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. 2020 Jan 19;10(1):e035073.
doi: 10.1136/bmjopen-2019-035073.

Psychosocial treatments for relapse prevention in schizophrenia: study protocol for a systematic review and network meta-analysis of randomised evidence

Irene Bighelli  1 , Alessandro Rodolico  2 , Gabi Pitschel-Walz  3 , Wulf-Peter Hansen  4 , Corrado Barbui  5 , Toshi A Furukawa  6 , Georgia Salanti  7 , Stefan Leucht  3
Affiliations

Psychosocial treatments for relapse prevention in schizophrenia: study protocol for a systematic review and network meta-analysis of randomised evidence

Irene Bighelli et al. BMJ Open. .

Abstract

Introduction: There is evidence that different psychosocial interventions could reduce the risk of relapse in schizophrenia, but a comprehensive evidence based on their relative efficacy is lacking. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs) to rank psychosocial treatments for relapse prevention in schizophrenia according to their efficacy, acceptability and tolerability.

Methods and analysis: We will include all RCTs comparing a psychosocial treatment aimed at preventing relapse in patients with schizophrenia with another psychosocial intervention or with a no treatment condition (waiting list, treatment as usual). We will include studies on adult patients with schizophrenia, excluding specific subpopulations (eg, acutely ill patients). Primary outcome will be the number of patients experiencing a relapse. Secondary outcomes will be acceptability (dropout), change in overall, positive, negative and depressive symptoms, quality of life, adherence, functioning and adverse events. Published and unpublished studies will be sought through database searches, trial registries and websites. Study selection and data extraction will be conducted by at least two independent reviewers. We will conduct random-effects NMA to synthesise all evidence for each outcome and obtain a comprehensive ranking of all treatments. NMA will be conducted in R within a frequentist framework. The risk of bias in studies will be evaluated using the Cochrane Risk of Bias tool and the credibility of the evidence will be evaluated using Confidence in Network Meta-Analysis (CINeMA). Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.

Ethics and dissemination: No ethical issues are foreseen. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.

Prospero registration number: CRD42019147884.

Keywords: adult psychiatry; schizophrenia & psychotic disorders; statistics & research methods.

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Conflict of interest statement

Competing interests: SL has received honoraria as a consultant/advisor and/or for lectures from LB Pharma, Otsuka, Lundbeck, Boehringer Ingelheim, LTS Lohmann, Janssen, Johnson and Johnson, TEVA, MSD, Sandoz, SanofiAventis, Angelini, Sunovion, Recordati and Gedeon Richter. TAF reports personal fees from Meiji, Mitsubishi-Tanabe, MSD and Pfizer and a grant from Mitsubishi-Tanabe, outside the submitted work, and has a patent 2018-1 77 688 pending.

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