Smartphone-based Aftercare for Inpatients With Bulimia Nervosa

Not Applicable

Recruiting

• Conditions: Bulimia Nervosa
• Interventions: Behavioral: Recovery Record Aftercare; Behavioral: Treatment as usual (TAU)

• Registration Number: NCT05728021
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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).

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-09
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-02
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovery Record Aftercare	Recovery Record Aftercare	Intervention group (IG)
Treatment as usual (TAU)	Treatment as usual (TAU)	Control group (CG)

Primary Outcome Measures

Name	Time	Method
Changes in Eating Disorder Severity (assessor-based)	Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up	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

Name	Time	Method
Changes in stages of change regarding specific eating disorder behaviors	Measured at baseline, week 16 and 6 month follow-up	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 Eating Disorder Severity (self-report)	Measured at baseline, week 4, week 16 and 6 month follow-up	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.
Ratings of suitability of treatment and expectancy of treatment outcome	Measured at week 4	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.
Changes in Body-Mass-Index (BMI)	Measured at baseline, week 16 and 6 month follow-up	Weight and height will be used to measure BMI over time.
Changes in depressive symptoms	Measured at baseline, week 16 and 6 month follow-up	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 general self-efficacy	Measured at baseline, week 16 and 6 month follow-up	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.
Participant satisfaction with the app and the aftercare intervention	Measured at week 16	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.
Adherence to self-monitoring tasks	Measured from baseline to week 16	Frequency of self-monitoring entries will be tracked automatically through the program server
Changes in eating disorder specific self-efficacy	Measured at baseline, week 16 and 6 month follow-up	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.
Additional outpatient and inpatient treatment after discharge	Measured at week 16 and 6 month follow-up	Number and length of outpatient or inpatient treatment (rehospitalization) since discharge will be assessed.
Adherence to the smartphone-based aftercare intervention	Measured from baseline to week 16	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.
Therapeutic Alliance	Measured at week 4 and week 16	The Helping Alliance Questionnaire (HAQ) will be used to measure therapeutic alliance. Minimum value: 11, maximum value: 66. Higher scores mean a better outcome.

Trial Locations

Locations (4)

Klinik Lüneburger Heide; 🇩🇪 Bad Bevensen, Germany

Schoen Clinic Bad Arolsen; 🇩🇪 Bad Arolsen, Germany

Schoen Clinic Roseneck; 🇩🇪 Prien am Chiemsee, Germany

Schoen Clinic Bad Bramstedt; 🇩🇪 Bad Bramstedt, Germany