additional outpatient and inpatient treatment after discharge
timeFrame: Measured at week 16 and 6 month follow-up
measure: Adherence to the smartphone-based aftercare intervention
timeFrame: Measured from baseline to week 16
measure: Adherence to self-monitoring tasks
timeFrame: Measured from baseline to week 16
Other outcomes:
Locations:
city: Bad Arolsen
country: Germany
facility: Schoen Clinic Bad Arolsen
city: Bad Bevensen
country: Germany
facility: Klinik Lüneburger Heide
city: Bad Bramstedt
country: Germany
facility: Schoen Clinic Bad Bramstedt
city: Prien am Chiemsee
country: Germany
facility: Schoen Clinic Roseneck
Study officials:
affiliation: Ludwig Maximilian University Munich
name: Sandra Schlegl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schoen Clinic Roseneck
name: Ulrich Voderholzer, MD
role: PRINCIPAL_INVESTIGATOR
References: