Bulimia NervosaSMART-BNNCT05728021
Smartphone-based Aftercare for Inpatients With Bulimia Nervosa
A study testing Recovery Record Aftercare and Treatment as usual (TAU) in people with Bulimia Nervosa, run by Ludwig-Maximilians - University of Munich at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 60 years, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Recovery Record Aftercare and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Sep 2020to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
Schoen Clinic Bad Arolsen
Bad Arolsen
Thomas Gärtner, MD
- Recruiting
Klinik Lüneburger Heide
Bad Bevensen
Andreas Leiteritz, MD
- Recruiting
Schoen Clinic Bad Bramstedt
Bad Bramstedt
Gernot Langs, MD
- Recruiting
Schoen Clinic Roseneck
Prien am Chiemsee, 83209
Ulrich Voderholzer, Prof, +49 8051 68-100102, uvoderholzer@schoen-klinik.de
About this study
Official title: Efficacy of a Therapist-guided Smartphone-based Intervention to Support Recovery From Bulimia Nervosa: a Randomized Controlled Multi-center Trial
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.
Read the 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
- Being tested
- Recovery Record Aftercare, Treatment as usual (TAU)
- Keywords
- Bulimia nervosa, Smartphone, Aftercare, Inpatient
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Record AftercareBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Record Aftercare | Experimental | Intervention group (IG) Receives: Behavioral: Recovery Record Aftercare |
| Treatment as usual (TAU) | Active comparator | Control group (CG) Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured from baseline to week 16
Adherence to self-monitoring tasks
Frequency of self-monitoring entries will be tracked automatically through the program server
Measured: Measured from baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Sep 2020
- Primary completionFeb 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Schoen Clinic Roseneck, Schoen Clinic Bad Bramstedt, Schoen Clinic Bad Arolsen, Klinik Lüneburger Heide, Else Kröner Fresenius Foundation
- Responsible party
- Principal investigator, Schlegl Sandra, Ludwig-Maximilians - University of Munich
- Investigators
- Sandra Schlegl, PhD, Principal investigator, Ludwig Maximilian University MunichUlrich Voderholzer, MD, Principal investigator, Schoen Clinic Roseneck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728021
- Sponsor's protocol ID
- 20-084
- Acronym
- SMART-BN
- Status last verified
- Feb 2023
- First submitted
- 9 Sep 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Therapist-guided Smartphone-based Intervention to Support Recovery From Bulimia Nervosa: a Randomized Controlled Multi-center Trial
- ClinicalTrials.gov ID
- NCT05728021
- Acronym / sponsor ID
- SMART-BN / 20-084
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia nervosa, Smartphone, Aftercare, Inpatient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Schoen Clinic Roseneck, Schoen Clinic Bad Bramstedt, Schoen Clinic Bad Arolsen, Klinik Lüneburger Heide, Else Kröner Fresenius Foundation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Record Aftercare | Experimental | Behavioral: Recovery Record AftercareIntervention group (IG) |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usual (TAU)Control group (CG) |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Record AftercarePatients 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. | Behavioural | Recovery Record Aftercare |
| 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. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Changes in Eating Disorder Severity (assessor-based)
Time frame: 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.
12 secondary outcomes
Changes in Eating Disorder Severity (self-report)
Time frame: Measured at baseline, week 4, week 16 and 6 month follow-up
Changes in Body-Mass-Index (BMI)
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in depressive symptoms
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in stages of change regarding specific eating disorder behaviors
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in general self-efficacy
Time frame: Measured at baseline, week 16 and 6 month follow-up
Changes in eating disorder specific self-efficacy
Time frame: Measured at baseline, week 16 and 6 month follow-up
Therapeutic Alliance
Time frame: Measured at week 4 and week 16
Ratings of suitability of treatment and expectancy of treatment outcome
Time frame: Measured at week 4
Participant satisfaction with the app and the aftercare intervention
Time frame: Measured at week 16
Additional outpatient and inpatient treatment after discharge
Time frame: Measured at week 16 and 6 month follow-up
Adherence to the smartphone-based aftercare intervention
Time frame: Measured from baseline to week 16
Adherence to self-monitoring tasks
Time frame: Measured from baseline to week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Schlegl, PhD principal investigator
Ludwig Maximilian University Munich
Ulrich Voderholzer, MD principal investigator
Schoen Clinic Roseneck
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Record Aftercare and Treatment as usual (TAU) in people with Bulimia Nervosa, run by Ludwig-Maximilians - University of Munich at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Schlegl, PhD (+4989440053369, sandra.schlegl@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Eating Disorder Severity (assessor-based) (time frame: Measured at baseline (discharge), at week 16 (end of treatment) and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.