Cognitive Remediation Therapy Within a Secure Forensic Setting
NCT ID: NCT02360813
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2014-08-31
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Remediation Therapy
Principle driven cognitive remediation therapy, cognitive rehabilitation, cognitive training, cognitive enhancement.
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.
Treatment as Usual
Usual care.
Treatment as usual
Keep getting usual care.
Interventions
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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.
Treatment as usual
Keep getting usual care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Central Mental Hospital
OTHER_GOV
Responsible Party
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Ken O'Reilly
Dr Ken O'Reilly. Senior Clinical Psychologist
Principal Investigators
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Professor Harry G Kennedy, M.D.
Role: STUDY_DIRECTOR
Central Mental Hospital and Department of Psychiatry, Trinity College Dublin.
Professor Gary Donohoe, Ph.D.
Role: STUDY_DIRECTOR
Department of Psychiatry, Trinity College Dublin.
Dr. Ken W O'Reilly, D.Psych.Sc.
Role: PRINCIPAL_INVESTIGATOR
Central Mental Hospital and Department of Psychiatry, Trinity College Dublin.
Locations
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Central Mental Hospital
Dublin, , Ireland
Countries
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References
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Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.
Rybarczyk B. (2011). Social and Occupational Functioning Assessment Scale (SOFAS). Encyclopedia of Clinical Neuropsychology. p 2313
Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
Kring AM, Gur RE, Blanchard JJ, Horan WP, Reise SP. The Clinical Assessment Interview for Negative Symptoms (CAINS): final development and validation. Am J Psychiatry. 2013 Feb;170(2):165-72. doi: 10.1176/appi.ajp.2012.12010109.
Webster CD, Douglas KS, Eaves D, Hart SD. HCR-20: assessing risk for violence. Burnaby: Mental Health Law and Policy Institute, Simon Fraser University; 1997.
Davoren M, Abidin Z, Naughton L, Gibbons O, Nulty A, Wright B, Kennedy HG. Prospective study of factors influencing conditional discharge from a forensic hospital: the DUNDRUM-3 programme completion and DUNDRUM-4 recovery structured professional judgement instruments and risk. BMC Psychiatry. 2013 Jul 9;13:185. doi: 10.1186/1471-244X-13-185.
Rose D, Wykes T, Farrier D, Doran AM, Sporel T & Bogner D (2008) What Do Clients Think of Cognitive Remediation Therapy?: A Consumer-Led Investigation of Satisfaction and Side Effects, American Journal of Psychiatric Rehabilitation. Rehabilitation, 11:2, 181-204.
Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
O'Reilly K, Donohoe G, O'Sullivan D, Coyle C, Corvin A, O'Flynn P, O'Donnell M, Galligan T, O'Connell P, Kennedy HG. A randomized controlled trial of cognitive remediation for a national cohort of forensic patients with schizophrenia or schizoaffective disorder. BMC Psychiatry. 2019 Jan 15;19(1):27. doi: 10.1186/s12888-019-2018-6.
O'Reilly K, Donohoe G, O'Sullivan D, Coyle C, Mullaney R, O'Connell P, Maddock C, Nulty A, O'Flynn P, O'Connell C, Kennedy HG. Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder. BMC Psychiatry. 2016 Jan 13;16:5. doi: 10.1186/s12888-016-0707-y.
Other Identifiers
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Central Mental Hospital
Identifier Type: -
Identifier Source: org_study_id
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