Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000467033
Ethics application status
Approved
Date submitted
6/06/2010
Date registered
9/06/2010
Date last updated
9/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metacognition and Mindfulness: A Group Intervention for Reducing Distress in Early Episode Psychosis
Scientific title
Metacognition and Mindfulness: A Group Intervention for Reducing Distress in Early Episode Psychosis
Secondary ID [1] 251961 0
NA
Universal Trial Number (UTN)
U1111-1115-4559
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 257527 0
Condition category
Condition code
Mental Health 257687 257687 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: other
- 8 x 2 hour weekly sessions
- Total 8 week program
- Administered by 2 Clinical Psychology Trainee's and a Clinical Psychologist to groups of up to 10 people
- Each week begins with a 45 minutes delivered content on Metacognition. A different topic, such as attribution, thinking errors affecting self esteem, or jumping to conclusions is delievered each week. The topic is delievered via powerpoint and active discussion is encouraged by participants. Participants are given a summary sheet each week and optional homework. The metacognition component of the study was created by Steffen Moritz and is freely downloadable from: http://www.uke.de/kliniken/psychiatrie/index_17380.php
- Following the Metacognition component a break, 45 minutes of Mindfulness training is delievered. This consists of 2 x 10 minute mindfulness meditations and a discussion of mindfulness and psychosis inbetween. Participants are given a mindfulness CD and are encouraged to practice mindfulness between each session.
Intervention code [1] 256622 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258590 0
Primary Outcome 1: mean Brief Symptom Inventory Score
Timepoint [1] 258590 0
Timepoints: baselines, 8 and 12 weeks
Primary outcome [2] 258591 0
Primary Outcome 2: mean Psychotic Symptom Rating Scales (PSYRATS) score
Timepoint [2] 258591 0
Timepoints: basline, 8 and 12 weeks
Primary outcome [3] 258592 0
Primary Outcome 3: mean Southampton Mindfulness Questionnaire score
Timepoint [3] 258592 0
Timepoints: basline, 8 and 12 weeks
Secondary outcome [1] 264485 0
Secondary Outcome 1: Mean Metacogniton-30 questionnaire score
Timepoint [1] 264485 0
Baslines, 8 and 12 weeks

Eligibility
Key inclusion criteria
Diagnosis of Psychosis.
Individuals are recruited from the 'Early Episode Psychosis' program of Peel, Rockingham and Kwinana Mental health Service. The program treats individuals between the ages of 18-40 years experiencing their first known psychotic episode and aims to improve quality of life, reduce relapse rates and duration of illness by early sustained treatment.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently Acute Individuals - defined in the study as individuals who received treatment for psychosis in an inpatient setting within 28 days of the group intervention begining.
NB: However, if a participants treating psychiatrist feels that an individual is in the recovery or maintenance phase of psychosis and would benefit from the group intervention, then they may be included in the study even if they were in an inpatient setting 28 days prior to the group beginning

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257110 0
Self funded/Unfunded
Name [1] 257110 0
Country [1] 257110 0
Primary sponsor type
University
Name
Murdoch univeristy
Address
90 Murdoch Drive
Murdoch
WA
6150
Country
Australia
Secondary sponsor category [1] 256372 0
Government body
Name [1] 256372 0
Rockingham Kwinana Mental Health Service
Address [1] 256372 0
Ameer Street
Rockingham
WA
6168
Country [1] 256372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259150 0
Murdoch University Human Ethics Committee
Ethics committee address [1] 259150 0
Ethics committee country [1] 259150 0
Australia
Date submitted for ethics approval [1] 259150 0
Approval date [1] 259150 0
14/05/2010
Ethics approval number [1] 259150 0
2010/098

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

Contacts
Principal investigator
Name 31268 0
Address 31268 0
Country 31268 0
Phone 31268 0
Fax 31268 0
Email 31268 0
Contact person for public queries
Name 14515 0
Chris Hepworth
Address 14515 0
189 Royal Street
Office of the Chief Psychiatrist
Department of Health
East Perth
WA
6004
Country 14515 0
Australia
Phone 14515 0
+61892224492
Fax 14515 0
Email 14515 0
[email protected]
Contact person for scientific queries
Name 5443 0
Chris Hepworth
Address 5443 0
189 Royal Street
Office of the Chief Psychiatrist
Department of Health
East Perth
WA
6004
Country 5443 0
Australia
Phone 5443 0
+61892224492
Fax 5443 0
Email 5443 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.