Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000898752
Ethics application status
Approved
Date submitted
8/08/2013
Date registered
12/08/2013
Date last updated
12/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the effectiveness of a mindfulness-based intervention to reduce distress in people with diabetes
Scientific title
Testing the effectiveness of a mindfulness-based intervention to reduce distress in people with diabetes: A pilot study
Secondary ID [1] 282969 0
Nil Known
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes distress 289792 0
Condition category
Condition code
Mental Health 290146 290146 0 0
Other mental health disorders
Metabolic and Endocrine 290147 290147 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A CD of guided mindfulness practice to be performed each day for 8 weeks at home. The duration of the daily practice is 30 minutes and participants are required to fill in a daily practice record. The intervention CD consists of a fully guided mindfulness session about the process of placing your attention on your breath. It is the same each day.
Intervention code [1] 287677 0
Behaviour
Intervention code [2] 287723 0
Treatment: Other
Comparator / control treatment
Participants in the control group receive the standard usual care they would normally receive from the diabetes education clinics. The dummy CD simply contains an empty CD case with a label indicating they are allocated to the control group.
Control group
Active

Outcomes
Primary outcome [1] 290172 0
Depression, Anxiety and Stress scale (DASS)
Timepoint [1] 290172 0
Measured at baseline and 8 and 16 weeks post-consent
Primary outcome [2] 290173 0
Problem Areas in Diabetes Survey (PAID)
Timepoint [2] 290173 0
Measured at baseline and 8 and 16 weeks post consent
Secondary outcome [1] 304049 0
Summary of Diabetes Self-Care activities
Timepoint [1] 304049 0
Measured at baseline, 8 and 16 weeks post consent
Secondary outcome [2] 304050 0
Diabetes-specific mindfulness measured with the Acceptance and Action Diabetes questionnaire (AADQ)
Timepoint [2] 304050 0
Measured at baseline, 8 and 16 weeks post consent
Secondary outcome [3] 304051 0
HbA1c will be measured using a point-of-care device while attending the Diabetes clinic.
Timepoint [3] 304051 0
Baseline and 16 weeks
Secondary outcome [4] 304052 0
Blood pressure will be measured using an automatic sphygmomanometer
Timepoint [4] 304052 0
Baseline, 8 and 16 weeks

Eligibility
Key inclusion criteria
Type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current regular practice of mindfulness
Recent history of severe psychopathology
Insufficient reading or comprehension skills or incapable of signing the informed consent
A K10 score > 30

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)
Allocation was concealed. Following consent participants received a sealed numbered envelope containing either a treatment CD or dummy CD.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was used using a computerised sequence generation
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
Analysis will be performed on an intention-to-treat basis. Multivariable analysis will be used to account for correlated readings within each individual over time and examine the association between each outcome and study arm. Baseline values will be treated as covariates rather than a response variable in the model. Thus, we will test whether outcome measures at 8 and 16 weeks differ between conditions controlling for baseline scores and other covariates that are identified as influencing the outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 1428 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 7263 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 287762 0
University
Name [1] 287762 0
School of Medicine Small Grants Scheme, University of Tasmania
Country [1] 287762 0
Australia
Primary sponsor type
Individual
Name
Dr Sue Pearson
Address
Medical Science 2 Building
University of Tasmania
Private Bag 34, Hobart TAS 7000 Australia
Country
Australia
Secondary sponsor category [1] 286488 0
Individual
Name [1] 286488 0
Associate Professor Emma Warnecke
Address [1] 286488 0
Medical Science 2 Building
University of Tasmania
Private Bag 34, Hobart TAS 7000 Australia
Country [1] 286488 0
Australia
Other collaborator category [1] 277571 0
Individual
Name [1] 277571 0
Dr Michelle Woods
Address [1] 277571 0
Royal Hobart Hospital Diabetes Centre
70 Collins Street, Level 5
Hobart, Tas 7000
Country [1] 277571 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289708 0
Human Research Ethics Committee (Tasmania Network)
Ethics committee address [1] 289708 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, TAS, 7001
Ethics committee country [1] 289708 0
Australia
Date submitted for ethics approval [1] 289708 0
Approval date [1] 289708 0
09/07/2013
Ethics approval number [1] 289708 0
H0012761

Summary
Brief summary
Mindfulness-based intervention programs are a promising intervention in the treatment of psychological distress in a range of clinical populations including pain disorders, cancer and other medical problems. There is, however a paucity of studies that have examined mindfulness in people with diabetes. The few studies that have been undertaken have shown the intervention to result in improvements in emotional well-being (anxiety and depression), improved self-care behaviours and decreased HbA1c values.

This study will assess the effects of a mindfulness-based intervention undertaken and self-directed in people with diabetes at home over an eight-week period.

This study will seek to determine whether a mindfulness-intervention undertaken in the patients’ home can:
Reduce anxiety and depression
Reduce perceived diabetes –specific stress
Improve diabetes self-care and management
Improve glycemic control (HbA1c)
Increase mindfulness strategies (acceptance and action) in relation to diabetes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42006 0
Dr Sue Pearson
Address 42006 0
17 Liverpool Street
Medical Science 2 Building
University of Tasmania
Private Bag 34, Hobart TAS 7000
Country 42006 0
Australia
Phone 42006 0
+61 3 62264712
Fax 42006 0
Email 42006 0
[email protected]
Contact person for public queries
Name 42007 0
Dr Sue Pearson
Address 42007 0
17 Liverpool Street
Medical Science 2 Building
University of Tasmania
Private Bag 34, Hobart TAS 7000
Country 42007 0
Australia
Phone 42007 0
+61 3 62264712
Fax 42007 0
Email 42007 0
[email protected]
Contact person for scientific queries
Name 42008 0
Dr Sue Pearson
Address 42008 0
17 Liverpool Street
Medical Science 2 Building
University of Tasmania
Private Bag 34, Hobart TAS 7000
Country 42008 0
Australia
Phone 42008 0
+61 3 62264712
Fax 42008 0
Email 42008 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.