Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000383662
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
14/04/2023
Date last updated
6/07/2024
Date data sharing statement initially provided
14/04/2023
Date results provided
18/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease: A Feasibility Trial of the Mind4IBD Program
Scientific title
An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease in Adults: A Feasibility Trial of the Mind4IBD Program
Secondary ID [1] 309318 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
MIND4IBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 329508 0
Crohn's Disease 329509 0
Ulcerative Colitis 329510 0
Condition category
Condition code
Alternative and Complementary Medicine 326442 326442 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 326443 326443 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 326444 326444 0 0
Crohn's disease
Oral and Gastrointestinal 326445 326445 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MIND4IBD Intervention: Mindfulness is commonly defined as “paying attention in a particular way, on purpose, in the present moment and non-judgmentally to the unfolding of experience moment by moment”. Mindfulness has also been defined as a “mental engagement that introduces a space in-between one’s perception and response, which helps to regulate how an individual relates to that experience rather than attempting to change the experience themselves”. Ultimately mindfulness-based interventions aim to foster non-judgmental awareness of emotions, thoughts, and behaviour, supporting individuals to respond to their experiences in more adaptive ways, instead of reacting in an automatic habitual pattern. The core components of MBI’s typically include psychoeducation, mindfulness meditation, and mindfulness activities. Our intervention is consistent with the core principles and components of mindfulness. Our intervention is also tailored to people with Inflammatory Bowel Disease (IBD) in several ways. Research has shown that people with IBD experience unique disease related worries related to concerns surrounding QoL (e.g., travelling, toilet frequency), unpredictability (of flares in symptoms), the symptoms themselves (e.g., fatigue, pain), and treatment concerns (e.g., medication side effects). The intervention will incorporate these unique disease related worries within intervention modules themselves. We will also provide psychoeducation surrounding the brain-gut connection in IBD. Our 6-week MIND4IBD intervention includes six fully scripted modules, each addressing different mindfulness themes or principles. All modules are self-led and delivered wholly online via a website, and include written material, video and/or voice recordings. Participants are asked to complete one module a week over 6-weeks, with modules lasting no longer than 30 minutes. As the intervention is delivered through a website, website analytics will be used to monitor adherence to the intervention. The contents of the modules will include an introduction to mindfulness, stress reduction using mindfulness, relating to emotions mindfully, mindful self-compassion, communicating mindfully, and living mindfully.
Intervention code [1] 325752 0
Behaviour
Intervention code [2] 325753 0
Treatment: Other
Comparator / control treatment
A Wait-List-Control Group where participants will have access to the intervention upon completion of the study, all participants will however remain on their treatment-as-usual. (In this instance participation in the intervention is independent of participants regular treatment outside of the study (e.g. seeing their gastroenterologist, regular medications, etc.)
Control group
Active

Outcomes
Primary outcome [1] 334291 0
Feasibility of recruitment and retention assessed based on descriptive study data. This will be based on study recruitment records.
Timepoint [1] 334291 0
Upon intervention completion (6 weeks post baseline).
Primary outcome [2] 334292 0
Acceptability of the intervention based on levels of satisfaction measured through numeric rating scale and qualitative open ended survey responses regarding the intervention. These survey measures have been designed specifically for this study.
Timepoint [2] 334292 0
Upon intervention completion (6 weeks post baseline).
Secondary outcome [1] 420152 0
Change in patient distress level based on Depression, Anxiety, Stress Scale (DASS).
Timepoint [1] 420152 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [2] 420153 0
Change in mindfulness levels based on the Five Facet Mindfulness Questionnaire (FFMQ-15).
Timepoint [2] 420153 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [3] 420154 0
Change in Quality of life based on The World Health Organisation Quality of Life (WHOQOL-BREF)
Timepoint [3] 420154 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [4] 420155 0
Change in coping based on the Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE).
Timepoint [4] 420155 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [5] 420156 0
Change in resilience based on the Brief Resilience Scale (BRS).
Timepoint [5] 420156 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [6] 420157 0
Change in disease activity levels based on the Manitoba IBD Index (MIBDI).
Timepoint [6] 420157 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [7] 420158 0
Change in fatigue levels based on the Fatigue Symptom Inventory (FSI).
Timepoint [7] 420158 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [8] 420159 0
Change in pain levels based on the numeric rating pain scale.
Timepoint [8] 420159 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [9] 420536 0
Change in disease activity levels based on adapted patient reported outcomes for Ulcerative Colitis (PRO2).
Timepoint [9] 420536 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [10] 420537 0
Change in disease activity levels based on the adapted patient reported outcomes for Crohn's Disease (PRO3).
Timepoint [10] 420537 0
Baseline and upon intervention completion (6 weeks post baseline).
Secondary outcome [11] 420538 0
Change in visceral sensitivity and pain catastrophizing based on the gastrointestinal Unhelpful Thinking Scale (GUTS).
Timepoint [11] 420538 0
Baseline and upon intervention completion (6 weeks post baseline).

Eligibility
Key inclusion criteria
- Adults aged 18 years or older.
- Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility.
- Evidence of moderate to high psychological distress. This will be verified by a score between 16-29 on K10. Screening for distress will take place after consent has been obtained.
- Able to communicate in English.
- Access to the internet to participate in the online intervention.
- Live in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No/low psychological distress (represented by scores <16 on K10) or very high psychological distress (represented by scores >29 on K10). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress.

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)
Random allocation will occur through computer generated sequences through the Qualtrics randomization feature ensuring allocation concealment. This will be stratified by IBD activity (via scores on the MIBDI).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will occur through block randomization sequence with variable block size. This will be stratified by IBD activity (via scores on the MIBDI).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be quantitative and will be carried out on an intention-to-treat basis.
Primary outcomes:
Descriptive statistics will be provided for feasibility and acceptability outcomes.
Secondary Outcomes:
For preliminary efficacy we will attempt to run a group comparison on the secondary outcome measures with linear mixed effects models which enable retention of participants with missing data, under the assumption that data are missing at random. In these models, the dependent variable is the outcome measure, with predictors being Time, Group and the Interaction between Time and Group - the coefficient for Interaction being the formal test of preliminary efficacy. Primary analyses will be conducted unadjusted, with significance tests will be two-sided at the 5% level. No adjustment for multiple testing will be made to p-values; however, effect sizes for each outcome measure will be presented.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2023
Actual
28/10/2023
Date of last participant enrolment
Anticipated
1/07/2024
Actual
1/04/2024
Date of last data collection
Anticipated
20/09/2024
Actual
20/05/2024
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313514 0
University
Name [1] 313514 0
Deakin University
Country [1] 313514 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
227 Burwood Highway, Burwood, VIC, Australia, 3125.
Country
Australia
Secondary sponsor category [1] 315289 0
None
Name [1] 315289 0
Address [1] 315289 0
Country [1] 315289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312701 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312701 0
Ethics committee country [1] 312701 0
Australia
Date submitted for ethics approval [1] 312701 0
20/04/2023
Approval date [1] 312701 0
22/06/2023
Ethics approval number [1] 312701 0
2023-119

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

Contacts
Principal investigator
Name 125602 0
Prof Antonina Mikocka-Walus
Address 125602 0
School of Psychology, Deakin University. 221 Burwood Highway, Burwood, VIC, Australia, 3125.
Country 125602 0
Australia
Phone 125602 0
+61 392468575
Fax 125602 0
Email 125602 0
[email protected]
Contact person for public queries
Name 125603 0
Colette Naude
Address 125603 0
School of Psychology Deakin University. 221 Burwood Highway, Burwood, VIC, Australia, 3125.
Country 125603 0
Australia
Phone 125603 0
+61 392446100
Fax 125603 0
Email 125603 0
[email protected]
Contact person for scientific queries
Name 125604 0
Antonina Mikocka-Walus
Address 125604 0
School of Psychology, Deakin University. 221 Burwood Highway, Burwood, VIC, Australia, 3125.
Country 125604 0
Australia
Phone 125604 0
+61 392468575
Fax 125604 0
Email 125604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will only be sharing unidentified aggregated data to protect the privacy of our participants.


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.