Skip to content

A validation trial of Gastroparesis.Mindovergut.com: A brief psychological online resilience program for individuals living with gastroparesis and low-to-moderate psychological distress.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001698167
Enrollment
9
Registered
2019-12-03
Start date
2020-08-25
Completion date
2025-07-23
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Swinburne University of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

Exclusion criteria

(1) Currently seeing a mental health professional (e.g. psychologist, psychiatrist) for mental health concerns.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026