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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Social cognitive deficits

Schizophrenia

Condition category

Condition code

Mental Health

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]

Rehabilitation

Intervention code [2]

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]

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]