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Trial registered on ANZCTR
Registration number
ACTRN12625001061426
Ethics application status
Approved
Date submitted
25/08/2025
Date registered
26/09/2025
Date last updated
26/09/2025
Date data sharing statement initially provided
26/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Wellbeing App for Functional Dyspepsia: A Pilot Study
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Scientific title
Evaluating the feasibility, acceptability and preliminary efficacy of a mobile cognitive behavioural therapy app for Functional Dyspepsia: a Pilot Randomised Controlled Trial
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Secondary ID [1]
315065
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Functional dyspepsia
338444
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Chronic indigestion
338742
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Condition category
Condition code
Oral and Gastrointestinal
334740
334740
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
CBT mobile app: This app intervention is a seven-module CBT program co-designed in collaboration with individuals living with FD and experienced clinicians. Based on CBT, the app covers psychoeducation, relaxation training, cognitive restructuring and behavioural experiments.
Each module includes 30 minutes of content delivered through videos, interactive activities and quizzes, designed for self-paced learning. This content is complemented by an additional 30 minutes of self-directed homework activities to reinforce and engage with the learned content.
The sequential unlocking of modules on a weekly basis is designed to ensure participants systematically engage with the CBT principles and gradually build their skills through the program. Participants are expected to complete one module per week for 7 weeks. Activities within each module can be done at any time during the week. To provide personalised support, address any questions and monitor adherence, a therapist will conduct brief phone calls with participants during weeks 4 and 6 of the intervention.
The intervention has been developed as a cross-platform app, allowing it to function on both Android and IOS operating systems. A connection to the internet or data is required to stream the videos in the app. The app is free to download. The number of activities completed will be collected via the app to assess adherence to the intervention.
The seven modules included in the CBT-FD app are as follows:
Module 1: The gut-brain connection
The first module acknowledges that individuals experiencing persistent FD symptoms may be frustrated and struggling with the unknown nature of the symptoms. The module introduces the gut-brain connection and its role in perpetuating FD symptoms. Participants will learn about symptom tracking and complete a symptom diary for the week.
Module 2: Stress and the gut
The second module dives into stress and its impact on digestive wellbeing, particularly FD symptoms. To support symptom management, this module introduces three brief relaxation techniques (deep breathing, progressive muscle relaxation and guided imagery). Participants will be asked to practice at least one of the techniques consistently throughout the week.
Module 3: Automatic thoughts
The third module introduces the gastrointestinal-focused cognitive behavioural model in the context of FD, with examples. The second half of this module focuses on automatic thoughts and how to identify unhelpful ones. Participants will keep a thought diary throughout the week.
Module 4: Alternative thoughts
The fourth module covers ways to challenge unhelpful automatic thoughts to generate more helpful alternative thoughts. Participants will keep a thought diary throughout the week with additional thought-challenging prompts.
Module 5: Coping skills
The fifth module introduces problem vs emotion-focused coping. The rest of the module focuses on the vicious cycle of behaviours and symptoms and how to start scheduling back pleasant activities into their routine. Participants will schedule at least three pleasant activities for the upcoming week.
Module 6: Behavioural experiments
The sixth module introduces the feedback fear cycle. The rest of the module teaches different behavioural experiments, including hypothesis testing and exposure exercises. Participants will complete one of each experiment throughout the week.
Module 7: Bringing it home
The final module provides a summary of the learnings and provides prompts to create a personalised action plan for the future. Participants will create an action plan for the future.
Onboarding
Participants allocated to the app condition will go through a comprehensive onboarding with a member of the research team. This process will involve participants setting up their accounts and going through the first exercise together. For those who have already done a BSGM test within the last 6 months and had no changes to symptom management, they will do their onboarding session online.
Account creation
When participants open the app for the first time, they will be presented with a splash screen with a welcome message and prompts for basic demographic information used for personalisation. Users will then be required to create a secure account, allowing data storage and secure login/logout.
Videos
Each module incorporates at least one embedded portrait video providing accessible visual and auditory explanations of the module’s content. An internet or data connection is required to stream the video content within the app. These videos can be accessed and revisited under the ‘modules’ tab.
Activities
Each module offers three or more interactive activities designed to actively engage users with the content covered in the videos. For example, a matching game with cognitive distortions and thoughts or a choose-your-own-adventure style activity for learning about the cognitive behavioural model in an FD context.
Symptom tracking
A dedicated ‘symptom tracking’ section, accessible via the navigation bar, allows users to log their daily stomach and mental health symptoms. After a week of consistent logging, a ‘weekly insights’ feature will unlock, displaying potential correlations between mood and stomach symptoms. This section also integrates a thought diary (linked to modules 3 and 4) and an activity calendar (linked to module 5), serving as a centralised tool for logging symptoms, mood and activities relevant to weekly exercises.
Flare-up toolkit
A ‘flare-up toolkit’ is readily accessible via the navigation bar. This feature is designed to provide users with immediate, in-the-moment support strategies for managing acute symptom flare-ups, and may include exercises such as deep breathing or guided imagery.
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Intervention code [1]
331676
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Behaviour
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Comparator / control treatment
There are two control arms in this study (one that receives Zoom CBT and a waitlist control).
Zoom CBT: The CBT intervention will be delivered over Zoom videoconferencing software by a teletherapist, a master's level trainee health psychologist. Each week (for 7 weeks), participants will have a 30-minute session with the teletherapist and will be asked to complete an additional 30 minutes of online homework or practice exercises in their own time. The intervention content is the same as described above in the app intervention. The teletherapist will refer to an on-screen script to ensure the intervention content is consistent across CBT groups and participants. The teletherapist will be trained and supervised by a senior health psychologist specialised in gastropsychology.
CBT delivered via Zoom was chosen as an active control group to isolate the effects of the app delivery method, keeping the tailored content the same. In-person CBT has comparable effects to telehealth CBT, and telehealth was selected to reduce patient burden and allow them to complete at home and overseas (Stubbings et al., 2013; Zandieh et al., 2024). Adherence to this condition will be monitored by an attendance checklist.
Waitlist control (reference comparator arm): Following the initial visit, participants will be asked to continue their standard of care and complete follow-up questionnaires simultaneously with the CBT groups. Participants will be emailed to remind participants and prevent drop out. Participants will be offered access to the mobile app after completing their 16-week follow-up questionnaire.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility - Engagement
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Assessment method [1]
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To assess the feasibility of our interventions, we will define 'adequate engagement' for the CBT app group and Zoom CBT group as follows (Bryan et al., 2012): CBT App Group: Adequate engagement will be defined as the completion of at least 5 out of 7 modules within the 7-week intervention period, combined with completion of at least 75% of the associated interactive activities and homework exercises for the completed modules. This will be determined from app analytics. Participants will also be encouraged to use the symptom tracking feature, and consistent logging (e.g., 4 days/week on average) will be noted as a second measure of engagement. Completion of the week 4 and 6 therapist check-in calls will be the third measure of engagement. Zoom CBT Group: Adequate engagement will be defined as the attendance at a minimum of 5 out of 7 scheduled 30-minute weekly Zoom sessions with the teletherapist, combined with the completion of at least 75% of the assigned online homework/practice exercises.
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Timepoint [1]
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Immediately after the 7-week intervention period.
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Primary outcome [2]
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Feasibility - Trial methods
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Assessment method [2]
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This is a composite outcome designed to assess the feasibility of the trial methods. It is comprised of the following components: Recruitment and pathway rates: The number and proportion of participants recruited via each specified pathway (e.g., clinic referral, social media advertisement, etc.) via study logs. Missing data: The proportion of missing data for primary and secondary outcome measures. Issues with questionnaire completion: The rate and nature of completion issues for the participant questionnaires, as determined by Qualtrics Analytics (e.g., page drop-off rates, time to completion). Methodological challenges: A summary of procedural or methodological challenges encountered during the trial.
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Timepoint [2]
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Recruitment rate/pathways - Assessed at the completion of the planned recruitment period for the study. Missing data - Assessed after the final participant has completed their final follow-up visit Questionnaire completion - Assessed upon completion of the data collection period for the entire study cohort. Methodological challenges: Documented on an ongoing basis in study logs and formally summarised at the end of the study as reported by researchers.
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Primary outcome [3]
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Acceptability
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Assessment method [3]
342391
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User Mobile Application Rating Scale (uMARS) is a 20-item scale that contains four objective subscales assessing engagement, functionality, aesthetics and information quality, and one subjective quality subscale.
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Timepoint [3]
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Immediately after the 7-week intervention period.
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Secondary outcome [1]
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Acceptability (qualitative)
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Assessment method [1]
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Qualitative questions will be asked at the end of the post-intervention questionnaire to give participants a chance to provide detailed feedback or suggest improvements to the app or Zoom therapy, including: What did you like most about the app/Zoom therapy? What did you like least about the app/Zoom therapy? What motivated you to use or demotivated you from using the app/Zoom therapy? What changes would you suggest to improve the app/Zoom therapy? Did you find the content of the app/Zoom therapy helpful? Why or why not? Would you recommend the app/Zoom therapy to others with functional dyspepsia? Why or why not? Do you have any other comments or feedback?
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Timepoint [1]
450656
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Immediately after the 7-week intervention period.
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Secondary outcome [2]
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Symptoms
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Assessment method [2]
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The Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) questionnaire assesses upper GI symptoms. This is a 20-item scale that has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain and lower abdominal pain. Patients are asked to rate the severity of different symptoms during the past two weeks on a 6-point Likert scale, including 0, none; 1, very mild; 2, mild; 3, moderate; 4, severe and 5, very severe.
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Timepoint [2]
450657
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention
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Secondary outcome [3]
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Quality of life
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Assessment method [3]
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The Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QOL) questionnaire assesses the quality of life in patients with upper GI disorders. This is a 30-item scale that covers five domains: daily activities, clothing, diet and food habits, relationship, psychological wellbeing and distress. Patients are asked to rate how the GI problems they experience affect different domains of their quality of life and wellbeing during the past two weeks on a 6-point Likert scale, including 0, none of the time; 1, a little of the time; 2, some of the time; 3, a good bit of the time; 4, most of the time and 5, all of the time.
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Timepoint [3]
450658
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention
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Secondary outcome [4]
450659
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Depression
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Assessment method [4]
450659
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The Patient Health Questionnaire Depression Scale (PHQ-8) is a self-reported questionnaire that helps assess the severity of depression. This is an 8-item scale that asks patients to rate how often they have been bothered by different problems during the past two weeks on a 4-point Likert scale, including 0, not at all; 1, several days; 2, more than half the days; 3, nearly every day. A score of 10 or greater is considered major depression, 20 or more is severe major depression (Kroenke et al., 2009).
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Timepoint [4]
450659
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Secondary outcome [5]
450660
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Anxiety
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Assessment method [5]
450660
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The Generalised Anxiety Disorder-7 (GAD-7) scale measures the severity of anxiety based on how often patients experience different symptoms of anxiety. Items are rated on a 4-point Likert scale, including 0, not at all; 1 several days; 2 more than half the days; and 3, nearly every day. Items are combined to give a total score. Scores of 5, 10 and 15 represent the cutoffs for mild, moderate and severe anxiety, respectively (Spitzer et al., 2006).
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Timepoint [5]
450660
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Secondary outcome [6]
450661
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Stress
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Assessment method [6]
450661
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The Perceived Stress Scale (PSS-4) measures individual stress levels. This is a 4-item scale that asks people about their thoughts and feelings over the last month on a 5-point Likert scale, including 0, never; 1, almost never; 2, sometimes; 3, fairly often, and 4, very often. Total scores range from 0 to 16, with higher scores indicating higher levels of perceived stress.
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Timepoint [6]
450661
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Secondary outcome [7]
450662
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Mental health
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Assessment method [7]
450662
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The Alimetry Gut Brain Wellbeing (AGBW) survey assesses mental health in patients with chronic gastroduodenal symptoms. This is a 10-item scale that covers three dimensions: depression, stress and anxiety, with an optional open-ended question. Patients are asked about their mental wellbeing over the past two weeks on a 5-point Likert scale, including 0, none of the time; 1, a little of the time; 2, some of the time; 3, most of the time; and 4, all of the time.
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Timepoint [7]
450662
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Secondary outcome [8]
450663
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Gastrointestinal symptom-specific anxiety
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Assessment method [8]
450663
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The Visceral Sensitivity Index (VSI) measures gastrointestinal symptom-specific anxiety in patients with DGBIs. This is an unidimensional 15-item scale that gives statements that describe how some people respond to symptoms or discomfort in their belly or lower abdomen. People are asked to answer ‘how strongly you agree or disagree’ with each of these statements, as they relate to them on a 6-point Likert scale, including 1, strongly agree; 2, moderately agree; 3, mildly agree; 4, mildly disagree; 5, moderately disagree; 6, strongly disagree. Total scores range from 0 to 75, with higher scores indicating more severe symptom-related anxiety.
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Timepoint [8]
450663
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Secondary outcome [9]
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Illness perceptions
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Assessment method [9]
450664
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The Revised Brief Illness Perception Questionnaire (BIPQ-R) assesses the cognitive and emotional representations of illness. This is a 9-item scale that covers perceived consequences, timeline, perceived personal control, treatment control, identity, concern and coherence of the illness, and emotional representation. There is one question rated on a scale of 0 to 10 for each dimension. Higher scores show stronger perceptions in that dimension. The BIPQ has demonstrated good test-retest reliability, and concurrent, predictive and discriminant validity (Broadbent et al., 2006). The BIPQ has been revised, whereby ‘illness’ from the original questionnaire was replaced with ‘gastrointestinal symptoms’ for study relevance, as advised by the authors.
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Timepoint [9]
450664
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Baseline, immediately after the 7-week intervention period, and 8 weeks after finishing the intervention.
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Eligibility
Key inclusion criteria
Patients are 18 years of age or older
Patients have a self-reported clinical diagnosis of functional dyspepsia and/or meet the ROME-IV diagnostic criteria.
Patients can give informed consent to undergo a baseline BSGM recording, participate in the allocated intervention group, and complete all study questionnaires at baseline and follow-up time points.
Patients have a mobile phone and/or computer with internet access.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who are pregnant or lactating.
Patients with a history of skin allergies or extreme sensitivity to cosmetics or lotions.
Patients with fragile skin, evidenced by high susceptibility to skin tears or skin that bruises and breaks easily.
Patients with open abdominal wounds or abdominal skin not intact (e.g. rash, abrasions, weeping tissues).
Patients who are unable to remain in a relaxed, reclined position for the test duration.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocations will be concealed in sealed opaque envelopes from the researcher who enrols participants until after participants have enrolled and consented to participate.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly allocated to 1 of 3 conditions using a 1:1:1 allocation ratio. Randomisation will be done using Research Randomiser software by a researcher not involved in data collection.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
1/10/2026
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Actual
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Date of last data collection
Anticipated
1/06/2027
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
319633
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Government body
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Name [1]
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Health Research Council
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Address [1]
319633
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Country [1]
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New Zealand
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Primary sponsor type
Government body
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Name
Health Research Council (HRC)
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Address
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Country
New Zealand
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Secondary sponsor category [1]
322136
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None
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Name [1]
322136
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Address [1]
322136
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Country [1]
322136
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Other collaborator category [1]
283616
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Commercial sector/Industry
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Name [1]
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Alimetry Ltd.
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Address [1]
283616
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Country [1]
283616
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318193
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
318193
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
318193
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New Zealand
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Date submitted for ethics approval [1]
318193
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05/06/2025
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Approval date [1]
318193
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01/08/2025
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Ethics approval number [1]
318193
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2025 EXP 23024
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Summary
Brief summary
This pilot study is designed to evaluate a new co-designed mobile app that delivers cognitive behavioural therapy (CBT) for people with functional dyspepsia (FD), a common upper gastrointestinal disorder. The study will explore whether the app is easy to use, liked by patients, and if it helps to reduce symptoms and improve quality of life. Participants will be randomly assigned to one of three groups: 1) Mobile CBT App for 7 weeks, 2) Zoom CBT for 7 weeks, or 3) Waitlist Control (care as usual) for 7 weeks. Researchers will collect data on adherence to the app, how often participants use the app, and their feedback on using it. They will also measure changes in symptoms, quality of life, and mental health using questionnaires. Additionally, participants will undergo a baseline body surface gastric mapping test to explore if different stomach patterns affect how they respond to the CBT interventions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
143406
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Prof Elizabeth Broadbent
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Address
143406
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The University of Auckland, Surgery Department, 507 Park Road, Grafton, Auckland
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Country
143406
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New Zealand
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Phone
143406
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+64 0211227977
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Isabella Pickering
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Address
143407
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The University of Auckland, Surgery Department, 507 Park Road, Grafton, Auckland
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Country
143407
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New Zealand
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Phone
143407
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+64 0220372896
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Fax
143407
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Email
143407
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[email protected]
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Contact person for scientific queries
Name
143408
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Isabella Pickering
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Address
143408
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The University of Auckland, Surgery Department, 507 Park Road, Grafton, Auckland
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Country
143408
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New Zealand
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Phone
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+64 0220372896
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Fax
143408
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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