Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000211268
Ethics application status
Approved
Date submitted
24/04/2009
Date registered
27/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Effectiveness of using Mindfulness-Based Cognitive Therapy to Improve Coping and Quality of Life for Adults who Stutter
Scientific title
Clinical Effectiveness of using Mindfulness-Based Cognitive Therapy to Improve Coping and Quality of Life for Adults who Stutter
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 4488 0
Coping 4657 0
Condition category
Condition code
Other 4769 4769 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 4962 4962 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-Based Cognitive Therapy (MBCT).
Mindfulness is a technique or "mode of being" that is about accepting and being content in the present moment with a non-judgemental and curious attitude. The MBCT group program involves attending 8-weekly group therapy sessions (2 hour duration). Groups will consist of a maximum of 10 participants at any one time. The group program is modified and adapted from Jon Kabat-Zinn's Mindfulness Based Stress Reduction (MBSR) work.
Intervention code [1] 4238 0
Treatment: Other
Comparator / control treatment
Waitlist Controls will not be required to change their daily routines over a 10 week period. At the end of this 10 week period they will be offered the opportunity to participate in the MBCT group program that will be exactly the same as that received by the participants in the MBCT group program condition.
Control group
Active

Outcomes
Primary outcome [1] 5632 0
Improvements in i) stuttered severity (% syllables stuttered), ii) speakers reactions to their stuttering; iii) communication in daily situations; and iv) quality of life. Each of these outcomes will be measured using the "Overall Assessment of the Speaker's Experience of Stuttering (OASES)" standardized questionnaire.
Timepoint [1] 5632 0
One week prior to commencement of MBCT group program (initial interview), Week 8 (final group session) and 3-months followup.
Secondary outcome [1] 241509 0
Improvements in Mindfulness Skills utilized by the participants which will be measured by the "Mindfulness Attention Awareness Scale (MAAS)" questionnaire.
Timepoint [1] 241509 0
One week prior to commencement of MBCT group program (initial interview), Week 8 (final group session) and 3-months followup.

Eligibility
Key inclusion criteria
40 adults who stutter who have been diagnosed by a speech pathologist experienced in the assessment and diagnosis of the disorder of stuttering
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who suffer from delusional or psychotic thinking or have a significant cognitive deficit

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
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4842 0
University
Name [1] 4842 0
Neurotrauma Research Program Grant (WAIMR)
Country [1] 4842 0
Australia
Primary sponsor type
University
Name
WA Institue of Medical Research (WAIMR)
Address
University of Western Australia
B Block, Sir Charles Gairdner Hospital
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 4223 0
None
Name [1] 4223 0
Address [1] 4223 0
Country [1] 4223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6898 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [1] 6898 0
Ethics committee country [1] 6898 0
Australia
Date submitted for ethics approval [1] 6898 0
Approval date [1] 6898 0
Ethics approval number [1] 6898 0
HR 182/2008

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

Contacts
Principal investigator
Name 29410 0
Address 29410 0
Country 29410 0
Phone 29410 0
Fax 29410 0
Email 29410 0
Contact person for public queries
Name 12657 0
Dr Michelle Byrnes
Address 12657 0
School of Psychology
Curtin University of Technology
GPO Box U1987
WA 6845
Country 12657 0
Australia
Phone 12657 0
+61 8 9266 2366
Fax 12657 0
Email 12657 0
[email protected]
Contact person for scientific queries
Name 3585 0
Dr Michelle Byrnes
Address 3585 0
School of Psychology
Curtin University of Technology
GPO Box U1987
WA 6845
Country 3585 0
Australia
Phone 3585 0
+61 8 9266 2366
Fax 3585 0
Email 3585 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.