|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02360813 |
|
Date of registration:
|
04/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Cognitive Remediation Therapy Within a Secure Forensic Setting
|
|
Scientific title:
|
Randomised Controlled Trial to Evaluate the Efficacy of Cognitive Remediation Within a Secure Forensic Setting for Schizophrenia Spectrum Patients |
|
Date of first enrolment:
|
August 2014 |
|
Target sample size:
|
65 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02360813 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Ireland
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr. Ken W O'Reilly, D.Psych.Sc. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Central Mental Hospital and Department of Psychiatry, Trinity College Dublin. |
|
|
Name:
|
Professor Gary Donohoe, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Psychiatry, Trinity College Dublin. |
|
|
Name:
|
Professor Harry G Kennedy, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Central Mental Hospital and Department of Psychiatry, Trinity College Dublin. |
|
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Schizoaffective Disorder
|
|
Schizophrenia
|
|
Cognitive Deficits
|
|
Intervention(s)
|
|
Behavioral: Cognitive Remediation Therapy
|
|
Other: Treatment as usual
|
|
Primary Outcome(s)
|
|
The MATRICS Consensus Cognitive Battery (MCCB)
[Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)]
|
|
Secondary Outcome(s)
|
|
Social and Occupational Functioning Assessment Scale (SOFAS)
[Time Frame: 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)]
|
|
Clinical Assessment Interview for Negative Symptoms (CAINS)
[Time Frame: Group by time interaction: changes from baseline, to end of treatment (average 5 months)]
|
|
Secondary ID(s)
|
|
Central Mental Hospital
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|