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Trial registered on ANZCTR


Registration number
ACTRN12619001699156
Ethics application status
Approved
Date submitted
28/11/2019
Date registered
3/12/2019
Date last updated
8/08/2022
Date data sharing statement initially provided
3/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation trial of Coeliac.Mindovergut.com: A brief psychological online resilience program for individuals living with coeliac disease and low-to-moderate psychological distress.
Scientific title
A non-randomised control validation trial of Coeliac.Mindovergut.com: A brief psychological online psychological transdiagnostic resilience program for individuals living with coeliac disease and low-to moderate psychological distress.
Secondary ID [1] 299949 0
Nil known
Universal Trial Number (UTN)
U1111-1244-5089
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Coeliac disease 315395 0
Psychological distress 315396 0
Condition category
Condition code
Oral and Gastrointestinal 313691 313691 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 313741 313741 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online Coeliac.Mindovergut.com intervention program is based on a combination of Stress Management (SM), CBT, and Acceptance and Commitment Therapy (ACT). SM strategies (such as relaxed breathing) will be utilised to reduce stress and the physiological impact that stress has on the body (e.g., increased muscle tension around the gastrointestinal tract). CBT strategies such as cognitive flexibility (identify and challenge unhelpful thinking patterns that promote stress and coeliac disease symptoms e.g., ‘My coeliac disease is getting worse’) and exposure work (a planned activity where individuals confront a situation which they currently avoid due to unwanted distress). ACT strategies (e.g., Mindfulness and cognitive defusion) aim to change the negative cycle of distress associated with illness.

A summary of the modules and their focus of target around coeliac-related processes are provide below:
Module 1: Stress management & moving towards your vision for the future – Stress management and setting goals based on your values; Targets: Hypervigilance/visceral sensitivity, perceived lack of control regarding coeliac disease, stress and psychological distress, and Identifying with illness
Module 2: How you think impacts on how you feel – Mindfulness and acceptance, and cognitive defusion; Targets: Catastrophizing and ruminating about symptoms, perceived lack of control regarding coeliac disease, hypervigilance/visceral sensitivity, and stress and psychological distress
Module 3: How you think impacts on how you feel - Cognitive flexibility; Targets: Catastrophizing and ruminating about symptoms, perceived lack of control regarding coeliac disease, hypervigilance/visceral sensitivity, and stress and psychological distress
Module 4: How you act can impact on how you think and feel - Exposure work; Targets: Avoidance, safely behaviours;
Module 5: Review and overcoming setbacks (OPTIONAL); Targets: Building gains, overcoming setbacks, other resources
Each of the modules will primarily consist of the principal investigator providing an oral commentary on module content. In addition, participants will be provided with handouts and audio files (relaxation tracks), see supplementary document for intervention content. All intervention content, including handouts and audio files were specifically developed for the Mindovergut resilience program.

Each module (1 per week) will take approximately 45 minutes to complete and homework activities taking around 20-40 minutes per day. All participants are offered to access module 5 after completing the postintervention questionnaire. Participants self-select if they wish to access the final module.
Intervention code [1] 316214 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322121 0
Psychological distress as assessed by Depression Anxiety and Stress Scale.
Timepoint [1] 322121 0
4 weeks after intervention commencement
Secondary outcome [1] 377425 0
Psychological distress as assessed by Depression Anxiety and Stress Scale.
Timepoint [1] 377425 0
4 weeks after intervention commencement

Eligibility
Key inclusion criteria
(1) Aged over aged 18 or older
(2) Have a diagnosis of coeliac disease by a medical professional (e.g., general practitioner,
gastroenterologist)
(3) Experience normal to moderate levels of psychological distress (as confirmed via the Mindovergut.com brief psychological distress assessment tool)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Currently seeing a mental health professional (e.g. psychologist, psychiatrist) for mental health concerns

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary statistical analyses will involve repeated measures multiple analysis of variance. Further quantitative analyses will be carried out with multivariate statistical models designed to allow for correlated repeated-measures data structures (e.g., generalized estimating equations and the subject specific generalized linear and latent mixed model).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
25/08/2020
Date of last participant enrolment
Anticipated
3/08/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
89
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 28669 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 304413 0
Other
Name [1] 304413 0
MindOverGut Psychological Services
Country [1] 304413 0
Australia
Funding source category [2] 304414 0
University
Name [2] 304414 0
Swinburne University of Technology
Country [2] 304414 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 304698 0
None
Name [1] 304698 0
Address [1] 304698 0
Country [1] 304698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304847 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 304847 0
Research Ethics, Integrity and Biosafety O??ce Swinburne Research (H68) PO Box 218 Hawthorn VIC 3122
Ethics committee country [1] 304847 0
Australia
Date submitted for ethics approval [1] 304847 0
29/11/2019
Approval date [1] 304847 0
20/03/2020
Ethics approval number [1] 304847 0
20202649-3981

Summary
Brief summary
The aim of the study is to explore the efficacy of the 4-week online Coeliac.Mindovergut.com resilience program for individuals living with coeliac disease and low to moderate psychological distress. The Coeliac.mindovergut.com resilience program is based on 5 modules (1 module per week), with the 5th module being optional. Each module (consisting of videos, text, handouts, and audio files e.g. relaxation tracks) is designed to be completed once a week, taking approximately 30 minutes, with
associated homework-based activities taking a further 20-40 minutes per day. It is hypothesised that participants will report reduced psychological distress and increased quality of life.
Trial website
Trial related presentations / publications
All presentations/summary findings relating to this trial will be published on the trial website:
www.Coeliac.Mindovergut.com.
Public notes

Contacts
Principal investigator
Name 98398 0
Dr Simon Knowles
Address 98398 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98398 0
Australia
Phone 98398 0
+61 392148206
Fax 98398 0
Email 98398 0
[email protected]
Contact person for public queries
Name 98399 0
Simon Knowles
Address 98399 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98399 0
Australia
Phone 98399 0
+61 392148206
Fax 98399 0
Email 98399 0
[email protected]
Contact person for scientific queries
Name 98400 0
Simon Knowles
Address 98400 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98400 0
Australia
Phone 98400 0
+61 392148206
Fax 98400 0
Email 98400 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
IPD will not be available. All publications will be based on grouped data to ensure individuals are not identifiable.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5936Informed consent form  [email protected]
5937Ethical approval  [email protected]



Results publications and other study-related documents

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