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Trial registered on ANZCTR


Registration number
ACTRN12616000866404
Ethics application status
Approved
Date submitted
22/06/2016
Date registered
4/07/2016
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Date results information initially provided
31/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of Social Skills Training (SCIT) in those diagnosed with psychosis.
Scientific title
A randomised control trial on the effect of Social Cognition Interaction Training (SCIT) on social functioning in those diagnosed with psychosis.
Secondary ID [1] 289473 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 299154 0
Schizophrenia 299258 0
Schizophreniform psychosis 299259 0
Delusional disorder 299260 0
Bipolar disorder 299261 0
Psychosis not otherwise specified 299262 0
Condition category
Condition code
Mental Health 299173 299173 0 0
Psychosis and personality disorders
Mental Health 299174 299174 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will include 128 individuals diagnosed with psychosis who will be randomised to either a befriending program (comparison group) or the SCIT program (intervention). Participants will attend weekly, 2 hour face-to-face group sessions (2 facilitators, 6-8 participants) for 12 weeks at an inner city community mental health clinic. This will be in addition to participants' normal routine care.

Mental health clinicians (psychiatrists, psychologists, social workers and mental health nurses) with specialised training in both SCIT and befriending programs will facilitate programs. External, blinded clinicians (psychologist, mental health nurses) will complete assessments at designated time-points. Facilitators will use the SCIT manual to complete the program. The manual first summarizes the rationale and theoretical underpinnings of SCIT. Next, it distinguishes SCIT from other psychosocial treatments for psychosis. Following this, it provides an overview of the SCIT intervention, along with notes pertinent to its implementation. Then it concludes with a description of the links between the specific intervention activities and the underlying theoretical model.

Social cognition training (SCIT) is a non- invasive, manualised talking therapy with a purpose of improving social cognition and social functioning for individuals with schizophrenia. It is comprised of three phases (i.e. Introduction and Emotions, Figuring out Situations and Checking it Out) administered in a group format. Participants’ enrolled in this program will be given a workbook comprising of the above sections to complete. During this completion process they will role-plays, games and technology activities (e.g. watching DVDs) as guided by each section. They will also be asked to complete ‘out of session tasks’ where they will describe their mood and / or situations they become involved with to debrief at the next session. The session are divided into 2 parts with a short break in between to assist maintenance of concentration and to practice socialising within the group.

Face to face clinical assessments will be at baseline (week 0) and weeks 12 (end-point) and 24 (post end point) , Intermittent phone contact will occur in between face to face visits and at Week 6 to monitor participants' wellbeing and discuss any concerns the participant may raise. Participants’ will be given Coles / Myer gift vouchers for participating in the trial ($50 at baseline, $50 at end-point, $50 at follow-up) and when needed, transported to and from the clinic.
Intervention code [1] 295056 0
Treatment: Other
Intervention code [2] 295140 0
Behaviour
Comparator / control treatment
The study will include 128 individuals diagnosed with psychosis who will be randomised to either a befriending program (comparison group) or the SCIT program (intervention). Participants will attend weekly, 2 hour face-to-face group sessions (2 facilitators, 6-8 participants) for 12 weeks at an inner city community mental health clinic. This will be in addition to participants' normal routine care.

Mental health clinicians (psychiatrists, psychologists, social workers and mental health nurses) with specialised training in both SCIT and befriending programs will facilitate programs. External, blinded clinicians (psychologist, mental health nurses) will complete assessments at designated time-points.

Befriending therapy is designed to be used as a control interaction for clinical trials of psychotherapy. It entails a series of conversations with a client of clients that are similar to those with whom you have a social acquaintance with. Specifically, it involved an ongoing discussion of everyday topics and / or events in a friendly way without any problem solving or exploration of emotions and feelings. Participants’ in this program will complete also be given a workbook to complete however this workbook will not compromise of section leading towards an overall goal. Instead it will describe the group format for each session e.g. check-in, ice-breaker exercises, activity 1, break, activity 2 etc. Similar to the SCIT group, sessions are divided into 2 parts with a short break in between to assist maintenance of concentration.

Face to face clinical assessments will be at baseline (week 0) and weeks 12 (end-point) and 24 (post end point) , Intermittent phone contact will occur in between face to face visits and at Week 6 to monitor participants' wellbeing and discuss any concerns the participant may raise. Participants’ will be given Coles / Myer gift vouchers for participating in the trial ($50 at baseline, $50 at end-point, $50 at follow-up) and when needed, transported to and from the clinic.
Control group
Active

Outcomes
Primary outcome [1] 298708 0
Bell Lysacker Emotion Recognition Task (BLERT)
Timepoint [1] 298708 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [1] 325021 0
Social Skills Performance Assessment
Timepoint [1] 325021 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [2] 325022 0
Meta Cognition Questionnaire
Timepoint [2] 325022 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [3] 325023 0
Social Functioning Scale
Timepoint [3] 325023 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [4] 325024 0
Hinting Task
Timepoint [4] 325024 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [5] 325026 0
Internal, Personal and Situational Attributions Questionnaire
Timepoint [5] 325026 0
Baseline (week 0)
End point (week 12)
Post study (week 24)
Secondary outcome [6] 325027 0
CogState BRIEF Battery
Timepoint [6] 325027 0
Baseline - 0 Weeks

Eligibility
Key inclusion criteria
1. Aged between 18 and 65 years (inclusive).
2. Fulfil the DSM-IV criteria practice for broadly defined early psychosis, based on the Diagnostic Interview for Psychosis. This includes diagnoses such as schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified.
3. Have a premorbid functioning IQ of 71 or above
4. Have a social functioning scale - communication score below 105
5. Have an educational attainment of Grade 4 or above
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a premorbid functioning IQ of 70 or below
2. Have a social functioning scale - communication score above 106
3. Have an educational attainment of Grade 3 or below
4. Being unable to understand study demands and therefore not being able to consent appropriately.

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 concealment was completed by central randomisation, using a computer generated randomization table on a 1:1 basis (SCIT to BT).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out using a computergenerated randomization table on a 1:1 basis (SCIT to BT).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be analysed using SAS 9.4. We will compare demographic and clinical differences between the groups at baseline (Fisher exact test for nominal variables and Mann-Whitney test or independent sample t test for continuous variables). Efficacy will be assessed according to standard Intention to Treat (ITT) analytic procedures (i.e. for those who do not complete the 24 week study period, we will carry forward their last observation on the study outcomes). Mean changes in clinical assessment will be assessed using mixed-model repeated-measure (MMRM) methods with treatment, week, and treatment-week interaction as fixed effects and intercept as the only random effect; baseline value will be the covariant. The MMRM analyses will be performed using the SAS PROC Mixed procedure. P values will be based on 2-tailored tests with significance levels of 0.05.

Previous pilot studies using a modified emotional training protocol have yielded large effect sizes on emotion identification of 1.60 and .94 respectively. Based an expected 2.2-point difference between baseline to post-test, a change score standard deviation of 2.6, and a baseline-post-test correlation of .50, a sample of 56 participants has 80% power to reject the null hypothesis. We estimate a dropout rate of 15-20% (from treatment to 6-month follow-up) resulting in a final sample size of approximately 128 participants who complete the study. This estimate is based on the dropout rates from our outpatient pilot study, which had retention rate of 83%, as well as our experience with group RCT research.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293890 0
Government body
Name [1] 293890 0
Australian Centre for Health Services Innovation
Address [1] 293890 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave Kelvin Grove QLD 4059
Country [1] 293890 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, QLD, 4072
Country
Australia
Secondary sponsor category [1] 292717 0
None
Name [1] 292717 0
Address [1] 292717 0
Country [1] 292717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295310 0
Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)
Ethics committee address [1] 295310 0
HREC Office – Centres for Health Research Level 7 Translational Research Institute Building Princess Alexandra Hospital Ipswich Road Woolloongabba QLD 4102
Ethics committee country [1] 295310 0
Australia
Date submitted for ethics approval [1] 295310 0
01/03/2016
Approval date [1] 295310 0
17/03/2016
Ethics approval number [1] 295310 0
HREC/16/QPAH/98

Summary
Brief summary
The social cognition training (SCIT) is a groupbased therapy that has a goal of improving thinking skills about social situations for individuals with psychotic disorders. Two trained therapists deliver the group over 12 weekly sessions, with each session lasting approximately 2 hours. Participants will be able to attend one of the sites convenient to where they live. The therapy involves education about emotions and social interaction using games and technology such as watching DVD’s. Participants will be asked to attend a clinical assessment at three times points (beginning of the study, end of study and 3 months post study)that will take approximately 2 hours of their time. The clinical assessment will include tests of thinking and problem solving skills, and questions about how people think in social situations and skills in identifying emotions from photographs of people. At the completion of the entire study, a summary of the results will be sent out to participants informing them of the outcomes of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66722 0
Dr Frances Dark
Address 66722 0
Macgregor Community Mental Health
519 Kessels Rd, Macgregor, QLD, 4109
Country 66722 0
Australia
Phone 66722 0
+61731678333
Fax 66722 0
Email 66722 0
Frances.Dark@health.qld.gov.au
Contact person for public queries
Name 66723 0
Ms Andrea Baker
Address 66723 0
Level 3, Dawson House
The Park Centre for Mental Health
Corner Ellerton Drive and Wolston Park Road
Wacol Queensland 4076
Country 66723 0
Australia
Phone 66723 0
+61732718660
Fax 66723 0
Email 66723 0
andrea_baker@qcmhr.uq.edu.au
Contact person for scientific queries
Name 66724 0
Dr Frances Dark
Address 66724 0
Macgregor Community Mental Health
519 Kessels Rd, Macgregor, QLD. 4109
Country 66724 0
Australia
Phone 66724 0
+61731678333
Fax 66724 0
Email 66724 0
Frances.Dark@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent for this IPD sharing
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary