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Trial registered on ANZCTR


Registration number
ACTRN12613001126707
Ethics application status
Not yet submitted
Date submitted
3/10/2013
Date registered
9/10/2013
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of a Psychological Intervention for Delusions on Reducing Aggression in Schizophrenia Patients in a Forensic Psychiatric Setting
Scientific title
The Effects of a Psychological Intervention for Delusions on Reducing Aggression in Schizophrenia Patients in a Forensic Psychiatric Setting
Secondary ID [1] 283319 0
None
Universal Trial Number (UTN)
U1111-1148-5551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 290207 0
Condition category
Condition code
Mental Health 290600 290600 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Metacognitive Training Program for Psychosis (MCT) is a cost free download (http://www.uke.de). The MCT is designed to assist people in changing their thinking patterns that contribute to delusions, which subsequently avoids relapse or reduces the impact of delusions. Each module begins with psychoeducational elements and “normalising “through examples and exercises. Pathological extremes for each cognitive bias are then highlighted and their implications for daily life discussed with case examples of people with psychosis. Dysfunctional coping strategies such as avoidance are also highlighted. The sessions are interactive and entertaining and aim to capture participants’ attention, with a move away from the drill and practice approaches often incorporated with traditional Cognitive Behaviour Therapy group programs. Participants are also required to complete homework between sessions. Module Four of the MCT program contains a brief section on emotion perception, which will be enhanced further with Emotion Recognition Training (ERT) (Marsh et al., 2013). The aim is to enhance the effects of Module Four’s brief section on emotion perception, which sensitises participants to the ambivalence of social situations. This MCT program will be incorporated in a forensic psychiatric setting and for clarity will be called the Metacognitive Training for Psychosis – Forensic (MCT-F), which is endorsed by Professor Steffen Moritz. The MCT-F program will run for six weeks, twice a week for one hour per session. No more than 10 participants will be recruited into each group.
Intervention code [1] 288038 0
Rehabilitation
Intervention code [2] 288039 0
Behaviour
Intervention code [3] 288102 0
Treatment: Other
Comparator / control treatment
The Waitlist Control Group are recruited from the same State Forensic Mental Health Service (SFMHS) and tested at the same time at the start of each cohort to be run through the MCT-F program. They will be offered treatment after the first cohorts have completed the post-treatment (T2) testing.
Control group
Active

Outcomes
Primary outcome [1] 290613 0
First Aim: To test the effects of a psychological intervention for delusions on reducing aggression in patients with schizophrenia and no comorbid brain injury in a forensic psychiatric setting.

Hypothesis 1: Aggression will be reduced in patients receiving MCT-F compared to a wait-list control group.

Outcome measure: Dynamic Appraisal of Situational Aggression (DASA) (Ogloff & Daffern, 2006)
Timepoint [1] 290613 0
Baseline and immediately post-treatment
Primary outcome [2] 290614 0
Hypothesis 2: MCT-F will reduce delusional severity and improve social functioning, and cognitive biases and deficits known to be associated with delusions and targeted by MCT-F.

Outcomes measures:
1) Delusional severity indexed by a single score from the Psychotic Symptom Rating Scales (PSYRATS) Delusional Subscale (Haddock, McCarron, Tarrier, & Faragher, 1999)
2) Jumping to conclusions bias assessed using the “beads task” (see, e.g., (Phillips & Edwards, 1966; Langdon, Ward & Coltheart, 2010)
3) Attributional blaming bias indexed by a single score derived from the Ambiguous Intention Hostility Questionnaire (AIHQ) (Combs, Penn, Wicher, & Waldheter, 2007)
4) A composite measure of social-cognitive functioning derived from a test of emotion recognition (The Awareness of Social Interference Test – Revised (TASIT-R) Part One:) (McDonald, Flanagan, & Rollins, 2011) and a non-verbal (i.e. picture sequencing: Langdon & Coltheart, 1999) and verbal (i.e. story comprehension) test of theory of mind (see, e.g., Langdon, Ward & Coltheart, 2010)
5) Quality of life indexed by the total score from the WHOQOL-BREF (WHOQOL Group, 1998)
6) Readiness for treatment indexed by the Corrections Victoria Treatment Readiness Questionnaire (CVTRQ) (Casey, Howells, & Ward, 2007)
Timepoint [2] 290614 0
Baseline, immediately post training and at 2-month follow-up
Secondary outcome [1] 304907 0
Second Aim: To identify the best predictors of: 1) aggression at baseline; and 2) change in aggression following treatment.

Hypothesis 3: Lower IQ, worse cognitive and social-cognitive (i.e. emotion recognition and theory of mind) functioning, more severe psychotic symptoms, and comorbid psychopathic traits will predict higher levels of aggressions at baseline.

Potential predictors will include:
1) IQ indexed by the National Adult Reading Test (NART) (NART–R; Nelson 1982)
2) General neurocognitive capacity indexed by a single composite score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS Update) (Randolph, 2012)
3) General symptom severity indexed by a global score from the Scales for the Assessment of Positive and Negative Symptoms of Schizophrenia (SAPS and SANS) (Andreasen, 1984)
4) Psychopathic traits indexed by the Self-Report Psychopathy Scale – Short Form (SRP-SF) (Paulhus, Hempill, & Hare, in press)
5) Social-cognitive functioning score indexed by a single score derived from the baseline measures of emotion recognition and theory of mind (McDonald, et al., 2011; Langdon & Coltheart, 1999; Langdon, et al., 2010)
6) Readiness for treatment indexed by Corrections Victoria Treatment Readiness Questionnaire (CVTRQ) ) (Casey, Howells, & Ward, 2007)
7) Engagement in the program indexed by the Intrinsic Motivational Inventory for Schizophrenia Research (IMI-SR) (Choi & Medalia, 2010)
Timepoint [1] 304907 0
Baseline and immediately post-treatment
Secondary outcome [2] 304908 0
Hypothesis 4: Higher IQ, better cognitive and social-cognitive functioning, greater readiness for treatment and more involvement in the program will predict better response to treatment.

Outcome measures will be baseline levels of aggression and pre- to post-treatment change in aggression.

Potential predictors will include:
1) IQ indexed by the National Adult Reading Test (NART) (NART–R; Nelson 1982)
2) General neurocognitive capacity indexed by a single composite score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS Update) (Randolph, 2012)
3) General symptom severity indexed by a global score from the Scales for the Assessment of Positive and Negative Symptoms of Schizophrenia (SAPS and SANS) (Andreasen, 1984)
4) Psychopathic traits indexed by the Self-Report Psychopathy Scale – Short Form (SRP-SF) (Paulhus, Hempill, & Hare, in press)
5) Social-cognitive functioning score indexed by a single score derived from the baseline measures of emotion recognition and theory of mind (McDonald, et al., 2011; Langdon & Coltheart, 1999; Langdon, et al., 2010)
6) Readiness for treatment indexed by Corrections Victoria Treatment Readiness Questionnaire (CVTRQ) ) (Casey, Howells, & Ward, 2007)
7) Engagement in the program indexed by the Intrinsic Motivational Inventory for Schizophrenia Research (IMI-SR) (Choi & Medalia, 2010)
Timepoint [2] 304908 0
Baseline and immediately post-treatment

Eligibility
Key inclusion criteria
Inclusion criteria is a DSM-IV-TR (American Psychiatric Association, 2000) of schizophrenia or schizoaffective disorder, be aged between 18-55 years, have English as a first language (or educated from primary school age in English) and have a history of aggressive behaviour.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include current alcohol/drug abuse, a comorbid acquired or developmental brain disorder, as assessed by the treating Psychiatrist, or documented head trauma (unconscious for more than one hour).

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)
Informed consent will be obtained from each participant after they read an Information Sheet, followed by recording of demographic information and pre-treatment (T1) testing. Basic and clinical demographic information such as age, gender, educational background and marital status, and medication will be recorded at baseline. The DASA primary outcome measure is completed as part of service delivery by nursing staff on a 24 hour basis.

Participants will be randomly allocated to either a treatment group (MCT-F) or waitlist control group. This will be through allocation concealment by way of sealed opaque envelopes. Participants assigned to the MCT-F treatment group will then undergo six weeks of training while the wait-list group continues with their usual treatment on the ward. This is followed by a post-assessment immediately following the MCT-F group. The wait-list group will then be offered the program.

The study aims to recruit 48 participants in total from the State Forensic Mental Health Service, Western Australia. If further participants are required as a result of insufficient sample size, then these participants will be obtained from additional sites at Concord and Westmead hospitals, New South Wales, through Site Specific Ethics’ applications. A total of 24 participants from the MCT-F treatment group will be compared with 24 participants from the wait-list group. Participants will have a diagnosis of schizophrenia or schizoaffective disorder and will be referred from clinicians at the SFMHS.

Treatment will be run in groups of six to ten participants. For each treatment round, the pre-treatment assessment will take approximately two hours per participant with data for an entire cohort collected over two to three weeks. The MCT-F treatment group will then be conducted for six weeks. Following treatment, another two to three weeks would be required to collect the post-treatment data. Then, participants would need to be recruited and tested for the next round of six to ten participants. Participants will be reimbursed for the time spent in the testing sessions of $15 for pre-assessment and $15 for post-assessment in line with Macquarie University’s reimbursement of participants’ policy. This is not seen as an inducement as it is not part of service practice and is for the testing sessions only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like drawing a ticket out of an envelope.
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
Data analysis will be performed using the Statistical Package for Social Sciences (SPSS) for Windows, Version 20. Power analyses were performed using GPower 3.1.7.

First aim: ANCOVA is recommended to test the first aim, with the pretest scores as the covariate, the posttest scores as the dependent variable, and the two groups (MCT-F treatment group and the waitlist control group) as the independent variable. Since no previous studies have examined the effects of MCT-F on the primary outcome measure of aggression, a power calculation is based on previous studies of the effects of similar treatment studies on the secondary outcome measures of delusional severity and social cognition. For example, a previous study testing the efficacy of MCT with a sample size of 36 schizophrenia patients reported a moderate-large effect size of d equals .68 for the intensity of delusional distress (Moritz et al., 2011), while Kurtz and Richardson’s (2011) meta-analysis found a moderate effect size for improved theory of mind after social-cognitive training (d equals .46) across 19 treatment studies. Therefore, assuming a moderate effect size of d equals 0.45, a sample of N equals 48 will give power of 0.8 at a significance level of a equals .05 to test the first aim.

Second aim: Assuming a moderate effect size of d equals 0.45, a power analysis for seven predictor variables using linear multiple regression indicates that, to achieve a power of 0.8, with a significance level of a equals .05, the minimum sample size should be N equals 40 participants. Hence, it is suggested that the proposed sample of 48 is adequate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288052 0
University
Name [1] 288052 0
Department of Cognitive Science
Macquarie University
Country [1] 288052 0
Australia
Funding source category [2] 288053 0
Self funded/Unfunded
Name [2] 288053 0
Naomi Oliver
Clinical and Forensic Psychologist
Country [2] 288053 0
Australia
Funding source category [3] 288817 0
Charities/Societies/Foundations
Name [3] 288817 0
Schizophrenia Research Institute
Country [3] 288817 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Cognitive Science
Australian Hearing Hub
16 University Avenue
Macquarie University NSW 2109
Country
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289978 0
North Metropolitan Area Mental Health Services Human Research Ethics Committee (EC00273)
Ethics committee address [1] 289978 0
Ethics committee country [1] 289978 0
Australia
Date submitted for ethics approval [1] 289978 0
12/02/2014
Approval date [1] 289978 0
Ethics approval number [1] 289978 0
Ethics committee name [2] 289979 0
Macquarie University Ethics Review Committee (Human Research) (EC00124)
Ethics committee address [2] 289979 0
Ethics committee country [2] 289979 0
Australia
Date submitted for ethics approval [2] 289979 0
10/03/2014
Approval date [2] 289979 0
Ethics approval number [2] 289979 0

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

Contacts
Principal investigator
Name 43338 0
Miss Naomi Oliver
Address 43338 0
Macquarie University
Department of Cognitive Science
C/O
PO BOX 151
FLOREAT FORUM
FLOREAT WA 6014
Country 43338 0
Australia
Phone 43338 0
+61 (0) 429500042
Fax 43338 0
Email 43338 0
naomi.oliver@students.mq.edu.au
Contact person for public queries
Name 43339 0
Naomi Oliver
Address 43339 0
Macquarie University
Department of Cognitive Science
C/O
PO BOX 151
FLOREAT FORUM
FLOREAT WA 6014
Country 43339 0
Australia
Phone 43339 0
+61 (0) 429500042
Fax 43339 0
Email 43339 0
naomi.oliver@students.mq.edu.au
Contact person for scientific queries
Name 43340 0
Naomi Oliver
Address 43340 0
Macquarie University
Department of Cognitive Science
C/O
PO BOX 151
FLOREAT FORUM
FLOREAT WA 6014
Country 43340 0
Australia
Phone 43340 0
+61 (0) 429500042
Fax 43340 0
Email 43340 0
naomi.oliver@students.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

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