Development and validation of a self-report general mental health scale for patients with functional gastroduodenal disorders

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.