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Trial registered on ANZCTR


Registration number
ACTRN12613000978763
Ethics application status
Approved
Date submitted
30/08/2013
Date registered
3/09/2013
Date last updated
3/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving social thinking and social functioning in schizophrenia
Scientific title
The Development of a novel social cognitive training (SoCog) to improve social cognition and social functioning in Schizophrenia
Secondary ID [1] 283114 0
None
Universal Trial Number (UTN)
U1111-1147-3982
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social cognitive impairments in schizophrenia 289963 0
Condition category
Condition code
Mental Health 290333 290333 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we sought to compare the independent effects of two programs to improve social cognition in schizophrenia: “SoCog” Mental-State Reasoning Training (MSRT) and “SoCog” Emotion Recognition Training (ERT). Both SoCog programs consist of 12 one-hour sessions over 6 weeks . Training is run by two facilitators in small groups of 3-6 participants using a manual-driven suite of activities including games developed by us [e.g., Social Trivia (MSRT) and Face Detective (ERT)] and Tropfest Videos (http://tropfest.com/au/). The training approach of SoCog provides repeated exposure and practice of the skills that underlie complex mental-state reasoning abilities or emotion recognition abilities.

A weekly points system with prizes is used to provide extrinsic motivation. So, when a participant wins a game or they contribute a valid hypothesis or observation they can be awarded points at the discretion of the facilitator. Points are tallied and a prize (e.g., small toiletries and stationery items) is awarded to the participant with the most points at the end of each week. Likewise, intrinsic motivation plays an important role in overcoming the core motivational impairments in schizophrenia. With the latter in mind, we structured SoCog sessions to give a sense of control over training and to enhance engagement with the treatment; thus, facilitators set the activity for the first 20 minutes of a session and then participants chose an activity for the second 20 minutes with a 10-minute break between the first and second activity.

The specific training approach of SoCog-MSRT is that participants receive repeated exposure and practice of the skills that underlie complex mental-state reasoning abilities (e.g., interpreting and predicting other people’s actions/behaviours in terms of causal mental states; e.g., “Fred will do ‘x’ since he wants ‘y’ and believes ‘z’ about the situation”). Thus, activities centre on vignettes of social situations with a focus on making inferences and predictions about characters’ thoughts, feelings, and behaviours. Similar vignettes are repeated across different activities with frequent repetition of training materials and concepts and a focus on making inferences and predictions about characters’ thoughts, feelings, and behaviours. The facilitators’ roles are to guide discussion, and to explore a range of possible hypotheses for beliefs, perceptions, or behaviors that will involve the group in developing a reasonable explanation for a particular situation. This further allows for different possible interpretations and inferences from all group members, which presents an invaluable learning experience about the often ambiguous social interaction in the real world.

In contrast, SoCog-ERT is focussed on drawing attention to salient facial features that are important for accurate recognition of others’ emotions`. As with SoCog-MSRT this program relies on a suite of manualised games and activities developed specifically to direct attention to relevant facial features of commonly confused emotional expressions (e.g. using the eyebrows to distinguish fear from surprise).

Adherence to treatment was monitered via sign-off sheets which each participant was expected to sign before starting each group session. To encourage attendance 100% attendance certificates were awarded at a graduation ceromony at the completion of treatment. Completion certificates were also awarded.
Intervention code [1] 287836 0
Rehabilitation
Intervention code [2] 287847 0
Treatment: Other
Comparator / control treatment
Treatment as usual with no social cognitive intervention. Treatment as usual is defined as the treatment the participant is receiving from their current treatment team (inpatients and outpatients) and includes medication and any other rehabilitation programs (e.g., vocational) or day programs for inpatients. Our treatment groups also continued to receive treatment as usual with the addition of either ERT or MSRT.
Control group
Active

Outcomes
Primary outcome [1] 290369 0
Improved scores on the following measures of social cognitive and social functioning abilities:

1.Basic facial emotion recognition assessed using video clips of real-life vignettes of social interactions from the Emotion Evaluation Task component of The Awareness of Social Inference Test.
Timepoint [1] 290369 0
Immediate post-training and then again at 3-month follow-up
Primary outcome [2] 290382 0
2. The Reading the Mind in the Eyes Test .
Timepoint [2] 290382 0
immediate post-training and 3-month follow-up
Primary outcome [3] 290383 0
3. The Picture Sequencing Task is a classic measure of non-verbal ToM and, specifically, the ability to accurately sort false-belief story sequences to tell a story about a cartoon character who has acted on a false-belief .
Timepoint [3] 290383 0
immediate post-training and 3-month follow-up
Secondary outcome [1] 304367 0
Basic social skills including the tendency to make eye contact, maintain appropriate social distance, and to initiate and maintain conversation using the Social Skills Checklist developed by Bellack and colleagues (2004).
Timepoint [1] 304367 0
immediate post-training and 3-month follow-up
Secondary outcome [2] 304385 0
The short form of the Empathy Quotient which is a self-report measure of changes in cognitive empathy (understanding of another’s mental states), social skills (intuitive understanding of social situations), and emotional reactivity (ability to identify one’s own emotional response to others’ feelings).
Timepoint [2] 304385 0
immediate post-training and 3-month follow-up

Eligibility
Key inclusion criteria
A diagnosis of schizophrenia or schizoaffective disorder.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Learning difficulties; bipolar disorder or comorbid neurological illness; history of head injury (unconscious > one hour); current substance/alcohol abuse; and electroconvulsive therapy within the past six months.

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)
Participants are referred by clinicians and only then approached by researchers.

Because referrals were slow we could only partially randomise the first four cohorts of the study into either treatment (11) or a control group (10) to produce workable group sizes. These were drawn using an opaque envelope.

For the remainder of the trial Allocation wass not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using blocks of 3 and 6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial power analyses were calculated based on similar studies: one of which produced a large effect size (d = 1.24); and the other of which reported moderate effect sizes (eta squared = .37 to .44). To obtain a moderate effect size for 3 treatment groups such as in our study with an alpha level of .05 requires n = 52/group (total = 156), or, for a large effect, n = 21/group (total = 63). Based on these calculations,w e planned to recruit 40 into each treatment group and 48 into the TAU group (total = 128) which will allow us to detect significant differences with an alpha level of .05 and a power estimate of .80 if effect sizes are medium to large.

Planned mixed-between GLM analyses were performed initially but significant interactions between treatment groups (SoCog-ERT, SoCog-MSRT, and controls) and time were not found. This was likely due to the small sample sizes resulting in insufficient power. Observed power estimates for the interactions ranged from 6.6% - 37.2%.
Inspection of the data showed a general pattern of participants in the training groups have better scores than controls on several measures. As such, post-hoc repeated measures analyses were performed separately for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2009
Actual
16/09/2009
Date of last participant enrolment
Anticipated
29/08/2012
Actual
8/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1463 0
Cumberland Hospital - Westmead
Recruitment postcode(s) [1] 7298 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 287867 0
Charities/Societies/Foundations
Name [1] 287867 0
Australian Rotary Health Grant
Country [1] 287867 0
Australia
Funding source category [2] 287868 0
Charities/Societies/Foundations
Name [2] 287868 0
Schizophrenia Fellowship of New South Wales
Country [2] 287868 0
Australia
Funding source category [3] 287869 0
University
Name [3] 287869 0
Macquarie University
Country [3] 287869 0
Australia
Primary sponsor type
Individual
Name
Pamela Marsh
Address
Macquarie University
Sydney NSW 2109
Country
Australia
Secondary sponsor category [1] 286596 0
None
Name [1] 286596 0
Address [1] 286596 0
Country [1] 286596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289811 0
Western Sydney Local Health District
Ethics committee address [1] 289811 0
Ethics committee country [1] 289811 0
Australia
Date submitted for ethics approval [1] 289811 0
02/02/2009
Approval date [1] 289811 0
16/06/2009
Ethics approval number [1] 289811 0
HREC/09/WMEAD/38

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42550 0
Dr Pamela Marsh
Address 42550 0
ARC Centre of Excellence in Cognition and its Disorders
Level 3, Australian Hearing Hub
16 University Avenue
Macquarie University NSW 2109
Country 42550 0
Australia
Phone 42550 0
+61 02 9850 6769
Fax 42550 0
Email 42550 0
pamela.marsh@mq.edu.au
Contact person for public queries
Name 42551 0
Pamela Marsh
Address 42551 0
ARC Centre of Excellence in Cognition and its Disorders
Level 3, Australian Hearing Hub
16 University Avenue
Macquarie University NSW 2109
Country 42551 0
Australia
Phone 42551 0
+61 02 9850 6769
Fax 42551 0
Email 42551 0
pamela.marsh@mq.edu.au
Contact person for scientific queries
Name 42552 0
Pamela Marsh
Address 42552 0
ARC Centre of Excellence in Cognition and its Disorders
Level 3, Australian Hearing Hub
16 University Avenue
Macquarie University NSW 2109
Country 42552 0
Australia
Phone 42552 0
+61 02 9850 6769
Fax 42552 0
Email 42552 0
pamela.marsh@mq.edu.au

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
EmbaseA quasi-randomized feasibility pilot study of specific treatments to improve emotion recognition and mental-state reasoning impairments in schizophrenia.2016https://dx.doi.org/10.1186/s12888-016-1064-6
N.B. These documents automatically identified may not have been verified by the study sponsor.