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Trial registered on ANZCTR


Registration number
ACTRN12615000946516
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
9/09/2015
Date last updated
9/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Does Kindness Matter?" Increasing self-compassion among diabetes patients
Scientific title
"Does Kindness Matter?" A Randomized Controlled Trial investigating the role of self-compassion in reducing depression and improving compliance in diabetes patients.
Secondary ID [1] 284890 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 292337 0
Depression 292338 0
Compliance 292339 0
Metabolic outcomes 292340 0
Condition category
Condition code
Metabolic and Endocrine 292669 292669 0 0
Diabetes
Mental Health 292728 292728 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An eight-week intervention using a mindful self-compassion intervention in which participants will attend a total of eight sessions, two and a quarter hours in duration, conducted once a week. The sessions will be administered in a group setting by a psychologist trained to deliver this intervention
Intervention code [1] 289703 0
Behaviour
Comparator / control treatment
Waitlist control. The Waitlist Control group will be offered intervention once the three month follow-up of the intervention group is completed
Control group
Active

Outcomes
Primary outcome [1] 292513 0
Self-compassion as assessed by Self-Compassion Scale (Neff, 2003)
Timepoint [1] 292513 0
Baseline, at four weeks, at completion of intervention and 3 months after intervention is completed.
Primary outcome [2] 292514 0
Depression as assessed by PHQ-9
Timepoint [2] 292514 0
Baseline, at four weeks, at completion of intervention and 3 months after intervention is completed.
Primary outcome [3] 292528 0
Diabetes self-care activities (diet, exercise, blood glucose, self monitoring), using Diabetes Self Care Activities Scale
Timepoint [3] 292528 0
Baseline, at four weeks, at completion of intervention and 3 months after intervention is completed.
Secondary outcome [1] 309130 0
HbA1c as assessed by blood test
Timepoint [1] 309130 0
Baseline, at four weeks, at completion of intervention and 3 months after intervention is completed.

Eligibility
Key inclusion criteria
Patients with a diagnosis of Type 1 or Type 2 Diabetes Mellitus over the age of 18. Participants must also be English-speaking
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking
Under 18

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine eligibility for this trial will be unaware of allocation to group, as the allocation decision will be made after participants have been enrolled in the study. Allocation will be concealed by randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A person independent of the study (a doctoral student with no contact at all with study participants) will do the randomization and allocation of treatment, using a randomization table created by computer software. They will then put this information into a sealed envelope so that it cannot be influenced.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analyzed using mixed model MANOVA to test for differences between control and experimental conditions in levels of self-compassion.Second, to investigate whether self-compassion predicts levels of depression, distress and adherence behaviors and HbA1c, general linear model analyses will be conducted.

Fifty participants will recruited. While, to our knowledge, there has been no research involving the mindful self compassion programme in diabetes patients, a previous study by Neff and Germer (2013), in a physically healthy population, reported results of a randomized controlled study, reporting a large effect size of MSC group participation (N= 27 for treatment group, N = 25 for waitlist control), with significant large improvements in depression (d = .86,) and self-compassion (d = 1.67), and medium effects in anxiety (d = .76), stress (d = .37), and overall life satisfaction (d = .51) in the intervention group, compared to control.


Recruitment
Recruitment status
Active, not recruiting
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 outside Australia
Country [1] 6187 0
New Zealand
State/province [1] 6187 0
Auckland

Funding & Sponsors
Funding source category [1] 289527 0
University
Name [1] 289527 0
University of Auckland
Address [1] 289527 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
Country [1] 289527 0
New Zealand
Funding source category [2] 289528 0
Charities/Societies/Foundations
Name [2] 289528 0
New Zealand Society for Study of Diabetes
Address [2] 289528 0
Department of Medicine
9th floor Dunedin Public Hospital
PO Box 913
Dunedin 9016

Country [2] 289528 0
New Zealand
Primary sponsor type
Individual
Name
Anna Friis
Address
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 288213 0
Individual
Name [1] 288213 0
Associate Professor Nathan Consedine
Address [1] 288213 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country [1] 288213 0
New Zealand
Secondary sponsor category [2] 288214 0
Individual
Name [2] 288214 0
Malcolm Johnson
Address [2] 288214 0
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142, New Zealand
Country [2] 288214 0
New Zealand
Secondary sponsor category [3] 288215 0
Individual
Name [3] 288215 0
Dr Rick Cutfield
Address [3] 288215 0
Diabetes Service
North Shore Hospital
Private Bag 93 503
Takapuna
North Shore City 0740
Auckland
Country [3] 288215 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291268 0
Health and Disability Ethics Committee
Ethics committee address [1] 291268 0
Ministry of Health
c/- Medsafe, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 291268 0
New Zealand
Date submitted for ethics approval [1] 291268 0
Approval date [1] 291268 0
03/02/2014
Ethics approval number [1] 291268 0

Summary
Brief summary
This study is a randomized controlled trial in diabetes patients comparing mindful self-compassion training with a wait list control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49562 0
Ms Anna Friis
Address 49562 0
The University of Auckland Department of Psychological Medicine Faculty of
Medical and Health Sciences Private Bag 92019 Auckland 1142, New
Zealand
Country 49562 0
New Zealand
Phone 49562 0
+64 274 999 696 or +64 9 373 7599 x 84938
Fax 49562 0
Email 49562 0
a.friis@auckland.ac.nz
Contact person for public queries
Name 49563 0
Ms Anna Friis
Address 49563 0
The University of Auckland Department of Psychological Medicine Faculty of
Medical and Health Sciences Private Bag 92019 Auckland 1142, New
Zealand
Country 49563 0
New Zealand
Phone 49563 0
+64 274 999 696 or +64 9 373 7599 x 84938
Fax 49563 0
Email 49563 0
a.friis@auckland.ac.nz
Contact person for scientific queries
Name 49564 0
Ms Anna Friis
Address 49564 0
The University of Auckland Department of Psychological Medicine Faculty of
Medical and Health Sciences Private Bag 92019 Auckland 1142, New
Zealand
Country 49564 0
New Zealand
Phone 49564 0
+64 274 999 696 or +64 9 373 7599 x 84938
Fax 49564 0
Email 49564 0
a.friis@auckland.ac.nz

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