Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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 (i.e., 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 (e.g. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age ≥ 18 years
self-identify as Black/African American and/or Hispanic/Latino(a/x)
diagnosed with Crohn's disease or ulcerative colitis
ability to provide informed consent in English
Disqualifiers
Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
Current suicidality, past suicide attempt, or psychiatric hospitalization.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Mind Body Intervention mobile application
BehavioralA DMBI mobile application with psychoeducation and skill-building in illness perception, coping, mindfulness, and disease acceptance informed by needs/barriers of Black and Hispanic patients with IBD who have elevated psychological distress and GI professionals caring for IBD patients.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Digital Mind Body InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility - DMBI recruitment rate
DMBI recruitment rate will be determined by the proportion of eligible patients who enroll into the trial. A benchmark to define this feasibility outcome will be ≥ 30% of eligible patients enrolling.
Time frame
8 weeks2
Feasibility - DMBI retention rate
DMBI Retention rate will be determined by the proportion of enrolled patients who complete all DMBI modules. A benchmark to define this feasibility outcome will be ≥ 70% of enrolled patients completing all DMBI modules.
Time frame
8 weeks3
Feasibility - DMBI adherence
DMBI adherence will be assessed by the percentage of completed activities per module will be determined. A benchmark to define this feasibility outcome will be ≥ 50% of completed activities per module.
Time frame
8 weeksSecondary outcomes
1
Illness Perception
The 8-item Brief Illness Perception Questionnaire (BIPQ) will be used to assess self-reported Illness Perception. Responses to the eight questions related are scored from 0 (negligible illness impact) to 10 (intense illness impact) for a possible scoring range of 0-80. Higher scores indicate more severe patient perception of illness impact. Group mean scores will be summarized.
Time frame
Week 0 (Baseline) and at 8 weeks2
IBD self-efficacy
IBD self-efficacy will be evaluated based on the 13-item IBD Self Efficacy Scale (IBD-SES) which measure the composite score across four domains of self-efficacy (managing stress and emotions, medical care, symptoms and disease, and maintaining remission). Responses to the 13 questions are scored from 0 (Not sure at all) to 10 (Totally sure) for a possible scoring range of 0-130. Higher scores are associated with increased patient self-efficacy across the four domains. Group mean scores will be summarized.
Time frame
Week 0 (Baseline) and at 8 weeks3
Disease acceptance
Patient disease acceptance will be assessed using the 20-item Digestive Disease Acceptance Questionnaire (DDAQ). The DDAQ consists of 20 statements asking patients to rate the truth of each statement on a scale ranging from 0 (Never True) to 6 (Always True) for an overall possible scoring range of 0-120. Higher scores are associated with increased patient disease acceptance. Group mean scores will be summarized.
Time frame
Week 0 (Baseline) and at 8 weeks4
Mindfulness
Mindfulness is evaluated based on the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15). The FFMQ measures mindfulness with regards to thoughts, experiences, and actions in daily life across five subscales. Responses to the positively worded statements (Statements 1-2, 5-6, 10-12, 15) are scored from 1 (Never or very rarely true) to 5 (Very often or always true). Responses to the negatively worded statements (Statements 3-4, 7-9, 13-14) are scored from 5 (Never or very rarely true) to 1 (Very often or always true) for an overall possible scoring range of 15-75. Higher scores are indicative of someone who is more mindful in their everyday life. Group mean scores will be summarized.
Time frame
Week 0 (Baseline) and at 8 weeksOther outcomes
1
Fecal Calprotectin Concentrations
Stool samples will be collected at baseline and 8 weeks to measure fecal calprotectin levels. Stool samples will be analyzed using ELISA or an immunochromatographic assay. Reference rages vary but concentrations between 50-120 ug/g are considered moderate/borderline. Fecal Calprotectin concentrations greater than 120 ug/g are considered high/abnormal. Group mean fecal calprotectin concentrations will be summarized. Fecal calprotectin can be a surrogate marker for IBD. High levels of fecal calprotectin are indicative of intestinal inflammation.
Time frame
Week 0 (Baseline) and at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Hureka Technologies
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
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