ANZCTR - Registration

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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]

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

delusions

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

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]

Behaviour

Intervention code [2]

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]

Delusional severity as assessed by mean Positive and Negative Syndrome Scale (PANSS) P1 item (Delusions).

Timepoint [1]