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Trial registered on ANZCTR


Registration number
ACTRN12619001698167p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2019
Date registered
3/12/2019
Date last updated
3/12/2019
Date data sharing statement initially provided
3/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation trial of Gastroparesis.Mindovergut.com: A brief psychological online resilience program for individuals living with gastroparesis and low-to-moderate psychological distress.
Scientific title
A non-randomised control validation trial of Gastroparesis.Mindovergut.com: A brief psychological online psychological transdiagnostic resilience program for individuals living with gastroparesis and low-to-moderate psychological distress.
Secondary ID [1] 299940 0
Nil known
Universal Trial Number (UTN)
U1111-1242-9048
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 315387 0
Psychological distress 315388 0
Condition category
Condition code
Oral and Gastrointestinal 313682 313682 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 313740 313740 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online Gastroparesis.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 gastroparesis symptoms e.g., ‘My gastroparesis 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 IBD-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 gastroparesis, 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 gastroparesis, 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 gastroparesis, 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] 316208 0
Treatment: Other
Intervention code [2] 316239 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322113 0
Psychological distress as assessed by Depression Anxiety and Stress Scale.
Timepoint [1] 322113 0
4 weeks after intervention commencement
Secondary outcome [1] 377378 0
Psychological distress as assessed by Depression Anxiety and Stress Scale.
Timepoint [1] 377378 0
4 weeks after intervention commencement

Eligibility
Key inclusion criteria
(1) Aged over aged 18 or older
(2) Have a diagnosis of gastroparesis 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
Gender
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
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 28663 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 304402 0
Other
Name [1] 304402 0
MindOverGut Psychological Services
Address [1] 304402 0
Dr Simon Knowles
C/O Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country [1] 304402 0
Australia
Funding source category [2] 304403 0
University
Name [2] 304403 0
Swinburne University of Technology
Address [2] 304403 0
John St, Hawthorn, Victoria, 3122 Australia
Country [2] 304403 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] 304697 0
None
Name [1] 304697 0
Address [1] 304697 0
Country [1] 304697 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304837 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 304837 0
Research Ethics, Integrity and Biosafety O??ce Swinburne Research (H68) PO Box 218 Hawthorn VIC 3122
Ethics committee country [1] 304837 0
Australia
Date submitted for ethics approval [1] 304837 0
29/11/2019
Approval date [1] 304837 0
Ethics approval number [1] 304837 0

Summary
Brief summary
The aim of the study is to explore the efficacy of the 4-week online Gastroparesis.Mindovergut.com resilience program for individuals living with gastroparesis and low to moderate psychological distress. The Gastroparesis.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
www.Gastroparesis.Mindovergut.com
Trial related presentations / publications
All presentations/summary findings relating to this trial will be published on the trial website:
www.IBD.mindovergut.com
Public notes

Contacts
Principal investigator
Name 98374 0
Dr Simon Knowles
Address 98374 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98374 0
Australia
Phone 98374 0
+61 392148206
Fax 98374 0
Email 98374 0
sknowles@swin.edu.au
Contact person for public queries
Name 98375 0
Dr Simon Knowles
Address 98375 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98375 0
Australia
Phone 98375 0
+61 392148206
Fax 98375 0
Email 98375 0
sknowles@swin.edu.au
Contact person for scientific queries
Name 98376 0
Dr Simon Knowles
Address 98376 0
Psychology Department (H24), Swinburne University of Technology, John St, Hawthorn, Victoria, 3122
Country 98376 0
Australia
Phone 98376 0
+61 392148206
Fax 98376 0
Email 98376 0
sknowles@swin.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
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?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5913 0
Informed consent form
Citation [1] 5913 0
Link [1] 5913 0
Email [1] 5913 0
sknowles@swin.edu.au
Other [1] 5913 0
Attachment [1] 5913 0
Type [2] 5914 0
Ethical approval
Citation [2] 5914 0
Link [2] 5914 0
Email [2] 5914 0
sknowles@swin.edu.au
Other [2] 5914 0
Attachment [2] 5914 0
Summary results
No Results