Smartphone-based Aftercare for Inpatients With Anorexia Nervosa

NCT ID: NCT04228939

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-07-31

Brief Summary

Inpatient treatment for patients with anorexia nervosa (AN) is recommended in extreme or severe cases 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 AN to support symptom stabilization or continued improvement.

Detailed Description

Anorexia nervosa (AN) is a severe, often chronic and life-threatening disorder. Relapse after treatment is common with relapse rates ranging between 9 and 52% and being highest within the first year following treatment particularly as early as 3 months posttreatment. Even if weight restoration is achieved, it is quite difficult for patients to sustain improvements after treatment, so aftercare and relapse prevention are essential research topics. There is a recent review on internet- and mobile-based aftercare and relapse prevention in mental disorders that concludes that there is some evidence that such interventions are feasible instruments for maintaining treatment gains for some mental disorders, including eating disorders (EDs). However, the authors claim for further high quality, large-scale trials that are needed to expand research fields. So, the aim of this study is to prove the efficacy of a guided smartphone-based aftercare intervention for inpatients with AN. Our primary hypothesis is that at the end of aftercare intervention (T1), the intervention group shows a significantly lower eating disorder symptomatology than the control group.

Eligible patients with AN who are discharged from inpatient treatment are 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. Assessments include structured interviews as well as online questionnaires and are taken at baseline (discharge, T0), end of the aftercare intervention (T1) as well as 6-month follow-up (T2).

Conditions

Anorexia Nervosa

Study Design

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

Study Groups

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 (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 4-8, every other week in weeks 8-12 and once in week 16.

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.

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 (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 4-8, every other week in weeks 8-12 and once in week 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• primary diagnosis of AN (DSM-5: 307.1),
• sex: female,
• age: from 12 years onwards to 60 years,
• regular completion of inpatient treatment,
• at least a length of inpatient stay of 6 weeks,
• BMI at discharge at least 15, at least a 1-point BMI increase during inpatient treatment,
• owner of a smartphone,
• informed consent of the patient and, in case of minors, also of the parents.

Exclusion Criteria

• major depression (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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Schoen Clinic Roseneck

UNKNOWN

Sponsor Role: collaborator

Swiss Anorexia Nervosa Foundation

UNKNOWN

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

Locations

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, Prof

Role: CONTACT

uvoderholzer@schoen-klinik.de

+49 8051 68-100102

Facility Contacts

Ulrich Voderholzer, Prof

Role: primary

uvoderholzer@schoen-klinik.de

+49 8051 68-100102

Other Identifiers

78-17

Identifier Type: -

Identifier Source: org_study_id