Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510296
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMBI
Brief Summary:
The bidirectional effects between psychological distress and inflammatory bowel disease IBD activity mean that not only does increased IBD activity trigger psychological distress but psychological distress triggers increased IBD activity ie gut-brain interaction Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life HRQoL This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing The IBD Social Cognitive Model IBD SCM posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD access and scalability of this form of support is not yet widespread particularly in resource-limited settings Though many people with IBD have significant psychological distress mental health care is underutilized with cost cited as a barrier
The emergence of digital interventions in clinical practice presents an opportunity to address access scalability and cost barriers However current testing of digital interventions to address gut-brain interactions digital mind-body intervention DMBI among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits Individuals with limited resources and those from racial and ethnic minority groups eg Black Hispanic often have socioecological factors such as healthcare access and mental health stigma that impede their use of psycho-behavioral resources DMBI development informed by participatory research approaches are therefore critical to facilitate equitable engagement and utilization Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance mindfulness and values-based approaches
Although high quality evidence demonstrates psychological improvement with DMBI in IBD feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking
The emergence of digital interventions in clinical practice presents an opportunity to address access scalability and cost barriers However current testing of digital interventions to address gut-brain interactions digital mind-body intervention DMBI among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits Individuals with limited resources and those from racial and ethnic minority groups eg Black Hispanic often have socioecological factors such as healthcare access and mental health stigma that impede their use of psycho-behavioral resources DMBI development informed by participatory research approaches are therefore critical to facilitate equitable engagement and utilization Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance mindfulness and values-based approaches
Although high quality evidence demonstrates psychological improvement with DMBI in IBD feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking
Detailed Description:
Prior to conducting the randomized pilot study as part of Aim 1 patient focus groups will be conducted based on the IBD social-cognitive model IBD SCM with a prototype DMBI to assess resonance and preferences on how to convey and display intervention concepts and components Semi-structured interviews will be conducted among gastroenterology professionals GIs to assess perceived needs and barriers to DMBI acceptance and use in clinical care of Black and Hispanic patients with IBD and define intervention elements
Aim 2 will be guided by the needsbarriers identified in Aim 1 a functional DMBI app will be developed A formativesummative evaluation of the app intervention will be conducted through iterative patient user testing to ensure functionality and usability eg accessibilityease of use relevant and non-stigmatizing content
Aim 3 the basis for this registration will consist of an 8-week pilot of the refined DMBI intervention developed in Aim 2 among a separate group of patients to assess the feasibility and acceptability of DMBI among Black and Hispanic patients with IBD
Aim 2 will be guided by the needsbarriers identified in Aim 1 a functional DMBI app will be developed A formativesummative evaluation of the app intervention will be conducted through iterative patient user testing to ensure functionality and usability eg accessibilityease of use relevant and non-stigmatizing content
Aim 3 the basis for this registration will consist of an 8-week pilot of the refined DMBI intervention developed in Aim 2 among a separate group of patients to assess the feasibility and acceptability of DMBI among Black and Hispanic patients with IBD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None