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Trial registered on ANZCTR


Registration number
ACTRN12623000385640
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
17/04/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
17/04/2023
Date results provided
17/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and validation of a self-report general mental health scale for patients with functional gastroduodenal disorders
Scientific title
Development and validation of a self-report general mental health scale for patients with gastroduodenal disorders of gut-brain interaction
Secondary ID [1] 309321 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional gastroduodenal disorders 329512 0
Condition category
Condition code
Oral and Gastrointestinal 326447 326447 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will distribute an anonymous, cross-sectional survey to patients with functional gastroduodenal disorders (FGDDs), to assess the validity and reliability of a new self-report general mental health scale for patients with FGDDs.

The survey will be completely anonymous, and no identifying information will be collected from the patients. This survey is hosted on Qualtrics and should take approximately 15-20 minutes and will be completed entirely online. The survey will start by explaining the purpose of the study, and a link to the participant information sheet will be provided in case they want more detail about the study. They will then be asked to provide informed consent, by reading a set of consent clauses and checking a box to indicate their consent.

After providing informed consent, patients will first be provided with questions pertaining to the eligibility criteria, including asking their age, their ability to read and write English fluently, if they are a vulnerable member of the community, and whether they have a diagnosis of a FGDD or meet the Rome IV symptom criteria for a FGDD. If they do not meet the eligibility criteria, the survey will conclude. If they do meet the eligibility criteria, they will then be provided with a short demographics questionnaire. Participants will be asked to provide some basic demographics including their age, gender, ethnicity, education level, relationship status, and country of residence. They will also be asked if they have ever been diagnosed with a mental health issue or are currently receiving treatment (including medications and therapy) for a mental health issue.

After which, they will be presented with a battery of psychological questionnaires, which includes the newly developed scale. These questionnaires will be presented in a randomised order to avoid the possibility of order effects. The following psychological questionnaires will be measured to assess convergent validity: the PHQ-9 to measure depression, the GAD-7 to measure generalised anxiety, the PSS-4 to measure chronic stress, the Depression Anxiety and Stress Scale 21 (DASS-21) to measure anxiety, depression, and stress in an integrated scale, and the Kessler Psychological Distress Scale (K-10) to measure total levels of distress and mental health.

The newly developed scale is an optimised scale that measures general mental health, developed for use as a screening tool in patients with FGDDs. It consists of 10-questions, which ask patients to rate how often they have felt or behaved in a certain way over the last two weeks on a scale of 0 (none of the time) to 5 (all of the time). The scores from each individual question can be totaled to create a total mental health score. Three subscales can also be calculated; a depression subscale score, a stress subscale score, and an anxiety subscale score.

The Big Five Inventory (BFI) extraversion subscale which measures levels of extraversion/introversion and the Emotion Regulation Questionnaire (ERQ) which measures emotion regulation, will be used to assess divergent validity. Lastly, concurrent validity will be assessed using the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) which measures quality of life in patients with DGBIs.

At the end of the survey, participants will have the option to enter a prize draw to win one of 10 e-vouchers worth the equivalent of $50NZD (this will be converted to the participants' local currency) as a thank you for their time.
Intervention code [1] 325755 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334302 0
Internal consistency reliability of the new scale's total score and subscale scores, as measured by Cronbach's alpha
Timepoint [1] 334302 0
At the completion of the study
Primary outcome [2] 334303 0
Convergent validity of the new scales' total score and the depression subscale score, as measured by Pearson's correlations with the Patient Health Questionnaire 9 (PHQ-9)
Timepoint [2] 334303 0
At the completion of the study
Secondary outcome [1] 420193 0
(Primary) Concurrent validity of the new scales; total score as measured by Pearson's correlations with the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL)
Timepoint [1] 420193 0
At the completion of the study
Secondary outcome [2] 420194 0
(Primary) Known Groups Validity of the new scale's total score and subscale scores as measured by independent samples t-tests between males and females
Timepoint [2] 420194 0
At the completion of the study
Secondary outcome [3] 420492 0
(Primary) Convergent validity of the new scales' total score and anxiety subscale score, as measured by Pearson's correlations with the Generalised Anxiety Disorder 7 (GAD-7)
Timepoint [3] 420492 0
At the completion of the study
Secondary outcome [4] 420493 0
(Primary) Convergent validity of the new scales' total score and stress subscale score, as measured by Pearson's correlations with the Perceived Stress Scale 4 (PSS-4)
Timepoint [4] 420493 0
At the completion of the study
Secondary outcome [5] 420494 0
(Primary) Convergent validity of the new scales' total score and subscale scores, as measured by Pearson's correlations with the Depression Anxiety and Stress Scale 21 (DASS-21)
Timepoint [5] 420494 0
At the completion of the study
Secondary outcome [6] 420495 0
(Primary) Convergent validity of the new scales' total score and subscale scores, as measured by Pearson's correlations with the Kessler Psychological Distress Scale (K-10).
Timepoint [6] 420495 0
At the completion of the study
Secondary outcome [7] 420496 0
(Primary) Divergent validity of the new scale's total score and subscale scores, as measured by Pearson's correlations with the Big Five Inventory (BFI) extraversion subscale
Timepoint [7] 420496 0
At the completion of the study
Secondary outcome [8] 420497 0
(Primary) Divergent validity of the new scale total score and subscale scores, as measured by Pearson's correlations with the Emotion Regulation Questionnaire (ERQ).
Timepoint [8] 420497 0
At the completion of the study
Secondary outcome [9] 420498 0
(Primary) Known Groups Validity of the new scale's total score and subscale scores as measured by independent samples t-tests between those patients with and without a previous mental health diagnosis.
Timepoint [9] 420498 0
At the completion of the study

Eligibility
Key inclusion criteria
Patients will be included if they are over the age of 18, able to speak, read, and write fluently in English, and meet the diagnostic criteria for a functional gastroduodenal disorder (as defined by the Rome IV criteria). These conditions include: gastroparesis, functional dyspepsia, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, rumination syndrome, cannabinoid hyperemesis syndrome, or a belching disorder. Patients will be included if they meet the Rome IV criteria for at least one of the conditions based on their reported gastroduodenal symptoms, or if they have previously been diagnosed with at least one functional gastroduodenal disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Vulnerable participants (e.g. prisoners, individuals with a known cognitive impairment or institutionalised individuals) and patients with self-induced vomiting or an eating disorder will be excluded from this study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Demographic analyses will be conducted to describe the sample. Targeted recruitment may be undertaken to ensure the sample is representative of the DGBI community.

The descriptives of the new scale will then be explored to examine response distributions. This will include calculating the means, standard deviations, normality (kurtosis and skewness), and outliers for the total score, the subscale scores, and for each individual question. If non-normal distributions are found, non-parametric versions of the below tests will be used.

Internal Consistency Reliability: To measure internal consistency reliability, Cronbach’s alpha and item-total correlations will be calculated to examine internal consistency reliability of the individual subscales and total score of the scale. An alpha coefficient above 0.70 indicates acceptable internal consistency reliability, with an alpha above 0.80 being preferred for psychometric scales.

Convergent Validity: Convergent validity will be measured by Pearson's correlation coefficients. Although there is no exact rule, an r>0.5 (large effect size) between the new scale and the existing mental health scales is generally considered sufficient to suggest good convergent validity. While an r>0.3 (medium effect size) is acceptable to show adequate convergent validity.

Divergent Validity: Divergent validity is traditionally measured by Pearson's correlation coefficients. There is no exact criteria for the value of correlations needed for divergent validity. However, to show divergent validity, these correlation coefficients must be weaker than the correlations with the scales used for convergent validity.

Concurrent Validity: Concurrent validity is traditionally measured by Pearson's correlation coefficients. To show adequate concurrent validity, the correlation coefficients should be in the predicted direction and be statistically significant. Correlation coefficients of r>0.5 are considered strong correlations, r=0.3-0.5 moderate correlations, and r<0.3 weak correlations.

Known Groups Validity: Known groups validity is traditionally measured by independent samples t-tests between groups that theoretically should have different scores on the scale. It is expected based on previous research, that females will have higher average scores, compared to males. It is also expected that patients with a previous mental health diagnosis will have higher average scores on the scale compared to patients who have not had a previous mental health diagnosis. Significant differences, in the predicted direction, in these t-tests will provide evidence for known groups validity.

After doing the analyses for the sample as a whole, the analyses will then be repeated to compare two subgroups: those aged 18-20 and those aged 21+. This will be done to assess whether there is a difference in the validity of the scale for those aged under 21 that may need to be accounted for.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
17/04/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
16/08/2023
Date of last data collection
Anticipated
31/12/2023
Actual
16/08/2023
Sample size
Target
300
Accrual to date
Final
311
Recruitment outside Australia
Country [1] 25358 0
New Zealand
State/province [1] 25358 0
Auckland

Funding & Sponsors
Funding source category [1] 313517 0
Government body
Name [1] 313517 0
New Zealand Health Research Council
Country [1] 313517 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315302 0
None
Name [1] 315302 0
Address [1] 315302 0
Country [1] 315302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312704 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 312704 0
Ethics committee country [1] 312704 0
New Zealand
Date submitted for ethics approval [1] 312704 0
13/03/2023
Approval date [1] 312704 0
12/04/2023
Ethics approval number [1] 312704 0

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

Contacts
Principal investigator
Name 125614 0
Prof Greg O'Grady
Address 125614 0
The University of Auckland, 86 Symonds Street, Grafton, Auckland 1010
Country 125614 0
New Zealand
Phone 125614 0
+64 9 870 8178
Fax 125614 0
Email 125614 0
[email protected]
Contact person for public queries
Name 125615 0
Mikaela Law
Address 125615 0
The University of Auckland, 86 Symonds Street, Grafton, Auckland 1010
Country 125615 0
New Zealand
Phone 125615 0
+64 9 870 8178
Fax 125615 0
Email 125615 0
[email protected]
Contact person for scientific queries
Name 125616 0
Mikaela Law
Address 125616 0
The University of Auckland, 86 Symonds Street, Grafton, Auckland 1010
Country 125616 0
New Zealand
Phone 125616 0
+64 9 870 8178
Fax 125616 0
Email 125616 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
All data is anonymous and presented as aggregate statistics. IPD will not be available in order to assure confidentiality for our participants. This is a condition of our ethical approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18733Study protocol  [email protected]
18734Statistical analysis plan  [email protected]
18735Informed consent form  [email protected]
18736Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.