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Trial registered on ANZCTR


Registration number
ACTRN12616000976482
Ethics application status
Approved
Date submitted
18/07/2016
Date registered
25/07/2016
Date last updated
11/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of individualised metacognitive therapy (MCT+) for delusions in psychosis
Scientific title
Individualised metacognitive therapy (MCT+) for delusions: A randomized controlled
rater-blind study
Secondary ID [1] 289694 0
Nil known
Universal Trial Number (UTN)
U1111-1185-4422
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia spectrum disorders 299497 0
delusions 299498 0
Condition category
Condition code
Mental Health 299484 299484 0 0
Schizophrenia
Mental Health 299485 299485 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metacognitive therapy (MCT+) is a novel psychotherapeutic approach that builds on the concepts and goals of cognitive-behavioural therapy for psychosis. MCT+ targets the cognitive biases (i.e. distortions in the collection and processing of information) thought to underlie the formation and maintenance of delusional beliefs, and aims to bring to the attention of patients the cognitive dysfunctions that may be causing or maintaining their delusional symptoms (i.e. ‘metacognitive’ implies ‘thinking about one’s thinking’). One of the three fundamental components of the programme is knowledge translation. The second component is a demonstration of the negative consequences of these cognitive biases via exercises that target each bias individually. Finally, patients are offered alternative thinking strategies, which may help them to arrive at more appropriate inferences and thereby avoid the ‘cognitive traps’ that otherwise lead to delusional beliefs. It consists of 8 modules covering (i) six cognitive biases common in psychosis (jumping-to-conclusions, attribution bias, belief inflexibility, theory of mind deficits, false memories, depressive thinking styles), (ii) an introductory and relapse prevention module. It is individually administered (face-to-face) by a psychologist (eligible or working towards eligibility for clinical endorsement) across 4 x 2 hour sessions, once/week for 4 weeks (plus 3 assessment sessions at baseline, 6-week follow-up, 6-month follow-up) at Lyell McEwin, Flinders and Noarlunga Hospitals. Attendance to the four individual therapy sessions will be recorded for each participant.
Intervention code [1] 295316 0
Behaviour
Intervention code [2] 295367 0
Rehabilitation
Comparator / control treatment
The study will utilise a cognitive remediation active control group (i.e., the 'Cognitive Remediation in Psychiatry Program' developed by 'HAPPYneuron'), covering four cognitive domains (working memory, processing speed, verbal learning, reasoning and problem-solving); modules are accessed online and will be individually administered (face-to-face) by a psychologist (eligible or working towards eligibility for clinical endorsement) across 4 x 2 hour sessions, once/week for 4 weeks (plus 3 assessment sessions at baseline, 6-week follow-up, 6-month follow-up) at Lyell McEwin, Flinders and Noarlunga Hospitals.
Control group
Active

Outcomes
Primary outcome [1] 298963 0
Delusional severity as assessed by mean Positive and Negative Syndrome Scale (PANSS) P1 item (Delusions).
Timepoint [1] 298963 0
Baseline, 6-week follow-up (post commencement of intervention; T1), 6-month follow-up (post 6-week follow-up; T2)
Primary outcome [2] 298964 0
Delusional severity as assessed by mean Psychotic Symptom Rating Scales (PSYRATS) delusion subscale total score.
Timepoint [2] 298964 0
Baseline, 6-week follow-up (post commencement of intervention; T1), 6-month follow-up (post 6-week follow-up; T2)
Secondary outcome [1] 325771 0
Brief Assessment of Cognition in Schizophrenia (BACS) will be used to assess various cognitive domains (e.g., working memory, verbal learning, reasoning and problem-solving, processing speed).
Timepoint [1] 325771 0
Baseline, 6-week follow-up (post commencement of intervention; T1), 6-month follow-up (post 6-week follow-up; T2)
Secondary outcome [2] 325772 0
Clinical insight will be assessed with the Schedule for Assessment of Insight
Timepoint [2] 325772 0
Baseline, 6-week follow-up (post commencement of intervention; T1), 6-month follow-up (post 6-week follow-up; T2)
Secondary outcome [3] 325773 0
Cognitive insight will be assessed with the Beck Cognitive Insight Scale (i.e., measures of self-certainty and self-reflectiveness)
Timepoint [3] 325773 0
Baseline, 6-week follow-up (post commencement of intervention; T1), 6-month follow-up (post 6-week follow-up; T2)

Eligibility
Key inclusion criteria
a) Must have a DSM-5 diagnosis of a schizophrenia spectrum disorder (this will be confirmed by the ‘Psychotic Disorder’ subscale of the Mini-International Neuropsychiatric Interview or M.I.N.I).

b) Must hold mild to moderate delusional beliefs as a minimum; this will be confirmed by a baseline ‘Delusions’ subscale score >3 of the Positive and Negative Syndrome Scale (PANSS).

c) Must be able to speak, read and understand English and have the ability to respond to questions and follow instructions.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) primary diagnosis of substance use disorder
b) IQ<70
c) severe organic brain disorders

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)
Yes; treatment arm allocation was performed observer-blind and communicated to patients by a person who was not involved in baseline assessment (of primary PANSS measure) via a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A total of 30 participants per condition is sufficient to produce a power of .80 to detect a moderate-to-large between-within interaction effect in a two-group repeated-measures design (level of statistical significance: 5%; effect size: 0.5).

It is proposed that repeated-measures analysis-of-variance (RM-ANOVA) inferential statistics will be employed to test the hypotheses on the various measures between the MCT+ and cognitive remediation groups pre- and post-treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6186 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 6187 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 6188 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 13621 0
5042 - Bedford Park
Recruitment postcode(s) [2] 13620 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 13622 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 294079 0
University
Name [1] 294079 0
Flinders University
Address [1] 294079 0
GPO Box 2100, Adelaide 5001, South Australia
Country [1] 294079 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide 5001, South Australia
Country
Australia
Secondary sponsor category [1] 292951 0
None
Name [1] 292951 0
Address [1] 292951 0
Country [1] 292951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295493 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 295493 0
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 295493 0
Australia
Date submitted for ethics approval [1] 295493 0
22/04/2013
Approval date [1] 295493 0
11/07/2013
Ethics approval number [1] 295493 0
HREC/13/TQEHLMH/77

Summary
Brief summary
Delusions are characteristic of people with psychosis. Many of these people do not respond well to current drug treatments and require additional psychological treatment. This project is an investigation into the efficacy of psychological treatments for delusions in psychosis, focusing on a new therapy (MCT+) which combines cognitive-behavioural therapy for psychosis and metacognitive training. Cognitive Behavioural Therapy for psychosis develops an awareness of the implausible content of a patient’s delusion, while metacognitive training targets the problematic thinking styles underlying delusional beliefs. It is expected that MCT+ will be one of the most effective psychological treatments for reducing delusional symptoms.

The first aim of the proposed project is to determine the unique contribution of an individually-administered MCT+ program, combining the important facets of MCT and Cognitive Behavioural Therapy, over a standard cognitive remediation program (HAPPYneuron) targeting only neuropsychological cognitive deficits. The second aim is to determine the persistence of any improvements due to MCT+ by including a longitudinal follow-up. In sum, this project will provide the theory-driven evidence base that is needed to inform and influence clinicians to roll-out MCT+ to improve treatment for delusional people with psychosis.

Primary Hypothesis: Participants who receive metacognitive training (MCT+) will show a reduction in delusional severity whilst improving clinical and cognitive insight (relative to participants in the cognitive remediation control condition). Participants randomised to the cognitive remediation control condition will show improvements to the “cognitive symptoms” of psychosis, including improved language and memory skills (relative to participants in the metacognitive training condition).
Trial website
Trial related presentations / publications
Balzan, R. P., & Galletly, C. (2015). Metacognitive Therapy (MCT+) in patients with psychosis not receiving antipsychotic medication: A case study. Frontiers in Psychology, 6. doi:10.3389/fpsyg.2015.00967
Public notes

Contacts
Principal investigator
Name 67466 0
Dr Ryan Balzan
Address 67466 0
School of Psychology
Social Sciences North
GPO Box 2100
Adelaide, 5001, South Australia
Country 67466 0
Australia
Phone 67466 0
+61 8 82013082
Fax 67466 0
Email 67466 0
ryan.balzan@flinders.edu.au
Contact person for public queries
Name 67467 0
Dr Ryan Balzan
Address 67467 0
School of Psychology
Social Sciences North
GPO Box 2100
Adelaide, 5001, South Australia
Country 67467 0
Australia
Phone 67467 0
+61 8 82013082
Fax 67467 0
Email 67467 0
ryan.balzan@flinders.edu.au
Contact person for scientific queries
Name 67468 0
Dr Ryan Balzan
Address 67468 0
School of Psychology
Social Sciences North
GPO Box 2100
Adelaide, 5001, South Australia
Country 67468 0
Australia
Phone 67468 0
+61 8 82013082
Fax 67468 0
Email 67468 0
ryan.balzan@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary