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Trial registered on ANZCTR


Registration number
ACTRN12617001389392
Ethics application status
Approved
Date submitted
21/09/2017
Date registered
29/09/2017
Date last updated
29/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can individuals currently residing in a Queensland Health Community Care Unit (CCU), and diagnosed with a severe enduring mental illness (SEMI) improve their social functioning with the introduction of Social Cognition Interaction Training (SCIT)?
Scientific title
Can individuals currently residing in a Queensland Health Community Care Unit (CCU) and diagnosed with a severe enduring mental illness (SEMI) improve their social functioning with the introduction of Social Cognition Interaction Training (SCIT)
Secondary ID [1] 292972 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-5105
Trial acronym
SCIT trial at CCU, SCHHS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
social cognition 304892 0
Serious Enduring Mental illness 304895 0
Condition category
Condition code
Mental Health 304139 304139 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-drug trial
Procedures - The trial will follow the Social Cognition Interaction Training (SCIT) manual developed by Robert, Penn & Combs 2016. This is a group psychotherapy model. Survey measures utilised to indicate improvement in social cognition are the Social Functioning Scale (Birchwood et al, 1990), the BLERT (Bell Lysaker Emotional Recognition Task (Bell, M Bryson, G & Lysaker, P 1997), the Hinting Task (Corcoran, Mercer & Frith 1995) and the Social Cognition Screening Questionnaire (SCSQ, V6.) designed by Roberts (2014). These measures will be undertaken in a pre, post and followup repeat design method.

The trial will be carried out by the lead researcher and co facilitator (Clinical psychologist) employed at the CCU. The lead researcher has over 18 years experience working in the area of mental health for Queensland Health.

Procedures - the model addresses emotional recognition. attributional bias and social behaviour.

Delivery - will be face to face with participants

Duration- the trial will be for 2 hrs once per week with a half break and last for 10 weeks.

Location - the trial will be taking place at the CCU.

Intervention code [1] 299183 0
Rehabilitation
Comparator / control treatment
Residents at the CCU will be approached to consider volunteering in the clinical trial. Individuals wishing participate in the 10 week SCIT trial will be identified as Group 1. Residents who do not want to do the 10 week trial but prepared to complete surveys will be known as Group 2 (Comparison Group). Residents wanting no part in the trial continue as per their rehabilitation program.

Control group
Active

Outcomes
Primary outcome [1] 303455 0
One measure is The Social Functioning Scale (SFS) (Birchwood et al. 1990) which has 2 parts, Part 1. records subjective answers to 18 questions in relation to Withdrawal / social engagement, interpersonal communication, independence performance, independent competence, recreation, social activities and employment/occupation. The total scores for each section is recorded as a raw score. Raw scores totaled provide an overall social functioning score but can also be scaled to identify problem or areas of difficulty.

Timepoint [1] 303455 0
This clinical research trial is using a repeat measure design. The SFS will be undertaken by participants at the pre, post and followup periods. A baseline measure before the commencement of SCIT trial will be identified, The post measure after the 10 weeks SCIT trial will provide results that may suggest improvement in social functioning and the 3-month follow-up will provide results as to whether any improvement in social functioning has been maintained over time.
Primary outcome [2] 303513 0
The 2nd measure to determine if social functioning behaviour of a person living with schizophrenia can be improved is by using the Bell-Lysaker Emotion Recognition Task (BLERT; Bell, Bryson, & Lysaker, 1997). This measures the ability to correctly identify 7 emotional states (happiness, sadness, fear, disgust, surprise, anger or no emotion). The BLERT assists individuals’ underlying visual perception to cognitively link to emotions as a method to improve social outcomes. Participants view 21, 10-second video clips of a male actor, providing dynamic facial, vocal, tonal, and upper body movement cues. Scoring is in a range from 0-21. The scoring identifies the individual's ability to correctly select positive or negative emotions in others.
Timepoint [2] 303513 0
This clinical research trial is using a repeat measure design. The BLERT will be undertaken by participants at the pre, post and followup periods. A baseline measure before the commencement of SCIT trial will be identified, The post measure after the 10 weeks SCIT trial will provide results that may suggest improvement in social functioning and the 3-month follow-up will provide results as to whether any improvement in emotional recognition has been maintained over time which can benefit social functioning behaviour.
Primary outcome [3] 303514 0
The 3rd measure to determine if social functioning behaviour of a person living with schizophrenia can be improved is the Hinting Task (Corcoran, Mercer & Frith 1995). this measure examines the ability of an individual to infer the true intent behind indirect speech which may be ambiguous or confusing. Individuals are read 10 ten short stories involving two people. Each story ends with one of the characters saying something. Scoring total is 20. 2 points for a correct interpretation of the first question. If the person gives no response, additional prompt and question score = 1 point for the correct answer. If the individual does not respond score = 0. The mean scores are are simply compared between testing times, however higher scores using a basic correlation analyses typically have higher functioning scores.
Timepoint [3] 303514 0
This clinical research trial is using a repeat measure design. The Hinting Task will be undertaken by participants at the pre, post and followup periods. A baseline measure before the commencement of SCIT trial will be identified, The post measure after the 10 weeks SCIT trial will provide results that may suggest improvement in social functioning and the 3-month follow-up will provide results as to whether any improvement in understanding indirect speech has been maintained over time which can benefit social functioning outcomes.
Secondary outcome [1] 339065 0
The secondary outcome of using the SFS is that staff also complete the same 18 questions as the individual and provides an objective raw score to all areas. Comparing the two measures will provide a moderating indicator of subjective rating and independent view of difficult or problem areas.
Timepoint [1] 339065 0
This clinical research trial is using a repeat measure design. The SFS will be undertaken by participants at the pre, post and followup periods. A baseline measure before the commencement of SCIT trial will be identified, The post measure after the 10 weeks SCIT trial will provide results that may suggest improvement in social functioning and the 3-month follow-up will provide results as to whether any improvement in social functioning has been maintained over time.
Secondary outcome [2] 339157 0
The 4th measure to determine if social functioning behaviour of a person living with schizophrenia can be improved is the Social Cognition Screening Questionnaire (SCSQ, V6.) designed by Roberts (2014). It is a measure developed specifically for SCIT. It simultaneously measures ToM, Schematic Inference, verbal memory scales, metacognitive overconfidence as well as providing a hostility score that suggests attributional bias. It involves reading the participant 10 short Vignettes one by one, with three Yes / No answers (A, B, C) followed by a confidence question (D). The 5 areas of performance are scored from 0- 29 with a normative mean and standard deviation. Scores of 6 or lower in each area suggests clinically significant impairment.
Timepoint [2] 339157 0
This clinical research trial is using a repeat measure design. The SCSQ will be undertaken by participants at the pre, post and followup periods. A baseline measure before the commencement of SCIT trial will be identified, The post measure after the 10 weeks SCIT trial will provide results that may suggest improvement in social cognition and the 3-month follow-up will provide results as to whether any improvement in social cognition has been maintained over time.

Eligibility
Key inclusion criteria
All residents of the psychiatric rehabilitation unit will be eligible to self-select for participation in one of two groups for the clinical research trial. Final decision will be made by treating psychiatrist of the unit
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
IQ below 65,
Current ongoing substance misuse,
Psychiatrically unwell. This situation will be determined by the consultant psychiatrist with regards to an individuals ability to engage and mental health stability at the time of the trial commencement.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
As recovery is a concept of mental health intervention, the goal is to develop partnerships in treatment that strive to empower, direct and achieve the individuals identified recovery whatever that may be.

This trial is open, so residents know what the research is about and they have the ability to self-select and volunteer into 1 of 2 groups or choose not to participate at all. The idea is that if people know what the research is about it may increase participation rates for a group which historically has low participation rates. the benfits will be
1. Maximising sample size (and hence power).
2. Greater ethical respect for autonomy
3. Greater adherence to protocol
4. Greater ecological validity.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data analysis of the clinical trial research surveys will involve a Repeated Measures Design ANOVA, utilising the SPSS statistical program.

The total available sample size is limited, at approximately 35 meaning power calculations are difficult. Assuming an independent t-test with a significance level of 0.05 and power of 0.80, to detect a 15% point change on a measure of social cognition between control and intervention groups, with a standard deviation of 10, a minimum of 8 participants are required in each group. Allowing for an estimated 30% drop-out this suggests a minimum of 12 participants in each group (24 in total) are needed to complete the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/11/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297572 0
University
Name [1] 297572 0
University of the Sunshine Coast (USC)
Country [1] 297572 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
USC, Locked Bag 4
Faculty of Arts, Business & Law,
University of the Sunshine Coast,
Maroochydore DC, Queensland, 4558, Australia
Country
Australia
Secondary sponsor category [1] 296587 0
Hospital
Name [1] 296587 0
Sunshine Coast Hospital and Health Service
Address [1] 296587 0
Janelle Killick, Community Care Unit
6 lady Musgrave Drive,
Mt Creek Qld 4457
Country [1] 296587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298666 0
The Prince Charles Hospital HRES, Qld
Ethics committee address [1] 298666 0
Ethics committee country [1] 298666 0
Australia
Date submitted for ethics approval [1] 298666 0
11/05/2017
Approval date [1] 298666 0
07/09/2017
Ethics approval number [1] 298666 0
HREC/17/QPCH/162

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2075 2075 0 0
/AnzctrAttachments/373692-HREC 17-162 NEAF final approval 7.9.17.pdf (Ethics approval)

Contacts
Principal investigator
Name 77826 0
Mr Michael Bradburn
Address 77826 0
USC, Locked Bag 4
Faculty of Arts, Business & Law,
University of the Sunshine Coast,
Maroochydore DC, Queensland, 4558, Australia
Country 77826 0
Australia
Phone 77826 0
+61424960557
Fax 77826 0
Email 77826 0
[email protected]
Contact person for public queries
Name 77827 0
Michael Bradburn
Address 77827 0
USC, Locked Bag 4
Faculty of Arts, Business & Law,
University of the Sunshine Coast,
Maroochydore DC, Queensland, 4558, Australia
Country 77827 0
Australia
Phone 77827 0
+61424960557
Fax 77827 0
Email 77827 0
[email protected]
Contact person for scientific queries
Name 77828 0
Michael Bradburn
Address 77828 0
USC, Locked Bag 4
Faculty of Arts, Business & Law,
University of the Sunshine Coast,
Maroochydore DC, Queensland, 4558, Australia
Country 77828 0
Australia
Phone 77828 0
+61424960557
Fax 77828 0
Email 77828 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

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