NCT02360813

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

February 4, 2015

Last Update Submit

July 24, 2017

Conditions

SchizophreniaSchizoaffective DisorderCognitive Deficits

Keywords

Cognitive remediation therapyPsychiatric rehabilitationForensic mental healthForensic psychiatryClinical psychologyRandomized controlled trialPrinciple driven interventionPsychological InterventionCognitive enhancement

Outcome Measures

Primary Outcomes (1)

  • The MATRICS Consensus Cognitive Battery (MCCB)

    Consensus neuropsychological assessment battery for cognitive deficits in schizophrenia

    Group by time interaction: changes from baseline, to end of treatment (average 5 months)

Secondary Outcomes (3)

  • Social and Occupational Functioning Assessment Scale (SOFAS)

    Group by time interaction: changes from baseline, to end of treatment (average 5 months)

  • Positive and Negative Syndrome Scale (negative and disorganized factors)

    Group by time interaction: changes from baseline, to end of treatment (average 5 months)

  • Clinical Assessment Interview for Negative Symptoms (CAINS)

    Group by time interaction: changes from baseline, to end of treatment (average 5 months)

Other Outcomes (7)

  • Historical Clinical and Risk Management -20 (HCR-20)

    Group by time interaction: changes from baseline, to 12 months

  • Dundrum Toolkit: Programme Completion and Recovery Scales

    Group by time interaction: changes from baseline to 12 months

  • Patient satisfaction.

    Average 5 months.

  • +4 more other outcomes

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL

Principle driven cognitive remediation therapy, cognitive rehabilitation, cognitive training, cognitive enhancement.

Behavioral: Cognitive Remediation Therapy

Treatment as Usual

ACTIVE COMPARATOR

Usual care.

Other: Treatment as usual

Interventions

Cognitive Remediation TherapyBEHAVIORAL

Fifty-six sessions of principle driven cognitive remediation therapy. Three individual sessions and one group session each week for approximately fourteen weeks.

Also known as: Cognitive training, Cognitive rehabilitation, Cognitive enhancement
Cognitive Remediation Therapy
Treatment as usualOTHER

Keep getting usual care.

Also known as: Standard care
Treatment as Usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Mental Hospital

Dublin, D 14, Ireland

Location

Related Publications (10)

  • 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.

    PMID: 18172019BACKGROUND

  • Rybarczyk B. (2011). Social and Occupational Functioning Assessment Scale (SOFAS). Encyclopedia of Clinical Neuropsychology. p 2313

    BACKGROUND

  • 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.

    PMID: 3616518BACKGROUND

  • 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.

    PMID: 23377637BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 23837697BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21406461BACKGROUND

  • 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.

    PMID: 30646884DERIVED

  • 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.

    PMID: 26759167DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersCognition Disorders

Interventions

Cognitive TrainingTherapeuticsStandard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • 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.

    STUDY DIRECTOR

  • Dr. Ken W O'Reilly, D.Psych.Sc.

    Central Mental Hospital and Department of Psychiatry, Trinity College Dublin.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ken O'Reilly. Senior Clinical Psychologist

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 11, 2015

Study Start

August 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

IE(1)