Protocol for individual participant data meta-analysis of randomised controlled trials of patients with psychosis to investigate treatment effect modifiers for CBT versus treatment as usual or other psychosocial interventions

Maria Sudell, Catrin Tudur-Smith, Xiaomeng Liao, Eleanor Longden, Graham Dunn, Tim Kendall, Richard Emsley, Anthony Morrison, Filippo Varese

Research output: Contribution to journalComment/debatepeer-review

1 Citation (Scopus)

Abstract

INTRODUCTION: Aggregate data meta-analyses have shown heterogeneous treatment effects for cognitive-behavioural therapy (CBT) for patients with schizophrenia spectrum diagnoses. This heterogeneity could stem from specific intervention or patient characteristics that could influence the clinical effectiveness of CBT, termed treatment effect modifiers. This individual participant data meta-analysis will investigate a range of potential treatment effect modifiers of the efficacy of CBT.

METHODS AND ANALYSIS: We will perform a systematic review and meta-analysis of studies investigating CBT versus treatment as usual, or CBT versus other psychosocial interventions, for patients with schizophrenia spectrum diagnoses. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE and the online clinical trials registers of the US government, European Union, WHO and Current Controlled Trials will be searched. Two researchers will screen titles and abstracts identified by the search. Individual participant data will be requested for any eligible study, for the primary outcome (overall psychotic symptoms), secondary outcomes and treatment effect modifiers. Data will be checked and recoded according to an established statistical analysis plan. One-stage and two-stage random effects meta-analyses investigating potential treatment effect modifiers will be conducted. A list of potential treatment effect modifiers for CBT will be produced, motivating future research into particular modifiers.

ETHICS AND DISSEMINATION: This study does not require ethical approval as it is based on data from existing studies, although best ethical practice for secondary analysis of clinical data will be followed. The findings will be submitted for publication in peer-reviewed journals, and promoted to relevant stakeholders.

PROSPERO REGISTRATION NUMBER: CRD42017060068.

Original languageEnglish
Article numbere035062
JournalBMJ Open
Volume11
Issue number5
DOIs
Publication statusPublished - 28 May 2021

Keywords

  • Cognitive Behavioral Therapy
  • Humans
  • Meta-Analysis as Topic
  • Psychosocial Intervention
  • Psychotic Disorders/therapy
  • Systematic Reviews as Topic
  • Treatment Outcome

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