Specialized Post-Inpatient Psychotherapy for sustained Recovery in Anorexia Nervosa via Videoconference (SUSTAIN) – a randomized controlled Trial
Not Applicable
Recruiting
- Conditions
- F50.0F50.1Anorexia nervosaAtypical anorexia nervosa
- Registration Number
- DRKS00023372
- Lead Sponsor
- niversitätsklinikum Tübingen, Innere Medizin VI, Psychosomatische Medizin und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
(1) patients with diagnosis of AN and subsyndromal AN according to DSM-5 at inpatient/
daypatient admission,
(2) regular completion of inpatient/daypatient treatment,
(3) minimum weight gain of 1 BMI point during inpatient/day-patient treatment,
(4) BMI = 15 kg/m² at beginning of the study (T0),
(5) age = 18 years,
(6) written informed consent
Exclusion Criteria
(1) suicidal ideation,
(2) psychotic (F20-F29) or bipolar I disorder (F30.1 - F30.8) lifetime,
(3) medium to severe current substance abuse (F10.2-F19.2),
(4) serious unstable medical problems (e.g. electrolyte lapse, cardiovascular, hepatic or renal disturbances) that require acute treatment
(5) participation in other treatment studies, treatments, tenant groups during T0-T2
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method difference of BMI between study inclusion (T0) and end of treatment (T2)
- Secondary Outcome Measures
Name Time Method (1) BMI course over five assessment points: <br>T(-1) admission to inpatient/day-patient care, T0 study inclusion and randomisation in the last week of inpatient/daypatient care, T1 interim assessment 4 months +/- 2 weeks after treatment start, T2 end of treatment +/- 2 weeks; T3 6 months follow-up +/- 1 month; <br>(2) proportion of relapse; <br>(3) eating disorder pathology, <br>(4) general psychopathology, <br>(5) cost-effectiveness,<br>(6) time to dropout from the post-inpatient treatment