An interventional study of Recovery Record Aftercare and Treatment as usual (TAU) in Bulimia Nervosa, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 4 sites in Germany. Open to female participants aged 13 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment
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.
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).
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's planned enrollment of 172 is above the median of 61 across 249 interventional studies indexed under Bulimia.
Browse Bulimia studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention group (IG)
Behavioral: Recovery Record Aftercare
Control group (CG)
Behavioral: Treatment as usual (TAU)
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.
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.
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.
Time frame: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up
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.
Time frame: Measured at baseline, week 4, week 16 and 6 month follow-up
Changes in Body-Mass-Index (BMI)
Weight and height will be used to measure BMI over time.
Time frame: Measured at baseline, week 16 and 6 month follow-up
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.
Time frame: Measured at baseline, week 16 and 6 month follow-up
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.
Time frame: Measured at baseline, week 16 and 6 month follow-up
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.
Time frame: Measured at baseline, week 16 and 6 month follow-up
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.
Time frame: Measured at baseline, week 16 and 6 month follow-up
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.
Time frame: Measured at week 4 and week 16
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.
Time frame: Measured at week 4
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.
Time frame: Measured at week 16
Additional outpatient and inpatient treatment after discharge
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
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.
Time frame: Measured from baseline to week 16
Adherence to self-monitoring tasks
Frequency of self-monitoring entries will be tracked automatically through the program server
Time frame: Measured from baseline to week 16
Plan to share: No
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Ludwig-Maximilians - University of Munich