Specialized post-inpatient psychotherapy for sustained recovery in anorexia nervosa via videoconference – study protocol of the randomized controlled SUSTAIN trial

Journal of Eating Disorders

卷:9

Wolfgang Bethge¹  Tobias Hofmann²  Martin Teufel³  Beate Wild⁴  Stephan Herpertz⁵  Jörn von Wietersheim⁶  Almut Zeeck⁷  Stephan Zipfel⁸  Kathrin Schag⁸  Katrin Elisabeth Giel⁸  Florian Junne⁸  Peter Martus⁹  Antonius Schneider¹⁰  Ulrich Voderholzer¹¹  Ulrike Schmidt¹² 

[1] Center for Clinical Trials (ZKS Tübingen), Medical Faculty Tübingen;

[2] Center for Internal Medicine and Dermatology, Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health;

[3] Clinic for Psychosomatic Medicine and Psychotherapy, University of Duisburg-Essen, LVR University-Hospital Essen;

[4] Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg;

[5] Department of Psychosomatic Medicine and Psychotherapy, LWL-University Hospital Bochum, Ruhr University Bochum;

[6] Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center;

[7] Department of Psychosomatic Medicine und Psychotherapy, Center for Mental Health, Faculty of Medicine, University of Freiburg;

[8] Department of Psychosomatic Medicine und Psychotherapy, Medical University Hospital Tübingen, Eberhard Karls University Tübingen;

[9] Institute for Clinical Epidemiology and Applied Biostatistics, Medical Faculty, Eberhard Karls University Tübingen;

[10] Institute of General Practice and Health Services Research, TUM School of Medicine, Technical University of Munich;

[11] Schoen Clinic Roseneck;

[12] Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College London;

关键词: Aftercare;    Anorexia nervosa;    Eating disorder;    Inpatient;    Psychotherapy;    RCT;   

DOI  :  10.1186/s40337-021-00416-6

来源: DOAJ

【 摘 要 】

Abstract Background A major barrier to long-term recovery from anorexia nervosa (AN) are early and frequent relapses after inpatient treatment. There is an urgent need for enhanced continuity of specialized care involving effective aftercare interventions and relapse prevention strategies in order to improve the long-term outcome for patients with AN. Methods SUSTAIN is a multi-center, prospective, randomized-controlled trial investigating the efficacy of a novel post-inpatient aftercare intervention for patients with AN as compared to optimized treatment-as-usual (TAU-O). The SUSTAIN aftercare intervention is based on the cognitive-interpersonal maintenance model of AN and specifically tailored to achieve sustained recovery in AN following inpatient treatment. The SUSTAIN aftercare intervention comprises 20 treatment sessions over eight months and will be predominantly delivered via videoconference to overcome discontinuity of care. TAU-O refers to routine outpatient psychotherapy as generally offered in the German health care system. A total number of 190 patients receiving inpatient or day-hospital treatment for AN will be randomized and assessed over a 14-month period following randomization including a 6 months follow-up. Minimum Body Mass Index (BMI) is 15 kg/m2 at trial inclusion. The primary efficacy endpoint is the change in BMI between baseline (T0) and end of treatment (T2) adjusted for baseline BMI. Key secondary outcomes comprise eating disorder and general psychopathology, quality of life, proportion of relapse and of weight restoration, and cost-effectiveness. Discussion The results of the present trial will provide evidence if the novel aftercare intervention fosters sustained recovery in patients affected by severe courses of AN. Trial registration The SUSTAIN trial was prospectively registered on November 18, 2020, under the registration number DRKS00023372 at the German Clinical Trials Register ( https://www.drks.de/drks_web/ ) which is an acknowledged primary register of the World Health Organization ( http://apps.who.int/trialsearch/ ). Protocol version: 1.2.

【 授权许可】

Unknown