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Trial registered on ANZCTR


Registration number
ACTRN12618000161224
Ethics application status
Approved
Date submitted
11/01/2018
Date registered
2/02/2018
Date last updated
2/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing two approaches (Cogsmart and CirCuits) to improving the cognitive deficits of people diagnosed with psychosis.
Scientific title
Randomised control trial of Cognitive compensatory training (Cogsmart) and a ccomputerised cognitive remediation program, CirCuits in people diagnosed with a schizophrenia spectrum disorder with the aim of improving community functioning.
Secondary ID [1] 293758 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia spectrum disorder 306142 0
Condition category
Condition code
Mental Health 305257 305257 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary goal of addressing cognitive deficits is to improve real world functioning. Cogsmart ( Cognitive Symptom Management and Rehabilitation Therapy) will be delivered once a week for 2 hours for 12 weeks. It is a manualised cognitive compensatory training program that focusses on the use of strategies to improve real world cognitive functioning ( Zaidman, Sofia Rae, "Pilot Testing CogSMART: A Novel, Compensatory Program of Cognitive Remediation for Psychosis developed by Elizabeth W. Twamley, PhD" (2016). Honors Theses). It will be delivered in 2hour weekly sessions for 12 weeks in groups of up to 8 participants with one facilitator who is trained as a cognitive remediation facilitator. The 12 modules are 1. Introduction to calendars;2. Prospective memory;3 Short term prospective memory;4. Conversational attention; 5. Task attention;6,7,8 Verbal learning and memory; 9,10,11. Cognitive flexibility and problem solving; 12 Skills integration, review and next steps. Participants have their own manual to assist with remembering sessions and homework practice.
Intervention code [1] 300011 0
Rehabilitation
Intervention code [2] 300058 0
Treatment: Other
Comparator / control treatment
Non inferiority trial comparing Cogsmart and CirCuits with primary outcome being improvement in social functioning
CIRCuiTS (Computerised Interactive Remediation of Cognition – Training for Schizophrenia). This is a modular package including tasks of a wide range of cognitive functions (particularly executive function and memory), designed to allow therapy programmes to be flexibly designed to incorporate only relevant tasks. The sessions are 1 hour twice a week for 12 weeks. Computer based program has cognitive tasks are embedded in a real world ”village” context. Abstract tasks eg decoding are combined with ecologically valid tasks eg shopping and are designed to exercise attention, memory and planning. The participants are asked to nominate strategies that they will use and after completing the tasks, rate how useful the strategies were. Sessions are delivered twice weekly for an hour and are facilitated by a mental health clinician trained as a cognitive remediation facilitator. The sessions occur in groups of up to 8 participants.
Control group
Active

Outcomes
Primary outcome [1] 304409 0
Real world functioning in people with schizophrenia spectrum disorders, as measured using the Social functioning scale (SFS), compared to a computerused cognitive remediation program, CirCuits.
Timepoint [1] 304409 0
.To assess real world functioning as measured using the SFS 12 and 24 weeks following program commencement
Secondary outcome [1] 341869 0
To assess subjective sense of cognitive functioning using the (SSTICS)
Timepoint [1] 341869 0
SSTICS at baseline, 12 and 24 weeks following commencement of the program
Secondary outcome [2] 342662 0
To assess cognitive functioning of participants using the BACS
Timepoint [2] 342662 0
BACS at baseline, 12 weeks and 24 weeks following commencement of the program

Eligibility
Key inclusion criteria
Patients will be invited to participate in the study if they meet all of the following criteria:
1. Participants can be of either gender, and of any ethnic background
2. Aged between 18 and 65 years (inclusive)
3. Fulfil the DSM V criteria for schizophrenia spectrum disorder and with impaired social functioning based on the Diagnostic Interview for Psychosis (DIP)
4. Absence of uncorrected sensory impairments
5. English literacy skills > grade 4 as per years of education
6. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. Substance dependence (with the exception of tobacco) based on the current time point using the Diagnostic Interview for Psychosis (DIP)
2. Intellectual handicap (estimated full-scale IQ<70)
3. People who are unable to understand or communicate in English
4. English literacy skills < grade 4 as per years of education
5. Comorbid physical illnesses that would impair the participants’ ability to complete the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be done centrally by administrative staff who notify the program PI by email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised once written consent has been obtained and the baseline assessments have been completed. Participants will be randomised to one of the treatment groups by a research staff not involved in therapy delivery, using blocks of 4 via a computer-generated randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will be conducted in accordance with the International Conference on Harmonization E9 statistical principles, and are based on all randomised participants with at least one post-baseline observation (intention to treat population). Reporting of research findings will be done in accordance to CONSORT guidelines. The primary efficacy analysis will assess average treatment group differences for the primary outcome measure SFS, over the entire study period (baseline, endpoint, follow-up) and will use a likelihood based mixed-effects model, repeated measures approach (MMRM). The MMRM model includes the fixed, categorical effects of treatment (Cogsmart or Circuits), visit (baseline, 12 and 24 weeks), and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction. The MMRM includes all available data at each time point and is the preferred method of analyzing clinical trial data in psychiatry as compared to more traditional repeated measures analysis of variance (ANOVA) and analysis of covariance models (ANCOVA). Planned comparisons will be done with the MMRM models to determine between group differences in change of symptoms measures from baseline to week 12 and 24. Results from the analysis of dichotomous data will be presented as proportions, with 95% confidence interval, and Fisher’s exact p-value where appropriate. Non-parametric statistics will be used when assumptions for parametric methods are violated. Effect sizes will be calculated using Cohen’s guidelines. All tests of treatment effects will be conducted using a two-sided alpha level of 0.05 and 95% confidence intervals.
The main analyses will follow standard Intention to Treat (ITT) principals, where participants who drop out prior to the 12 week endpoint will have their Last Observation Carried Forward (LOCF). However, mindful that we expect a certain proportion of patients to drop out prior to completion (approximately 17%), we plan to undertake a Per Protocol (PP) secondary analyses. For this analyses, we will explore the impact of Cogsmart versus Cogsmart on the subset of respondents that completed at least 6 weeks of treatment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2017
Date of last participant enrolment
Anticipated
26/06/2019
Actual
Date of last data collection
Anticipated
26/03/2020
Actual
Sample size
Target
100
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9729 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 18506 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 298373 0
Hospital
Name [1] 298373 0
Metro South Addiction and MentalHealth Rehabilitation Academic Clinical unit
Country [1] 298373 0
Australia
Primary sponsor type
Hospital
Name
Metro South Addictions and Mental Health service
Address
Woolloongabba Community Clinic
228 Logan Rd Woolloongabba, Brisbane QLD 4102
Country
Australia
Secondary sponsor category [1] 297498 0
None
Name [1] 297498 0
Address [1] 297498 0
Country [1] 297498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299366 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 299366 0
Level 7 TRI Building
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba, Brisbane QLD4102
Ethics committee country [1] 299366 0
Australia
Date submitted for ethics approval [1] 299366 0
09/05/2017
Approval date [1] 299366 0
23/05/2017
Ethics approval number [1] 299366 0
HREC/17/QPAH/296

Summary
Brief summary
This clinical trial will look at which of the two therapies works best in improving thinking skills (e.g. memory and attention) which influence real world functioning.

The two therapies are Cognitive Symptom Management and Rehabilitation Therapy (Cogsmart) and Computerised Interactive Remediation of Cognition – Training for Schizophrenia (CIRCuiTS).

Cogmsart is a group therapy that aims to improve real world thinking skills for functioning. CIRCuiTS is a computerized program with modules including tasks of a wide range of cognitive functions. It also includes “bridging” were participants in the group reflect on how the program relates to thinking skills needed in real world functioning.

What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this clinical trial; however your participation will help us better understand if Cogsmart and CIRCuiTS are effective in improves thinking skills that help in every day functioning for people who suffer from psychosis.
What does participation in the study involve?
This clinical trial will randomise participants in a 1:1 design, which means there is an equal chance of being in either the Cogsmart or CIRcuiTS group.

Step 1 Screening Process
To determine Initial study eligibility you will partake in a screening interview which will take approximately 30 minutes.

Step 2 Contact
You will be asked to attend group sessions either once a week for 12 weeks, with each session lasting approximately 2 hours, or twice per week for 12 weeks, with each session lasting approximately 1 hour. You will also be asked to attend three sessions as an individual.

At each individual session a clinical trial research assistant/psychologist will conduct a series of clinical assessments. This will involve asking questions about your thinking and problem solving skills, thoughts, symptoms, and relationships.


Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2334 2334 0 0
/AnzctrAttachments/374284-cogsmart protocol.doc (Protocol)
Attachments [2] 2335 2335 0 0
/AnzctrAttachments/374284-COGSMART VS CIRCUITS Flyer 1 0.docx

Contacts
Principal investigator
Name 80194 0
Dr Frances Dark
Address 80194 0
Woolloongabba Community Clinic
228 Logan Rd
Woolloongabba QLD 4102
Country 80194 0
Australia
Phone 80194 0
+61 7 33171129
Fax 80194 0
Email 80194 0
[email protected]
Contact person for public queries
Name 80195 0
Frances Dark
Address 80195 0
Woolloongabba Community Clinic
228 Logan Rd
Woolloongabba QLD 4102
Country 80195 0
Australia
Phone 80195 0
+61 7 33171129
Fax 80195 0
Email 80195 0
[email protected]
Contact person for scientific queries
Name 80196 0
Frances Dark
Address 80196 0
Woolloongabba Community Clinic
228 Logan Rd
Woolloongabba QLD 4102
Country 80196 0
Australia
Phone 80196 0
+61 7 33171129
Fax 80196 0
Email 80196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme.2020https://dx.doi.org/10.1186/s13063-020-04743-y
N.B. These documents automatically identified may not have been verified by the study sponsor.