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Trial registered on ANZCTR


Registration number
ACTRN12610000387022
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
13/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Social Functioning in Schizophrenia through Social Cognitive Remediation
Scientific title
Social Cognitive Remediation for Schizophrenia to assess changes in social cognitive ability and symptoms following an individualised training program.
Secondary ID [1] 251755 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social cognitive deficits 257333 0
Schizophrenia 257358 0
Condition category
Condition code
Mental Health 257477 257477 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual tailored program performed in group
setting which aims to improve deficit functioning
in three areas of social cognition; Theory of
Mind, Attribution Style and Emotion Processing.

Participants complete both group based activities
and learning interspersed with individual
computer training based on the three social
cognitive constructs.

The intervention is run in small groups of 6
Participants per group by a provisional
psychologist. The program will be delivered
over 13 weeks and each of these 13 weekly
session is 1 hour in duration. The sessions
are comprised of a mixture of group activities
and computer based training tasks.

Computer based tasks: Training in 3 areas of
social cognition:

a) Theory of Mind
Computerised tasks which
require participants to consider the actions and
intentions of people in the format of video
vignettes of various social scenarios.

Written vignettes of social situations presented
whereby participant has to explain (by
choosing multiple choice answer) what the faux
pas is/ why someone said this.., etc.

Perspective taking task - False beliefs are presented
in written form and user must interpret situations
appropriately, e.g. If this happened...... then what
would A think about B (focusing on second-order
beliefs).

b) Emotion Recognition
Baron-Cohen 'Mind
reading-Interactive guide to
emotion' consists of facial expressions and
vocalisations in a story for 412
emotions (24 groups).

c) Attribution Style
Situations presented in form
of a statement and four interpretations to choose
from – then Decision made and/or plausibility rating
given for each interpretation. Further information is
then given and a second decision is made and/or a
change in plausibility ratings (i.e. if they want to change)

25 scenarios – in addition to an initial statement –
followed by two successive statements, each providing
additional information that further disambiguates
the scenario. Participant asked to change
decision/plausibility rating if desire.

Paintings presented (on computer in power-point
show) and four possible titles to choose from according
to plausibility.

Group Based Activities:

Emotion Processing-'' Learning how to observe
emotion''

a) Confusing Emotions- Each participant asked to
briefly dot point a time in their own lives when
they confused the emotion of someone else
(pen/paper). This will be introduced with a brief
antidote by clinician to illustrate (5mins)

b) Knowing Emotion- Each participant asked to
list as many emotions possible (pen/paper)
(5mins). These individual lists are then
combined to form a group list of emotions
(whiteboard) (5 mins)

c) Linking emotions to facial expressions- Group
uses knowledge from part b (knowing emotions)
to identify emotions in Elkman's Photo's
(slideshow/ group generated whiteboard list) (15
mins). Participants then pair up for a quiz which
requires them to identify the emotion depicted in
a series of other photos, cartoons, paintings
showing facial emotion (20 items) (20 mins)

Attribution Style- 'Social Investigators'

a) Causal Explanations- Group brainstorms list of
possible explanations for positive and negative
events (slide show) 10 items-5
positive/5negative) (15 mins).

B) Using facts (situation variables or statements)
rather than inferences to draw conclusions-
Illustrated with a game of '20 questions'
conducted in pairs. Each participant gets a
printed scenario of an ambiguous event and
partner must ask questions to obtain information
about the cause (answer also included on sheet)
(40 mins).

Theory of Mind- 'Recognising the beliefs of
other people'

a) Video-based training- Group views 10 scenes
(showing 2 or more people) from popular cinema
which requires identification of character mental
states. Each participants dot points a general
description of the scene (who involved/what
were they doing/what happened). Participants
must then dot point what the characters might
think/feel/want (can be further prompted with
questions: why do you think they did that?)
(pen/paper) (40 mins)

b) False Belief Picture sequence- Quiz which
requires participants to order short cartoon
sequence in order to tell a story (4 items per
sequence/4 sequences) presented on slideshow
(15 mins)
Intervention code [1] 256447 0
Rehabilitation
Intervention code [2] 256465 0
Treatment: Other
Comparator / control treatment
Treatment as usual- existing pharmacotherapy
regimens and weekly case manager meeting.
Researchers will not alter existing managment of
participants randomly assigned to the control
group. Consequently, both meetings and
pharmacotherapy are likely to vary according to
individual presentations, needs and
preferences/abilities of their case worker and
prescribing physicians. Researchers expect the
majority of the these individuals will be currently
taking some form of anti-psychotic medications.
Atypical Antipsychotics may include; risperidone,
olanzapine, quetiapine, clozapine, aripiprazole
and paliperidone. Typical antipsychotic
medications include the following classes;
chlorpromazine, thioridazine, trifluperazine,
haloperidol, flupenthixol and zuclopenthixol. It is
also possible that participants may be on other
classes of medications such as mood stabilisers.
Untill recruitment it is not possible to stipulate
this information. In regards to case managment,
determined by individual needs, these will be
structured around mental state, containment
around any presenting crisis, medication
concerns or other presenting problems. It will
not involve use of other psychological
interventions. Duration should be no longer that
1 hour (except in case of deterioration of mental
state).
Control group
Active

Outcomes
Primary outcome [1] 258388 0
Theory of Mind Ability- Will be assessed using
Steffan Moritz/ Robyn Langdon computerised
sequencing task. The cartoon version of this task
is a common neuropsychological measure of Theory of Mind (ToM) ability- Morritz and collegues in Germany are the
first to have computerised this measure to allow
for a more standardised tool which will promote
psychometric comparison.
Timepoint [1] 258388 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)
Primary outcome [2] 258389 0
Attribution Style- will be measured using the
Internal, Personal, Situational Attribution
Questionnaire( IPSAQ) (Kinderman & Bentall,
1996) - 32 social scenarios (16 positive
outcomes/16 negative outcomes) which require
respondent to write down most likely cause of
each. Answers are categorised as
internal/external and personal/situational locus.
Timepoint [2] 258389 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)
Primary outcome [3] 258390 0
Emotion Processing Ability a) Emotion
Recognition will be measured using the Diagnostic Analysis of Nonverbal Accuracy Scale (DANVA)
(Nowicki) - computerised exercise of
photographs depicting facial expression and
audio recordings of vocal tones which requires a
judgment about the emotion content of each (8
mins). Most commonly used in
neuropsychological research. Training using the
Baron-Cohen ' mind-reading' program will also
be used which trains individuals in recognising
emotions in facial expression and through vocal
prosody.
Timepoint [3] 258390 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)
Secondary outcome [1] 264128 0
Moderator variables Pharmacology, length of
illness and education as three moderator
variables will be assessed with a brief
demographic survey attached to the Participant
information and consent.
Timepoint [1] 264128 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)
Secondary outcome [2] 264185 0
Changes in symptoms
will be assessed at pre/post assessments using
the Symptom Checklist 90 (Derogatis, 1977)-
self report measure of psychological symptoms.
Timepoint [2] 264185 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)
Secondary outcome [3] 264186 0
To assess changes in social functioning ability,
the social functioning scale (birchwood) will be
administered at pre/post time points. ) Social
Functioning Scale: 79 item questionnaire (self
report or interview)- rates function and
frequency of daily social activities on 6
subscales; social engagement, interpersonal
communication, activities of daily living,
recreational activities and social activities.
Timepoint [3] 264186 0
13 weeks and 6 month follow-up are timed from
the point of pre assessment (following referral
and diagnostic interview)

Eligibility
Key inclusion criteria
Diagnosis of Schizophrenia, current pharmacotherapy treatment overseen by case manager.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Drug or alcohol concerns or undiagnosed psychiatric problem.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be existing clients of the Eastern Mental Health service and will be referred to the program
as part of on-going treatment. Clients will be drawn from the services in the Maroondah and Camberwell
Community Care Units (CCU's) as well as from the Mobile Support and Treatment (MST) teams at Maroondah and Box Hill Hospital sites.
The participants recruited from the Maroondah Sites will be allocated to the Treatment group and the participants from the Box Hill sites will be allocated to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256935 0
University
Name [1] 256935 0
Deakin University
Country [1] 256935 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Psychology
221 Burwood Highway
Burwood
Victoria 3125
Country
Australia
Secondary sponsor category [1] 256202 0
Other Collaborative groups
Name [1] 256202 0
Eastern Health
Address [1] 256202 0
Level 3 Building 5 Arnold Street
Box Hill
Victoria 3128
Country [1] 256202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258937 0
Eastern Health Research & Ethics
Ethics committee address [1] 258937 0
Level 3 Building 5 Arnold Street
Box Hill
Victoria 3128
Ethics committee country [1] 258937 0
Australia
Date submitted for ethics approval [1] 258937 0
Approval date [1] 258937 0
06/05/2010
Ethics approval number [1] 258937 0
E86/0910

Summary
Brief summary
This study aims to investigate the efficacy of a
social cognitive remediation program for adult
individuals with schizophrenia. The program is
tailored to individual ability discerned from
baseline assessment but conducted in a group
setting for increased peer support and
interaction. It is hypothesised that completion of
the program will result in improved social
cognitive ability in three primary domains. It is
also hypothesised that such improvements will
extend to social functioning in the community
and overall symptomatology.
Trial website
Trial related presentations / publications
Peer review at Deakin University
Public notes

Contacts
Principal investigator
Name 31141 0
Address 31141 0
Country 31141 0
Phone 31141 0
Fax 31141 0
Email 31141 0
Contact person for public queries
Name 14388 0
Jerome Caspersz
Address 14388 0
School of Psychology
Faculty of Health, Medicine, Nursing and Behavioural Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 14388 0
Australia
Phone 14388 0
+61 411 243 641
Fax 14388 0
Email 14388 0
jcas@deakin.edu.au
Contact person for scientific queries
Name 5316 0
Jerome Caspersz
Address 5316 0
School of Psychology
Faculty of Health, Medicine, Nursing and Behavioural Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 5316 0
Australia
Phone 5316 0
+61 411 243 641
Fax 5316 0
Email 5316 0
jcas@deakin.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

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