Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder

Abstract

BackgroundEvidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder.MethodsAn estimated sixty patients will be enrolled in the study. Participants will be randomised to one of two conditions: CRT with treatment as usual (TAU), or TAU. CRT will consist of 42 individual sessions and 14 group sessions. The primary outcome measure for this study is change in cognitive functioning using the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include change in social and occupational functioning, disorganised symptoms, negative symptoms, violence, participation in psychosocial treatment and recovery. In addition to these effectiveness measures, we will examine patient satisfaction.DiscussionCognitive difficulties experienced by schizophrenia spectrum patients are associated with general functioning, ability to benefit from psychosocial interventions and quality of life. Research into the treatment of cognitive difficulties within a forensic setting is therefore an important priority. The results of the proposed study will help answer the question whether cognitive remediation improves functional outcomes in forensic mental health patients with schizophrenia or schizoaffective disorder. Forensic mental health patients are detained for the dual purpose of receiving treatment and for public protection. There can be conflict between these two roles perhaps causing forensic services to have an increased length of stay compared to general psychiatric admissions. Ultimately a focus on emphasising cognition and general functioning over symptoms may decrease tension between the core responsibilities of forensic mental health services.Trial RegistrationClinicalTrials.gov Identifier: NCT02360813. Trial registered Feb 4th 2015 and last updated May 1st 2015.

Prospective observational cohort study of ‘treatment as usual’ over four years for patients with schizophrenia in a national forensic hospital

“…Because many patients experience cognitive impairment and remain symptomatic even when adhering to pharmacotherapy we also investigated the impact of cognition and symptoms on treatment outcome [ 44 , 57 ]. Cognition accounted for 12.6% of the variance in mean DUNDRUM-3 change and when combined with symptoms the total model accounted for 19.2%.…”

“…Clinicians need to be aware of the impact that cognition and symptoms have on patients’ ability to participate in treatment. Patients may benefit from cognitive remediation therapy [ 57 ] and medication review [ 14 ] prior to commencing psychosocial interventions.…”

“…The DUNDRUM-3 programme completion scale deliberately does not require any specific manualized or other treatment programmes, since individual patients will have varying needs, and there is no current basis to prefer any one manualised programme over another. Nor is there evidence that manualised programmes are necessarily better than less structured programmes [ 17 ], when alternative structures may be more effective, including errorless learning and scaffolding [ 57 ]. Each of the seven items of the DUNDRUM-3 programme completion scale lists representative programmes where useful [ 18 , 31 , 56 ].…”

“…During the period studied, pillar I ‘physical health’ was managed in accordance with national standards [ 58 , 59 ] while other relevant standards have also been summarized [ 60 ]. This included a six-monthly full review by family practitioner and primary care nurse and access to a metabolic physician along with dentist, dietician, physiotherapy and other allied health professionals; pillar II ‘mental health’ programmes are based on internationally recognized treatment [ 61 ] and medication protocols [ 62 ] up-dated as appropriate in the light of evidence based guidance, the Wellness Recovery Action Plan [ 63 ] and a range of modern evidence-based psychotherapies including cognitive remediation [ 57 ], metacognitive therapy [ 64 ] and cognitive behaviour therapies; pillar III the ‘substance misuse recovery’ programme included a four session brief information group then an eight session education group [ 65 , 66 ], a full 28 session relapse prevention programme [ 67 ] and an aftercare self-help group; pillar IV ‘problem behaviours’ are delivered in the form of a self-risk management group programme which includes a 33 session first phase in six modules [ 68 ] and a second phase framework for behavioural analysis which typically includes an analysis of the most serious index offence in one to one work [ 69 ]; pillar V ‘self-care and activities of daily living’ are delivered in accordance with principles of the Model of Human Occupation (MOHO) [ 70 ]; pillar VI ‘education’ was delivered in accordance with national curricula while ‘occupation and creativity’ were delivered according to MOHO and educational principles; pillar VII ‘family and intimate relationship’ therapies were delivered variously by mental health social workers and trained family therapists.…”

Anticholinergic burden in schizophrenia and ability to benefit from psychosocial treatment programmes: a 3-year prospective cohort study

“…Psychosocial treatments are generally used to address the functional disability that characterizes schizophrenia (Grant et al 2011). Unfortunately cognitive problems may also interfere with the effectiveness of these interventions (Green et al 2000;Kurtz, 2011;O'Reilly et al 2016).…”