Background
Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a ‘step-down’ treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation.
Methods
386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden.
Discussion
The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision.
Trial registration
ISRCTN ISRCTN10166784. Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.
The Scottish Health Advisory Service (SHAS) was established in 1970 to provide information to the Secretary of State for Scotland and the Health Board on the management and running of hospitals for the elderly and for patients with mental illness and learning disability. The Health Advisory Service serves a similar purpose in England and Wales. The purpose of SHAS is to promote high standards of health care for these patients. The SHAS achieves this in different ways, but one of their main functions is to visit the hospitals regularly to assess the quality and effectiveness of the service.
We have studied the GABAb receptor-mediated neurotransmissions of alcoholic patients by administering baclofen 10 mg orally and measuring the growth hormone (GH) response. There was a minimal GH response to the baclofen in one of eight control subjects and a greater GH response in 11 of the 16 alcoholic patients. There is thus evidence for increased transmission at the GABAb receptor in detoxified patients with alcohol-dependence syndrome.
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