Cognitive Remediation Therapy Within a Secure Forensic Setting
Condition: Schizophrenia; Schizoaffective Disorder; Cognitive Deficits
MeSH terms: Schizophrenia; Psychotic Disorders; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This clinical trial tests the feasibility, effectiveness and patient satisfaction with
      cognitive remediation therapy for patients diagnosed with schizophrenia or schizoaffective
      disorder within a forensic hospital. It is hypothesised that patients receiving cognitive
      remediation therapy will have an improvement in cognitive performance, real world
      functioning, symptoms, violence risk and benefit more from additional psychosocial treatment
      programmes over time relative to patients receiving treatment as usual. Furthermore it is
      hypothesised that it will be feasible to carry out such a study and that patients will report
      high rates of satisfaction with cognitive remediation therapy. Finally it is hypothesised
      that differences on the effectiveness measures will be maintained at 6 month follow up after
      the end of treatment.
    

Detailed description: 
      This is a single centre randomised clinical trial to evaluate the feasibility, effectiveness
      and patient satisfaction with cognitive remediation therapy within a secure forensic setting
      for patients diagnosed with schizophrenia or schizoaffective disorder.

      The feasibility of the intervention will be assessed using key indicators such as rate of
      enrolment, retention of patients in the trial, blinding effectiveness, and completion rate of
      the primary outcome measure. The effectiveness of the intervention will be assessed using the
      MATRICS consensus cognitive battery, symptoms (PANSS and CAINS) and real world functioning
      (SOFAS: Social and occupational functioning assessment scale). The effect of cognitive
      remediation on violence risk (HCR-20), programme completion and recovery (Dundrum 3 & 4) will
      also be examined, where programme completion is a measure of attainments from participating
      in additional psychosocial interventions and recovery is a measure of stability of mental
      state.

      Patient satisfaction with cognitive remediation therapy will be assessed using a consumer
      constructed interview developed by Rose et al (2008) and administered by a social worker not
      involved in the delivery of cognitive remediation.

      The trial will take place at the Republic of Ireland's Central Mental Hospital (CMH). The CMH
      is the only secure forensic psychiatric hospital for the Republic of Ireland, a population of
      4.6 million. CMH provides specialised care for adults who have a mental disorder and are at
      risk of harming themselves or others.

      After a baseline assessment to ensure eligibility and to obtain consent, an estimated 60
      patients will be randomised to receive fourteen weeks of cognitive remediation versus
      treatment as usual. Patients who receive treatment as usual will be offered cognitive
      remediation upon completion of the study. Patients allocated to cognitive remediation will
      receive three individual sessions of cognitive remediation a week and one group session,
      fifty-six sessions in total The focus of the group session is to normalise cognitive
      difficulties that patients may be experiencing, to receive support and to help generalise
      gains. The primary outcome measure the MATRICS composite score and secondary outcome measures
      to assess real world functioning, symptoms, violence risk, programme completion and recovery
      will be administered at baseline, the end of treatment and at six month follow up. Secondary
      measures will also include feasibility outcomes and patient satisfaction with cognitive
      remediation therapy. All evaluators of the effectiveness measures will be blind to
      participant treatment condition at the time of assessment.

      The cognitive remediation therapy is a principle driven intervention consisting of nine
      treatment principles: Principle 1 refers to relationship building, Principle 2 refers to
      collaborative goal setting, Principle 3 involves the session structure, Principle 4 concerns
      the content of the sessions, Principle 5, concerns the pacing of sessions, Principle 6
      involves scaffolding and errorless learning, Principle 7 refers to meta-cognitive strategies,
      Principle 8 involves generalisation of gains, finally Principle 9 refers to managing
      ambivalence. The actual therapy will involve the use of a combination on pen, paper and
      computerised materials to stimulate patient's cognitive capacity and to provide them with the
      opportunity to apply meta-cognitive strategies.

      The investigators hypothesise that it is feasible to carry out a randomised controlled trial
      within a single centre forensic setting and that patients will report high rates of
      satisfaction with cognitive remediation. It is also hypothesised that patients receiving
      cognitive remediation therapy will have an improvement in cognitive performance (the primary
      outcome measure), real world functioning, symptoms and violence risk over time relative to
      patients receiving treatment as usual; specifically that there will be a treatment by time
      interaction. Furthermore it is hypothesised that these differences will be maintained at six
      month follow up after the end of treatment.

      In addition it is hypothesised that patients receiving cognitive remediation will show an
      improvement over time on the Dundrum programme completion and recovery scales compared to
      those receiving treatment as usual.

      While meta-analytic reviews have demonstrated that cognitive remediation therapy has a
      beneficial effect on the cognitive deficits experienced by patients with schizophrenia (Wykes
      et al 2011), to the best of our knowledge there has been no study with forensic mental health
      patients. The current study will help answer whether it is feasible to deliver cognitive
      remediation within a forensic mental health setting and whether it is acceptable to patients.
      The study aims to contribute to the evidence base for psychological interventions within a
      forensic setting and to answer the question as to whether cognitive remediation has a
      beneficial effect and if it does whether this effect is maintained over time.
    

Intervention name(s): Cognitive Remediation Therapy; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): Fifty-six sessions of principle driven cognitive remediation therapy. Three individual sessions and one group session each week for approximately fourteen weeks.; Keep getting usual care.
Other intervention name(s): Cognitive training; Cognitive rehabilitation; Cognitive enhancement; Standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive remediation therapy; Psychiatric rehabilitation; Forensic mental health; Forensic psychiatry; Clinical psychology; Randomized controlled trial; Principle driven intervention; Psychological Intervention; Cognitive enhancement