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Trial registered on ANZCTR


Registration number
ACTRN12618002009291
Ethics application status
Approved
Date submitted
7/12/2018
Date registered
14/12/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of mindfulness in promoting wellbeing in patients with Crohn’s disease:
An exploratory randomised control trial
Scientific title
The role of mindfulness based stress reduction in restoring mood homeostasis and reducing symptoms of depression, stress and inflammation in patients with Crohn’s disease: An exploratory randomised control trial
Secondary ID [1] 296151 0
None
Universal Trial Number (UTN)
U1111-1220-8416
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 309749 0
Depression 309750 0
Stress 309751 0
Condition category
Condition code
Inflammatory and Immune System 308551 308551 0 0
Other inflammatory or immune system disorders
Mental Health 309469 309469 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An eight week training in Mindfulness Based Stress Reduction consisting of 2.5 hours of instruction per week and 45 minutes per day of home practice. The course will utilize the materials from palousemindfulness.com (permission has been sought and received from the site owner), which include video and written materials. Mindfulness practices include mindful eating, body scans, focused breathing and gentle yoga poses. These are conducted during the sessions and in home practice tasks. The palousemindfulness course is designed to be self-directed; however in this case the participants will meet as a group with a university student (doctoral student in clinical psychology) acting as facilitator. Maximum group numbers will be 10 per group. The group will be conducted in a meeting room at the rooms of the gastroenterologist (Dr Lauren Beswick) associated with the study. Each week participants will be given homework sheets to record their home practice; these will be collected and the times recorded as part of the data collection. The intervention is in addition to the standard care each patient will receive as part of their ongoing treatment with the gastroenterologist.
Intervention code [1] 312477 0
Treatment: Other
Comparator / control treatment
Standard care.They will continue to get care and treatment as usual, according to their individual needs and as determined by their gastroenterologist. They will be offered the opportunity to participate in the same Mindfulness Based Stress Reduction Course that the intervention group received. The course will be offered to the control group in 2020, which will be following the 6 month follow up period of the data collection phase.
Control group
Active

Outcomes
Primary outcome [1] 308360 0
depression symptoms as determined by measurements on the Depression Anxiety and Stress Scale (Lovibond & Lovibond 1995)
Timepoint [1] 308360 0
Immediate post-intervention and six=month follow up
Secondary outcome [1] 354724 0
Homeostatically Protected Mood variability. This will be tested through a series of statistical analyses to participants answers to questions, how happy/content/alert they feel during a tw0-week ecological momentary assessment period. The statistical analyses will include within-person standard deviation, mean successive square differences and multi-level-modelling.
Timepoint [1] 354724 0
immediately post intervention and at six month follow up
Secondary outcome [2] 354725 0
Inflammation levels through levels of C-reactive protein. These will be accessed through blood test results. Blood samples will be collected by the patient’s gastroenterologist as part of usual care.
Timepoint [2] 354725 0
immediately post-intervention and at six month follow up
Secondary outcome [3] 354726 0
stress symptoms as determined by measurements on the Depression Anxiety and Stress Scale (Lovibond & Lovibond 1995)
Timepoint [3] 354726 0
immediately following intervention and at 6 month follow up

Eligibility
Key inclusion criteria
1) A clinically established diagnosis of Crohn’s disease (per usual clinical practice in a tertiary care centre)
2) Sufficient knowledge of English to understand the study instructions, answer the questionnaires and participate in the Mindfulness Based Stress Reduction group (MBSR). Note; as this is an exploratory study and involves a group intervention, it will not be possible to conduct the MBSR intervention in any language other than English.
3) 18 years of age or older
4) Competence to consent
5) Access to the internet by a smart phone and the willingness to download the Instant Survey app.
6) A willingness to commit to 2.5 hours of MBSR at the identified times for a period of 8 consecutive or near-consecutive weeks, and engage with the homework sheets in the intervening period.
7) Scores of depression at mild or moderate levels of the DASS scale
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Alcohol/substance dependence, as identified by the gastroenterology team
2) Severe mental illness (e.g. psychosis, schizophrenia), as identified by the gastroenterology team
3) Severe anxiety or depressive symptoms as indicated by a scores >21 on the depression scale or > 15 on the anxiety scale of the DASS measure
4) Significant cognitive impairment
5) Inability to read or write
6) Inability to speak or understand English (see note above)
7) A regular (weekly or more often) mindfulness practice.

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)
Patients meeting the inclusion criteria and providing consent to participate in the trial will be randomly assigned to either group A (mindfulness) or group B (waitlist/usual care). Patients in both groups will continue to receive their current treatment for their Crohn's disease. A researcher who will have no patient contact will be responsible for sequence generation and for preparing sealed envelopes in the allocation order. Those envelopes will be provided sequentially to patients meeting the selection criteria following the screening process.

Patients in Group A will receive the intervention in 2018 and will be required to provide subjective mood data via an app for two weeks prior to and two weeks following the 8-week intervention. Patients in Group B will receive an opportunity to attend a mindfulness course in 2020 and will be required to provide the same subjective mood data via an app for a period in 2019 that will parallel the data collection for Group A. Patients who have been allocated to Group A will be provided with two choices for mindfulness group meeting times and days. If neither time is convenient for them, they will be removed from the trial.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated matrix of numbers in blocks of 4.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The intervention involves participation in an 8-week mindfulness course, it is therefore not possible for it to be a blinded trial.

The data will be analyzed by the student researcher responsible for delivering the intervention.



Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Mixed ANOVA, clinical significance testing.

Recruitment
Recruitment status
Not yet 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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12671 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 12672 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment postcode(s) [1] 25093 0
3220 - Geelong
Recruitment postcode(s) [2] 25094 0
3215 - North Geelong

Funding & Sponsors
Funding source category [1] 300738 0
University
Name [1] 300738 0
Deakin University
Address [1] 300738 0
Deakin University School of Psychology
221 Burwood Highway
Burwood, Vic 3125
Australia
Country [1] 300738 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Psychology, Faculty of Health
221 Burwood Highway
Burwood, Vic 3125
Australia
Country
Australia
Secondary sponsor category [1] 301069 0
None
Name [1] 301069 0
Address [1] 301069 0
Country [1] 301069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301520 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 301520 0
Research Ethics, Governance & Integrity (REGI) Unit, Barwon Health
Post. PO Box 281 Geelong 3220
Email: REGI@barwonhealth.org.au
Phone: (03) 4215 3372
Ethics committee country [1] 301520 0
Australia
Date submitted for ethics approval [1] 301520 0
26/09/2018
Approval date [1] 301520 0
27/11/2018
Ethics approval number [1] 301520 0
18/182

Summary
Brief summary
The study aims to contribute to understanding of the relationship between stress and inflammation. It is thought that, during period of high psychological stress and inflammation, an individual's inner homeostatic system that controls mood and emotional regulation is challenged such that homeostasis is no longer functional. The study will explore whether a mindfulness intervention can aid in the restoration of homeostasis, and, if so, whether this restoration is also associated with a reduction in inflammation, perceived stress levels and symptoms of depression.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 87270 0
A/Prof Antonina Mikocka-Walus
Address 87270 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway
Burwood VIC 3125

Country 87270 0
Australia
Phone 87270 0
+61 3 9246 8575
Fax 87270 0
Email 87270 0
mikocka@deakin.edu.au
Contact person for public queries
Name 87271 0
Ms Kimina Lyall
Address 87271 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 87271 0
Australia
Phone 87271 0
+61 3 924 46345
Fax 87271 0
Email 87271 0
klyall@deakin.edu.au
Contact person for scientific queries
Name 87272 0
A/Prof Antonina Mikocka-Walus
Address 87272 0
School of Psychology, Faculty of Health, Deakin University
221 Burwood Highway
Burwood VIC 3125

Country 87272 0
Australia
Phone 87272 0
+61 3 9246 8575
Fax 87272 0
Email 87272 0
mikocka@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics has been approved with the data only being available for this study.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Attachments/websites
Type [1] 666 0
Ethical approval
URL/details/comments [1] 666 0
Summary results
Not applicable