Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility - DMBI recruitment rate
研究概览
简要总结
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.
详细描述
Prior to conducting the randomized pilot study, as part of Aim 1, virtual 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 needs/barriers identified in Aim 1, a functional DMBI app will be developed. A formative/summative evaluation of the app intervention will be conducted through iterative patient user testing to ensure functionality and usability (e.g. accessibility/ease 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. It is anticipated that Aim 3 will not initiate until July, 2027. Earlier Aims, not represented in this record, are in progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.
排除标准
- •Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
- •Current suicidality, past suicide attempt, or psychiatric hospitalization.
研究组 & 干预措施
Digital Mind Body Intervention
Participants randomized to the Digital Mind Body mobile intervention will receive a unique user identification (user ID) to access the DMBI mobile application. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control
干预措施: Digital Mind Body Intervention mobile application (Behavioral)
Waitlist Control
Patients randomized to the Waitlist Control arm/group will not receive the DMBI until the end of the study. During the study, to control for expectancy and attention, the Waitlist Control will receive a weekly email with generic tips on a healthy lifestyle in IBD. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control
结局指标
主要结局
Feasibility - DMBI recruitment rate
时间窗: 8 weeks
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.
Feasibility - DMBI adherence
时间窗: 8 weeks
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.
Feasibility - DMBI retention rate
时间窗: 8 weeks
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.
次要结局
- IBD Activity for Crohn's Disease (CD) Patients(Week 0 (Baseline) and at 8 weeks)
- Mindfulness(Week 0 (Baseline) and at 8 weeks)
- IBD self-efficacy(Week 0 (Baseline) and at 8 weeks)
- GI-specific symptom anxiety (GSA)(Week 0 (Baseline) and at 8 weeks)
- IBD Activity for Ulcerative Colitis (UC) Patients(Week 0 (Baseline) and at 8 weeks)
- Illness Perception(Week 0 (Baseline) and at 8 weeks)
- Disease acceptance(Week 0 (Baseline) and at 8 weeks)
- Resilience(Week 0 (Baseline) and at 8 weeks)
- Health-related Quality of Life(Week 0 (Baseline) and at 8 weeks)