Title: Evaluating the effectiveness and cost effectiveness of BSL (British Sign Language) IAPT (Improving Access to Psychological Therapies)
Funder: Department of Health (England)

Abstract: Background: IAPT (Improving Access to Psychological Therapies) is a national (England) NHS programme for rolling out NICE approved psychological interventions to manage mental health problems (principally depression and anxiety) in primary care. BSL-IAPT is an adapted version to meet the cultural and linguistic needs of Deaf people who use British Sign Language (generally marked by a capital ‘D’ to distinguish them from the larger population of people who might lose their hearing through the life-course who use spoken language or who define deafness as a primarily medical condition requiring rehabilitation). BSL-IAPT is delivered by sign language users (mostly Deaf) and uses IAPT standard assessment and outcome measures translated into BSL (British Sign Language) and tested for reliability. Originally offered in 2 health authorities from April 2013 it was offered in 5. Throughout the rest of England Deaf people access standard IAPT usually via interpreters; assessments do not follow a standard translation with established reliability. Research questions: 1. Is BSL-IAPT more effective than standard IAPT for Deaf people with anxiety and depression? 2. Is any additional benefit from BSL-IAPT worth any additional cost to provide it?Research Design: Phase I Modelling. We will (i) investigate the acceptability of randomisation amongst Deaf service users using focus groups and survey methods in BSL; (ii) map likely numbers of users of BSL IAPT and Deaf users of standard IAPT who would be eligible for recruitment using secondary data analysis of the national IAPT data base; (iii) compare the previous outcomes of Deaf people using either BSL-IAPT or standard IAPT to estimate recruitment targets should a full trial be indicated using secondary analysis of the national IAPT data base; (iv) establish the clinical cut offs for the BSL IAPT assessment tools (PHQ-9 GAD-7 WSAS). Pre-existing data on 85 Deaf people with no mental health difficulties who completed the BSL versions of the IAPT assessment tools (PHQ-9 GAD-7 and WSAS) in our previous study will be compared with data from service users who have completed the same assessments as BSL-IAPT patients . We will calculate an AUC value sensitivity specificity positive predicted value (ppv) negative predicted value (npv). Bootstrapping of the sample will estimate variability for the cut-off values and for the AUCs and obtain details of the clinical cut-off & AUC from previously published work on IAPT to estimate variability of measures. We will establish whether there is a statistically significant difference between the clinical cut-off values (BSL-PHQ-9 vs PHQ-9; BSL-GAD-7 vs GAD-7; BSL-WSAS vs WSAS); (v) produce a replicable description of ‘standard IAPT’ when implemented with BSL users though a structured survey of standard IAPT practitioners; (vi) translate and test the reliability of a BSL version of the EQ-5D with volunteers using an on-line data capture in BSL; (vii) identify key items of service use and develop data collection forms for economic analysis. An economic model will synthesise data from the database and published literature to explore the potential costs of health and social care and quality adjusted life years (QALYs) from a societal perspective. Health status and QALYs will be estimated from the EQ-5D which will be translated into BSL piloted and its reliability tested. Primary and secondary economic analyses will estimate incremental cost effectiveness ratios cost effectiveness acceptability curves and net benefit statistics of BSL-IAPT compared to usual care only. Completion of this phase will enable us to establish whether a randomised controlled trial could be undertaken to address our principle research questions.Stop point: The research study will stop at this point if Phase I demonstrates randomisation is not acceptable AND one or more of the following apply: (i) The number of Deaf people accessing standard IAPT is shown to be too small for a comparative/two arm study to be feasible; (ii) The degree of variability in service delivery to Deaf people accessing standard IAPT is too great to model it as a coherent intervention;(iii)The populations of Deaf people using BSL IAPT and standard IAPT are not comparable. It may continue using a non-randomised design should all of the following apply: (i) The number of Deaf People accessing standard IAPT is shown to be great enough for a comparative matched case control design to be feasible; (ii) The degree of variability in service delivery to Deaf people accessing standard IAPT can be modelled and accounted for; (iii) The populations of Deaf people using BSL IAPT and standard IAPT are comparable.Phase II (feasibility study). Phase I indicates an RCT design we will implement a pilot trial to explore whether an RCT can be successfully carried out. If phase I indicates an RCT is not feasible we will implement a pilot of a non-randomised study using a matched case control design whereby the two groups of participants (Deaf users of BSL-IAPT and Deaf users of standard IAPT) will be matched across relevant demographic covariates. In both instances the objectives remain the same. We will recruit 30 patients to each arm of study and (i) test the feasibility of recruitment and retention of participants and centres including the development of culturally appropriate recruitment materials in BSL; (ii) determine whether recruitment targets required for a full trial/scaled up evaluation can be met within an acceptable timescale; (iii) refine the sample size and power calculation for a large scale study/trial by estimating the attrition rate; (iv) investigate the acceptability and adherence to data collection protocols in the diversity of settings associated with both BSL IAPT and standard IAPT through investigating fidelity to protocol; (v) use trial and model based analyses to explore the potential cost effectiveness of BSL-IAPT and identify key cost drivers. Main benefits to the NHS: BSL-IAPT addresses a significant inequality in access to services and persistently poor mental health outcomes in the Deaf population. The study will provide an evidence base for decision making about whether the adapted provision best addresses this need is cost effective and should be extended nationally.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: EAR;MENTAL HEALTH