The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial.

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.

Adapting and Optimizing Problem Adaptation Therapy (PATH) for People With Mild-Moderate Dementia and Depression.

OBJECTIVE: To adapt and optimize problem adaptation therapy for depression in dementia by grounding it in the lives of people with dementia, caregivers and clinicians. METHODS: A person-centered qualitative approach was taken to elicit the unique cognitive, psychological and social needs of people with dementia relevant to the adaptation of the intervention. A two-stage design was used: the first involved interviews and focus groups to identify priorities and concerns surrounding depression in dementia, the second trialling of the adapted intervention. PARTICIPANTS: Ten people with dementia and nine caregivers participated in individual interviews, 35 healthcare practitioners and clinical academics with experience of working with dementia participated in focus groups. RESULTS: The findings highlight the importance of addressing key themes that typified the experience of depression among people with dementia including: a profound sense of isolation and role loss, the feeling of being both a burden and poorly understood, polarized thinking, interpersonal tensions, diverging views among carers and people with dementia about their capabilities, and changeability in cognitive ability and mood. These themes were used to inform adaptation of the intervention manual, ensuring that its content and delivery addressed the concerns of both people with depression and dementia and those who support them. CONCLUSION: Implications for PATH included a focus on facilitating open communication, supporting the continuation of valued roles, and improving confidence.

Depression in carers of people with dementia from a minority ethnic background: Systematic review and meta-analysis of randomised controlled trials of psychosocial interventions.

OBJECTIVES: Systematic review and meta-analysis to determine the effectiveness of interventions in reducing depressive symptoms in ethnic minority carers of people with dementia. METHODS: We systematically searched EMBASE, CINAHL, MEDLINE, PsycINFO, PsycARTICLES, Applied Social Sciences Index and Abstracts (ASSIA), The Cochrane Central Register of Controlled Trials (CENTRAL), and Sociological Abstracts and Social Policy and Practices databases from 1990 to 2015, supplemented by a grey literature search, hand searches of bibliographies, and contacting authors. Study quality was assessed independently by two researchers using The Effective Public Health Practice Project Quality Assessment Tool, with an inter-rater reliability of Cohen's kappa of 0.72 (95% CI, 0.42-1.01). Narrative synthesis and meta-analysis were used to assess intervention effectiveness. Meta-regression was used to assess whether factors such as intervention type, peer support, and ethnicity accounted for hetereogeneity. RESULTS: Thirteen studies were eligible for inclusion, with 1076 participants in control groups and 980 participants in intervention groups; 12 studies provided estimates for meta-analysis. All studies were from the United States. Interventions were associated with an overall mean reduction in depression in caregivers (SMD -0.17 (95% CI, -0.29 to -0.05; P = 0.005). Meta-regression did not indicate any potential sources of heterogeneity, although narrative synthesis suggested that interventions developed with the target ethnic minority group's preferred mode of engagement in mind alongside cultural adaptations may have enhanced effectiveness. CONCLUSIONS: Psychosocial interventions for depression in ethnic minority carers of people with dementia are effective and could be enhanced through cultural adaptations. High-quality studies targeting minority ethnic groups outside of the United States are needed.