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Smartphone-based Aftercare for Inpatients With Anorexia Nervosa (SMART-AN)

L

Ludwig Maximilian University of Munich

Status

Unknown

Conditions

Anorexia Nervosa

Treatments

Behavioral: Recovery Record aftercare
Behavioral: Treatment as usual (TAU)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

184 estimated patients

Sex

Female

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

184 participants in 2 patient groups

Intervention group (IG)
Experimental group
Treatment:
Behavioral: Recovery Record aftercare
Control group (CG)
Active Comparator group
Treatment:
Behavioral: Treatment as usual (TAU)

Trial contacts and locations

1

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Central trial contact

Ulrich Voderholzer, Prof; Sandra Schlegl, PhD

Data sourced from clinicaltrials.gov

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