ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000876392

Ethics application status

Approved

Date submitted

12/06/2017

Date registered

15/06/2017

Date last updated

2/03/2020

Date data sharing statement initially provided

18/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

IBDmindfulness-mindfulness for youth with Inflammatory Bowel Disease (IBD) and depression trial

Scientific title

A pilot randomised-controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) for youth with Inflammatory Bowel Disease (IBD) and Depression

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1197-7370

Trial acronym

IBDmindfulness

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Inflammatory Bowel Disease

Condition category

Condition code

Mental Health

Depression

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention delivered in the study will be Mindfulness-Based Cognitive Therapy (MBCT), a group psychological intervention, delivered face-to-face to groups of 8-10 participants in 2-hours long weekly sessions, over a period of eight weeks. MBCT will be delivered by an experienced mindfulness teacher, trained in MBCT and MBSR up to a teacher level and with four years post teacher training experience as well as experience running several previous mindfulness group courses for people with chronic illness.

MBCT is designed to help people who suffer repeated bouts of depression by cultivating mindfulness and learning about habitual thinking patterns that make us vulnerable to depression.. It uses a combination of psycho-education, mindfulness practices of focused attention without judgement and cognitive techniques including meta-cognitive processes to assist with disengaging from maladaptive ways of coping and thinking. .It's proven to be effective in both preventing and treating depression.

Participants will be recruited via the IBD outpatient services at Mater Young Adult Health Centre Brisbane. The MBCT will be conducted at Mater Young Adult Health Centre, an urban tertiary hospital specializing in treatment of young adults aged 16-25 with chronic illness.
. A subset of participants will receive the fMRI scans, and these will be performed at The Centre for Advanced Imaging (CAI) on the St Lucia campus of the University of Queensland. At all other times, participants will be treated as per standard care at Mater South Brisbane.

Following recruitment, participants will be randomly allocated to either treatment as usual (TAU-control group) or an intervention group (INT group) who will receive the MBCT. Participants in the intervention group will attend two hours of weekly group mindfulness-based cognitive therapy, and a subset of this group will be asked to undergo MRI scans (16 from the intervention group and 16 from the control group). All participants will be asked to complete questionnaires, and this will be collated with routinely collected clinical data.
MBCT intervention will be adapted to suit the young age of participants and also their IBD symptoms which could necessitate shorter practices due to pain and other GI symptoms (e.g. urgency to go to the toilet, fatigue etc)... In particular, mindfulness practices will be shortened (e.g. 20 minutes instead of 30 minutes body scan or mindfulness of the breath) while trying to maintain the recommended "daily dose" of mindfulness practices through introducing additional shorter practices and making practices more youth friendly (e.g. youth relevant poetry, use of language and themes)..Psycho-educational component of the course will be expanded to include a module on IBD and its interaction with stress and mood.Intervention adherence or fidelity will be assessed,by participants having a weekly log of mindfulness practice including type of practice,amount of time practiced and any reflections barriers to practice. All weekly group sessions will be video recorded and later assessed by an external, experienced MBCT teacher to ensure adherence to MBCT session conducting guidelines.
All participants who completed the MBCT program will be offered optional participation in focus groups assessing their MBCT experiences.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Participants will be randomly allocated to either treatment as usual (TAU-control group) or an intervention group (INT group) who will receive the MBCT. Participants in the control group will receive psychosocial treatment via the Young Adult Support Unit (YASU), a multidisciplinary team providing psychosocial services to young adults with mental health concerns who are current patients at Mater Young Adult Health Centre .The treatment might involve talking therapy, medication or psychological support, depending on the severity and nature of their mental health concerns.Participants in the control group will also get supportive phone calls from the research assistant and handouts or emails providing links to mental health websites (e.g., beyond blue). The research assistant will respond to any questions raised by the participant.s.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure for the study will be the depression subscale score from the Depression, Anxiety and Stress Scale (DASS).

Timepoint [1]

DASS will be administered at the start of the study (prior to starting treatment, at week 0), after the conclusion of the 8 weeks of MBCT program (at week 8), and at 20 weeks.

Secondary outcome [1]

Post traumatic growth inventory (PTGI).

Timepoint [1]

At weeks 0, 8 and 20.

Secondary outcome [2]

IBD related quality of life (SIBDQ,10),

Timepoint [2]

At weeks 0,8 and 20.

Secondary outcome [3]

Illness knowledge (CCKNOW)

Timepoint [3]

At weeks 0,8 and 20.

Secondary outcome [4]

Illness perception (IPQ)

Timepoint [4]

At weeks 0,8 and 20.

Secondary outcome [5]

Coping with illness (COPE)

Timepoint [5]

At weeks 0,8 and 20.

Secondary outcome [6]

Medication adherence (MAQ).

Timepoint [6]

At weeks 0,8 and 20.

Secondary outcome [7]

Self-efficacy for appropriate medication use scale (SEAMS).

Timepoint [7]

At weeks 0,8 and 20.

Secondary outcome [8]

Mindfulness on Five Facets of Mindfulness Questionnaire (FFMQ).

Timepoint [8]

At weeks 0,8 and 20.

Secondary outcome [9]

IBD disease activity questionnaires: a simple clinical colitis activity index (SCAI) for ulcerative colitis and Harvey-Bradshaw Index (HBI) for Crohn's disease activity.

Timepoint [9]

At weeks 0,8 and 20.

Secondary outcome [10]

Inflammatory IBD markers (CRP, ESR, IL-6, faecal calprotectin),
Faecal calprotectin is assessed on stool samples as part of usual care using an ELISA based assay through Mater pathology.
CRP and ESR are assessed on serum samples as part of usual care using Mater Pathology.
IL-6 will be measured in house on serum collected as part of usual care using an commercial ELISA kit.

Timepoint [10]

At weeks 0,8 and 20.

Secondary outcome [11]

Microbiome analysis.
Microbiome analysis will be performed on stool collected on patients as part of usual care through the Australian center for Ecogenomics at the university of Queensland using metagenomic sequencing.

Timepoint [11]

At weeks 0,8 and 20.

Secondary outcome [12]

Small intestinal ultrasound.
Small bowel ultrasound is routinely performed during clinical assessments at the Mater Hospital and wall thickness of colonic segments and terminal ileum measured. These wall thickness values will be recorded for the trial.

Timepoint [12]

At weeks 0,8 and 20.

Secondary outcome [13]

Neural Connectivity changes on functional Magnetic resonance imaging scans (fMRIs).
Participants will be scanned on the 3T MRI scanner at the Centre for Advanced Imaging (CAI), UQ St Lucia Campus with the following protocols:
1. T1-MPRAGE for high resolution structure.
2. T2-FLAIR for detecting brain lesion and small vessel disease
3. resting-state fMRI for functional connectivity
5. diffusion tensor imaging for structural connectivity
The total scan time would be 25 min.

Sixteen participants from each group (intervention group and control group) will undergo fMRIs. The allocation of participants to fMRIs will be random (as specified in the sampling plan with each of the 64 participants already pre-allocated to 8 cells by stratification).As we are planning to use age, gender and depression level (all dichotomous) we’ll end up with 8 cells after stratification (2x2x2).
The participants for fMRIs will be selecting randomly from each of the eight cells created after stratification.

Timepoint [13]

At weeks 0 and 8.

Secondary outcome [14]

Acceptability and feasibility, as indicated by sessions attendance, completion of home practices, recruitment and attrition rates, and participants’ MBCT group experiences assessed through post MBCT evaluation questionnaire and focus groups.

Timepoint [14]

at week 8 for all measures apart from focus groups which will be conducted at any time post MBCT program completion., during the study duration.

Eligibility

Key inclusion criteria

Young adult (aged 16-29);
• Able to verbally communicate and write in English
• Able to give informed consent (for youth aged 16-18 both the participant and their parent/guardian will provide consent)
• Confirmed diagnosis of IBD
• Confirmed clinical diagnosis of depression and DASS depression subscale scores of 10 and above
• Attending the IBD outpatient clinic at the Mater Young Adult Health Centre Brisbane;
• Have access to internet-enabled computer
• Able to do light exercise because this program involves a mindful movement component
• Able to commit to attend the eight weekly sessions of two hours’ duration
• Able to commit to do home practice of up to 45 minutes per day over the 8 weeks of the study as this is a requirement of the program
• No change in antidepressant medication (dose or type) within three months of trial onset

Minimum age

16 Years

Maximum age

29 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Individuals not meeting inclusion criteria will be excluded from the study
• Individuals who do not have conversational or written English;
• Individuals who may have limited or no capacity to self-care; and
• Individuals who have no depression or have extremely severe levels of depression or anxiety
• Individuals with major mental illness other than depression as its treatment as well as symptoms could interfere with their ability to participate in program (e.g. current psychotic symptoms, current PTSD, OCD etc.)
• Individuals with a history of alcohol or drug dependency
• Individuals with current alcohol or drug dependency as substance dependence that would impact on program participation
• Individuals scheduled for major surgery in the next 3 months as this would impact on their ability to attend the program for its entire duration
• Individuals who have been started on antidepressants or changed their antidepressant dose within three months of the study onset
• Individuals enrolled or participating in another psychological therapy study or pharmacological study within the last six months or intending to participate during this study duration
• Exacerbation of IBD symptoms (flare) as this will make it difficult for participants to attend weekly sessions and complete home 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)

Allocation will be concealed as it will be done by central randomisation process by computer software program.
The holder of the allocation schedule will be"off-site",at a different administrative site..

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation will be used. Age, gender and depression level (all dichotomous) will be used for stratification, ending up with 8 cells after stratification (2x2x2).
The allocation of participants to fMRI will be random (as specified in the sampling plan with each of the 64 participants already pre-allocated). Only a portion of participants will be he allocated to fMRI, 16 from each group (control and treatment group) in order to achieve a balanced design by selecting participants randomly from each of the eight cells created after stratification.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Based on researcher experience, we expect 64 participants to be available to participate in the study drop-out rate of 15%. We expect that around 54 participants will complete the study (n=27 intervention group; n=27 control group). The sample size provides 80% power to identify large (Cohen’s D = 0.8) effects. However, given the large effects sizes variability for mindfulness studies, we have decided to run this study as a pilot RCT with aims to assess feasibility, effectiveness of the intervention and provide data for establishing sample size numbers for a definitive large RCT. Proposed sample size of 54 is in keeping with pilot studies samples size guidelines which recommend a sample size of at least 40, and for effectiveness studies,30 participants per arm of the study.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

10/07/2017

Actual

15/09/2017

Date of last participant enrolment

Anticipated

18/09/2019

Actual

23/09/2019

Date of last data collection

Anticipated

31/03/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Adult Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Brain Injured Childrens After-Care Recovery Endeavours (Bicare) Inc

Address [1]

L16/356 Blunder Road Durack QLD 4077 AUSTRALIA

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

The University of Queensland
Brisbane QLD 4072 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee

Ethics committee address [1]

Room 294, Level 2,  Aubigny Place
Raymond Terrace
South Brisbane Qld 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/02/2017

Approval date [1]

05/06/2017

Ethics approval number [1]

HREC/17/MHS/12

Summary

Brief summary

Inflammatory Bowel Disease is an auto-inflammatory disease characterised by chronic inflammation of the gastrointestinal tract and a chronic, relapsing and remitting course.
Individuals with IBD are significantly more likely to suffer from depressive and other emotional health symptoms than age matched individuals in general population as well as people suffering from other chronic illnesses. Research has shown that individuals with IBD have triple the rate of mental disorders than that of general population. In particular, youth with IBD had higher rates of depressive disorders than youth with other chronic conditions, lower parent- and youth-reported QOL, and lower youth-reported social functioning compared to healthy youth.Research to date identifies that psychological interventions involving IBD cohorts are effective in reducing psychological distress (e.g., anxiety and/or depression), with cognitive behaviour therapy having the most evidential support. More recently, mindfulness based interventions have been found to reduce anxiety and depression and enhance quality of life]. The aim of this study is to conduct a randomised controlled trial (RCT) exploring the potential benefit of a group, IBD-focused, mindfulness-based cognitive therapy (MBCT) for youth living with IBD and comorbid depression. This randomised trial will also explore the potential benefit of the mindfulness intervention on immune markers associated with IBD and functional neuroimaging changes in response to the mindfulness intervention to provide insight in the mechanisms of action of this intervention.
HYPOTHESES 
1.	MBCT (intervention group) will improve depression scores (pre-post); 
2.	Intervention will increase quality of life, mindfulness, medication adherence, perceived health care empowerment, coping and perceived illness perceptions and it will reduce anxiety symptoms (pre-post);
3.	Intervention will change the structural and functional connectivity in default mode and executive control networks; 
4.	Intervention will be associated with decreased inflammatory burden, and improved microbiome.
5.	MBCT intervention will be feasible and acceptable as indicated by sessions attendance, completion of home practices, recruitment and attrition rates, and participants’ MBCT group experiences assessed through focus groups and post MBCT evaluation questionnaire.

OBJECTIVES
Using 64 volunteer individuals (aged 16-29) with IBD and depression, the aim of this study is to conduct an RCT exploring the benefits of IBD-focused MBCT on depressive symptoms in youth living with IBD and comorbid depression. 

Secondary aims of this study are to explore the potential benefits of the MBCT on:
•	QoL, post-traumatic growth, medication adherence, health care empowerment, coping patterns, illness perceptions, and anxiety;
•	Biological markers of IBD,
•	Brain neuroconnectivity 
•	Specific aim related to the pilot nature of the study is to determine the feasibility of the program

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tatjana Ewais

Address

Mater Young Adult Health Centre
level 4, Salmon Building, Raymond Terrace, South Brisbane Qld 4101
t: 07 3163 5800, m: 0407208967

Country

Australia

Phone

+61731635800

Fax

+61731638445

t.ewais@uq.edu.au

Contact person for public queries

Name

Tatjana Ewais

Address

Mater Young Adult Health Centre level 4, Salmon Building, Raymond Terrace, South Brisbane Qld 4101 t: 07 3163 5800, m: 0407208967

Country

Australia

Phone

+61731635800

Fax

+61731635800

t.ewais@uq.edu.au

Contact person for scientific queries

Name

Tatjana Ewais

Address

Mater Young Adult Health Centre
level 4, Salmon Building, Raymond Terrace, South Brisbane Qld 4101
t: 07 3163 5800, m: 0407208967

Country

Australia

Phone

+61731635800

Fax

+61731635800

t.ewais@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification.

When will data be available (start and end dates)?

Beginning 3 months following main results publication, no end date determined.

Available to whom?

Case-by-case basis at the discretion of Primary Sponsor.

Available for what types of analyses?

To achieve the aims in the approved proposal, and for IPD meta-analyses.

How or where can data be obtained?

Data access will be subject to approvals by Principal Investigator, and signed data access agreement. Data will be made available by emailing the principal investigator Dr Tatjana Ewais at t.ewais@uq.edu.au.

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

Source	Title	Year of Publication	DOI
Embase	Mindfulness-based cognitive therapy experiences in youth with inflammatory bowel disease and depression: Findings from a mixed methods qualitative study.	2020	https://dx.doi.org/10.1136/bmjopen-2020-041140
Embase	Mindfulness based cognitive therapy for youth with inflammatory bowel disease and depression - Findings from a pilot randomised controlled trial.	2021	https://dx.doi.org/10.1016/j.jpsychores.2021.110594

N.B. These documents automatically identified may not have been verified by the study sponsor.

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