Cognitive Remediation Therapy Within a Secure Forensic Setting

July 24, 2017 updated by: Ken O'Reilly, Central Mental Hospital

Randomised Controlled Trial to Evaluate the Efficacy of Cognitive Remediation Within a Secure Forensic Setting for Schizophrenia Spectrum Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D 14
        • Central Mental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A Structured Clinical Interview for Diagnostic and Statistical Manual IV (SCID) diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:

  • Acutely psychotic, or judged too dangerous to participate in treatment, or being over 65 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Remediation Therapy
Principle driven cognitive remediation therapy, cognitive rehabilitation, cognitive training, cognitive enhancement.
Behavioral: Cognitive Remediation Therapy
Fifty-six sessions of principle driven cognitive remediation therapy. Three individual sessions and one group session each week for approximately fourteen weeks.
Other Names:
  • Cognitive training
  • Cognitive enhancement
  • Cognitive rehabilitation
Active Comparator: Treatment as Usual
Usual care.
Other: Treatment as usual
Keep getting usual care.
Other Names:
  • Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The MATRICS Consensus Cognitive Battery (MCCB)
Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)
Consensus neuropsychological assessment battery for cognitive deficits in schizophrenia
Group by time interaction: changes from baseline, to end of treatment (average 5 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social and Occupational Functioning Assessment Scale (SOFAS)
Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)
100 item rating scale for measuring real world functioning independent of symptoms
Group by time interaction: changes from baseline, to end of treatment (average 5 months)
Positive and Negative Syndrome Scale (negative and disorganized factors)
Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)
Rating scale for assessing psychiatric symptoms associated with schizophrenia
Group by time interaction: changes from baseline, to end of treatment (average 5 months)
Clinical Assessment Interview for Negative Symptoms (CAINS)
Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)
Rating scale for assessing the negative symptoms of schizophrenia
Group by time interaction: changes from baseline, to end of treatment (average 5 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Historical Clinical and Risk Management -20 (HCR-20)
Time Frame: Group by time interaction: changes from baseline, to 12 months
Rating scale for assessing violence risk
Group by time interaction: changes from baseline, to 12 months
Dundrum Toolkit: Programme Completion and Recovery Scales
Time Frame: Group by time interaction: changes from baseline to 12 months
Rating scale for assessing progress and recovery within a forensic mental health setting
Group by time interaction: changes from baseline to 12 months
Patient satisfaction.
Time Frame: Average 5 months.
Consumer developed interview exploring patient satisfaction with cognitive remediation.
Average 5 months.
Feasibility outcome: rate of enrolment.
Time Frame: 12 months.
Willingness of forensic mental health patients to participate in study.
12 months.
Feasibility outcome: rate of retention.
Time Frame: 12 months.
Number of patients who complete the intervention.
12 months.
Feasibility outcome: blinding.
Time Frame: 12 months.
Number of patients in which the blind is broken compared to number of patients in the study.
12 months.
Completion rate of primary outcome measures
Time Frame: 12 months.
Number of successfully completed primary outcome measures.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Mental Hospital

Investigators

  • Study Director: Professor Harry G Kennedy, M.D., Central Mental Hospital and Department of Psychiatry, Trinity College Dublin.
  • Study Director: Professor Gary Donohoe, Ph.D., Department of Psychiatry, Trinity College Dublin.
  • Principal Investigator: Dr. Ken W O'Reilly, D.Psych.Sc., Central Mental Hospital and Department of Psychiatry, Trinity College Dublin.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Central Mental Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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