A randomized controlled trial of cognitive remediation for a national cohort of forensic patients with schizophrenia or schizoaffective disorder

Abstract

Background: Evidence is accumulating that Cognitive Remediation Training (CRT) is effective for ameliorating cognitive deficits experienced by patients with schizophrenia and accompanying functional impairment. There has been no randomized controlled trial of CRT using a nationally representative population of forensic patients, despite the significant cognitive deficits frequently present within this group.

Methods: Sixty-five patients with schizophrenia or schizoaffective disorder were enrolled in a single blind randomized controlled trial of CRT versus treatment as usual (TAU); representing 94% of those eligible within a national forensic cohort. The primary outcome measure was the composite score of the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcome measures included neurocognitive and social cognitive domains, symptoms, and 'real world' functioning. Patient satisfaction was examined using an exit interview. Participants were reassessed at 8 months follow up. All data were analyzed using an intention to treat design (ITT).

Results: For the primary outcome measure, the MCCB composite score, there were significant differences between those who participated in CRT and those receiving TAU at both end of treatment and 8 months follow up (Cohen's d = 0.34. Significant improvements were observed in visual and working memory. Mediation analysis found that those who cognitively benefited from CRT had corresponding improved functioning, and more net positive therapeutic moves i.e. moves to units with lower security within the hospital. Ninety-six percent believed their cognitive gains positively affected their daily lives.

Conclusions: CRT may be an acceptable and efficacious intervention for forensic patients with schizophrenia or schizoaffective disorder.

Trial registration: ClinicalTrials.gov Identifier: NCT02360813 . Trial registered Feb 4th 2015, last updated May 1st 2015.

Keywords: CRT; Clinical trial; Cognitive remediation training; Effectiveness; Forensic mental health; Neurocognition; Schizophrenia.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the research ethics and effectiveness committee of the NFMHS (AREE/290814, 29th August 2014) and Faculty of Health Sciences Research Ethics committee Trinity College Dublin (8th September 2014). The study complied with the Helsinki Declaration of 1975, revised in 2008. All participants were assessed by their treating consultant psychiatrists as having the capacity to consent to the research study. All participants were supplied with a written letter of information concerning the study. After a period of 7 days, all gave written, informed, and competent consent in keeping with the approval of the research ethics committees.

Consent for publication

This manuscript does not contain any individual person’s data which could be readily identifiable in any form (including any individual details, images or videos) i.e. no individually identifiable material was included. And all patients gave consent to publish the study's findings.

Competing interests

All authors declare that they have no financial involvement (including employment, fees, share ownership) or affiliation with any organization whose financial interests may be affected by material in the manuscript, or which might potentially bias it. HGK is a member of the editorial board of BMC Psychiatry but has had no editorial involvement with the publication of this article.

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Figures

Fig. 1

CONSORT flow diagram