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BACKGROUND: Cognitive impairments are an emerging treatment target in mood disorders but currently there are no evidence-based pro-cognitive treatments indicated for patients in remission. With this systematic review of randomised controlled trials (RCTs), the International Society for Bipolar Disorders (ISBD) Targeting Cognition Task force provides an update of the most promising treatments and methodological recommendations.; METHODS: The review included RCTs of candidate pro-cognitive interventions in fully or partially remitted patients with major depressive disorder or bipolar disorder. We followed the procedures of the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) 2020 statement. Searches were conducted on PubMed/MEDLINE, PsycInfo, EMBASE and Cochrane Library from January 2015, when two prior systematic reviews were conducted, until February 2021. Two independent authors reviewed the studies with the Revised Cochrane Collaboration's Risk of Bias tool for Randomised trials.; RESULTS: We identified 16 RCTs (N=859) investigating cognitive remediation (CR; k=6; N=311), direct current or repetitive magnetic stimulation (k=3; N=127), or pharmacological interventions (k=7; N=421). CR showed most consistent cognitive benefits, with two trials showing improvements on primary outcomes. Neuromodulatory interventions revealed no clear efficacy. Among pharmacological interventions, modafinil and lurasidone showed early positive results. Sources of bias included small samples, lack of pre-screening for objective cognitive impairment, no primary outcome, and no information on allocation sequence masking.; CONCLUSIONS: Evidence for pro-cognitive treatments in mood disorders is emerging. Recommendations are to increase sample sizes, pre-screen for impairment in targeted domain(s), select one primary outcome, aid transfer to real-world functioning, investigate multimodal interventions, and include neuroimaging. This article is protected by copyright. All rights reserved.

Introduction Pregnancy and the first few years of a child’s life are important windows of opportunity in which to equalize life chances. A Better Start (ABS) is an area-based intervention being delivered in five areas of socioeconomic disadvantage across England. This protocol describes an evaluation of the impact and cost-effectiveness of ABS. Methods and analysis The evaluation of ABS comprises a mixed-methods design including impact, cost effectiveness and process components. It involves a cohort study in the five ABS areas and 15 matched comparison sites (n=2885), beginning in pregnancy in 2017 and ending in 2024 when the child is age 7, with a separate cross-sectional baseline survey in 2016/17. Process data will include a profiling of the structure and services being provided in the five ABS sites at baseline and yearly thereafter, and data regarding the participating families and the services that they receive. Eligible participants will include pregnant women living within the designated sites, with recruitment beginning at 16 weeks of pregnancy. Data collection will involve interviewer-administered and self-completion surveys at eight time-points. Primary outcomes include nutrition, socio-emotional development, speech, language and learning. Data analysis will include the use of propensity score techniques to construct matched programme and comparison groups, and a range of statistical techniques to calculate the difference in differences between the intervention and comparison groups. The economic evaluation will involve a within-cohort study economic evaluation to compare individual-level costs and outcomes, and a decision analytic cost-effectiveness model to estimate the expected incremental cost per unit change in primary outcomes for ABS in comparison to usual care. Ethics and dissemination Ethical approval to conduct the study has been obtained. The learning and dissemination workstream involves working within and across the sites to generate learning via communities of practice and a range of learning and dissemination events. STRENGTHS AND LIMITATIONS OF STUDY • The study involves a large longitudinal design with matched comparison sites • The designation of ABS areas was not random, and statistical matching will be used to select comparison areas and propensity score techniques will be used to match individual in ABS areas to individuals in comparison areas • Concurrent implementation data will provide important information about systems level change • Recruitment in pregnancy of disadvantaged women will present many difficulties and uptake may be low • Loss to follow-up by 7 years may be high