Smartphone-based Aftercare for Inpatients With Anorexia Nervosa

Last updated: January 10, 2020
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Treatment

N/A

Clinical Study ID

NCT04228939
78-17
  • Ages 12-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 inpatienttreatment,

  • owner of a smartphone,

  • informed consent of the patient and, in case of minors, also of the parents.

Exclusion

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.

Study Design

Total Participants: 184
Study Start date:
January 01, 2019
Estimated Completion Date:
July 31, 2021

Study 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).

Connect with a study center

  • Schoen Clinic Roseneck

    Prien am Chiemsee, 83209
    Germany

    Active - Recruiting

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