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Trial registered on ANZCTR


Registration number
ACTRN12624001382561p
Ethics application status
Not yet submitted
Date submitted
7/11/2024
Date registered
21/11/2024
Date last updated
21/11/2024
Date data sharing statement initially provided
21/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation trial of the Mindovergut.com optimal health and resilience program for adults living with a gastrointestinal condition and low-to-moderate psychological distress
Scientific title
A non-randomised control validation trial of Mindovergut.com: A brief psychological online psychological transdiagnostic resilience program for individuals living with a gastrointestinal condition and low-to-moderate psychological distress.
Secondary ID [1] 313325 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal condition 335679 0
Psychological distress 335752 0
Condition category
Condition code
Oral and Gastrointestinal 332240 332240 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 332241 332241 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 online Mindovergut.com resilience 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 gastrointestinal symptoms e.g., ‘My gastrointestinal 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.

The Mindovergut.com resilience program consists of 7 modules, each targeting a specific set of areas and factors known to exacerbate or maintain gastrointestinal difficulties and associated psychological distress. The modules are designed in a step-like fashion, with each Module building upon the strategies that have been learnt previously. What this means is that as participants progress through the Program, the workload will increase as they continue to practice things already learnt, whilst also incorporating new skills and activities into the daily routine. However, with practice it is hoped that many of the exercises engaged with will become second nature, requiring less effort and energy as they become more familiar and effective. Importantly, participants are also recommended throughout the program to pace the work they undertake in a way that best suits them and their situation.

Each module (1 per week) will take approximately 30 minutes to complete and homework activities taking around 20-40 minutes per day. The modules will include a combination of videos, text, handouts, and audio files (e.g. relaxation tracks).

A summary of the modules and their focus of target around gastrointestinal-related processes are provided below:

Introduction to the program: Provides an overview of the program including its structure aims, and time requirements. The introduction also outlines the psychosocial processes associated with optimal health and resilience for those living with a gastrointestinal condition, and in turn how they are the target of the intervention. Finally, information about the psychological strategies what form the basis for the transdiagnostic program is outlined.

Module One, entitled “Promoting a Growth Mindset”, lays the foundation for the many skills and strategies participants will learn as part of this Program overall. Too often, resilience and optimal health is blocked by negative thinking. As part of this Module, participants will therefore learn how to develop a positive growth mindset and get their mind to start reorienting itself towards positive aspects of life and experiences and acknowledging them, even during times of physical and/or psychological distress. Importantly, this module will also talk about and ask participants to identify potential barriers to taking part in and completing this program. The practice activities will be to complete Handout 1.1 (Building a growth mindset and cultivating gratitude) and engage in 1 to 2 minutes each day completing a gratitude diary.

Module Two, entitled “Moving Towards Your Vision for the Future”, is focused on identifying values-based goals to help participants move towards the life they want to live. A key aspect of building resilience and optimal health is to identify and engage in those activities in life that give meaning, that is, values. The practice activities will include the gratitude diary and completing Handout: 2.1 (Identifying a vision for the future consistent with your values).

Module Three, entitled “Stress Management”, targets stress and psychological distress. As part of this Module, participants will learn how to not only reduce overall stress levels but also how to use slow, relaxed breathing to help calm the body during peak levels of distress. The practice activities will include the gratitude diary, engaging in slow relaxed breathing, and completing Handout: 3.1 (Relaxation diary).

Module Four, entitled “How You Think Impacts How You Feel: Mindfulness, Acceptance and Cognitive Defusion” targets catastrophising and rumination about symptoms. This Module explores the role of emotions and thoughts, and how by being observant of one’s experiences, rather than getting caught up in them, participants can break the negative cycle of thoughts, feelings, and emotions which perpetuates distress. The practice activities will include the gratitude diary, engaging in slow relaxed breathing, and completing Handout: 3.1 (Relaxation diary), and engage in cognitive defusion strategies as described in Handout 4.4.

Module Five, entitled “How You Think Impacts How You Feel: Cognitive Flexibility,” targets similar processes to Module 3 but is aimed at building cognitive flexibility. In other words, this Module helps participants identify and challenge the thoughts that facilitate distress and poor symptom management. The practice activities will include the gratitude diary, engaging in slow relaxed breathing, and completing Handout: 3.1 (Relaxation diary), and engage in cognitive defusion strategies as described in Handout 4.4, engage in and practice cognitive flexibility (Handout 5.2) and use the worry diary (Handout 5.3).

Module Six, entitled “How You Act Can Impact How You Think and Feel: Exposure Work”, targets avoidance and safety behaviours, helping participants confront fears through planning and engaging with exposure work. The practice activities will include the gratitude diary, engaging in slow relaxed breathing, and completing Handout: 3.1 (Relaxation diary), and engage in cognitive defusion strategies as described in Handout 4.4, engage in and practice cognitive flexibility (Handout 5.2), use the worry diary (Handout 5.3), develop a exposure activity plan (Handout 6.1).

Lastly, Module Seven, the final Module, is entitled “Reviewing and Overcoming Setbacks” and is aimed at consolidating all that has been learnt in the previous six Modules. This Module will help participants identify strategies which might be used to overcome future setbacks and challenges and provides other resources which may be found helpful on the journey towards optimal health and resilience.

Monitoring of adherence to the intervention (including practice activities) will be attained by participants completing a self-report online questionnaire prior to starting the next module.
Intervention code [1] 329905 0
Treatment: Other
Intervention code [2] 329906 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339817 0
Quality of life
Timepoint [1] 339817 0
Baseline and 8 weeks later.
Secondary outcome [1] 441503 0
Depression
Timepoint [1] 441503 0
Baseline and 8 weeks later.
Secondary outcome [2] 441770 0
Stress
Timepoint [2] 441770 0
Baseline and 8 weeks later.
Secondary outcome [3] 441771 0
Anxiety
Timepoint [3] 441771 0
Baseline and 8 weeks later

Eligibility
Key inclusion criteria
(1) Aged over aged 18 or older
(2) Have a diagnosis of a gastrointestinal condition 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)
(4) Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
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
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2025
Actual
Date of last participant enrolment
Anticipated
27/12/2029
Actual
Date of last data collection
Anticipated
28/02/2030
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26684 0
New Zealand
State/province [1] 26684 0
Country [2] 26685 0
United Kingdom
State/province [2] 26685 0
Country [3] 26686 0
Canada
State/province [3] 26686 0
Country [4] 26687 0
United States of America
State/province [4] 26687 0

Funding & Sponsors
Funding source category [1] 317777 0
Other
Name [1] 317777 0
Mindovergut Psychological Services
Country [1] 317777 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 320092 0
None
Name [1] 320092 0
Address [1] 320092 0
Country [1] 320092 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316462 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316462 0
https://www.swinburne.edu.au/research/ethics/human-research/
Ethics committee country [1] 316462 0
Australia
Date submitted for ethics approval [1] 316462 0
20/12/2024
Approval date [1] 316462 0
Ethics approval number [1] 316462 0

Summary
Brief summary
The aim of the study is to explore the efficacy of the 7-week online Mindovergut.com optimal health and resilience program for individuals living with a gastrointestinal condition and low to moderate psychological distress. The Mindovergut.com resilience program is based on 7 modules (1 module per week). 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 increased quality of life post intervention.
Trial website
www.mindovergut.com
Trial related presentations / publications
Public notes
All presentations/summary findings relating to this trial will be published on the trial website:
www.mindovergut.com

Contacts
Principal investigator
Name 137966 0
A/Prof Simon Knowles
Address 137966 0
Department of Psychology (H24), Swinburne University of Technology, John Street, Hawthorn, Victoria, 3122.
Country 137966 0
Australia
Phone 137966 0
+61392148206
Fax 137966 0
Email 137966 0
[email protected]
Contact person for public queries
Name 137967 0
Simon Knowles
Address 137967 0
Department of Psychology (H24), Swinburne University of Technology, John Street, Hawthorn, Victoria, 3122.
Country 137967 0
Australia
Phone 137967 0
+61392148206
Fax 137967 0
Email 137967 0
[email protected]
Contact person for scientific queries
Name 137968 0
Simon Knowles
Address 137968 0
Department of Psychology (H24), Swinburne University of Technology, John Street, Hawthorn, Victoria, 3122.
Country 137968 0
Australia
Phone 137968 0
+61392148206
Fax 137968 0
Email 137968 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.


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.