ABSTRACT
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.
Subject(s)
Anorexia Nervosa , Feeding and Eating Disorders , Adult , Anorexia Nervosa/diagnosis , Anorexia Nervosa/therapy , Cost-Benefit Analysis , Humans , Inpatients , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
BACKGROUND: In the past 10 years the new atypical antipsychotic drugs have stimulated further interest in the pharmacological management of schizophrenia. The risk of movement disorders has been reported to be less with these new agents. AIMS: To examine the current prevalence of movement disorders among all people with schizophrenia in a discrete geographical area, to compare the prevalence in patients receiving and not receiving atypical antipsychotic drugs; and to compare current prevalence with prevalence over the past 20 years. METHOD: In Nithsdale, south-west Scotland, in 1999/2000, we replicated previous studies by using the Abnormal Involuntary Movements Scale, Simpson-Angus scale and Barnes Akathisia Rating Scale to measure tardive dyskinesia, parkinsonism and akathisia, respectively. Mental state was assessed by the Positive and Negative Syndrome Scale. RESULTS: In 136 patients the prevalence of probable tardive dyskinesia was 43%, of parkinsonism 35% and of akathisia 15%. Parkinsonism was present as often in those receiving atypicals as in those receiving standard oral antipsychotics. The prevalence of tardive dyskinesia has doubled over 20 years. CONCLUSIONS: Movement disorders remain significant problems for patients despite the introduction of atypical antipsychotic drugs.