Inflammatory Bowel Diseases, Psychological Distress
Conditions
Brief summary
While people of color are an increasing segment of the inflammatory bowel disease (IBD) population, they are currently underrepresented in research, including studies of psychological distress. Appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of IBD activity has led to increased efforts to integrate psychological interventions into IBD medical care. Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. There are unanswered questions in the use of CBT in IBD: how to leverage digital technology to deliver CBT through internet-based cognitive behavioral therapy (iCBT); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? Thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with IBD and as racial or ethnic minority influence attitudes toward mental health and iCBT in a cohort of Black and Latino IBD patients with elevated psychological distress. Results will lead to adaptation of a CBT program into an iCBT app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.
Detailed description
The clinical trial component of this study (Aim 3) was never conducted. Only Aim 1, consisting of an assessment of the factors influencing acceptance and use of iCBT via semi-structured interviews, and which did not meet the definition of a clinical trial, was conducted as part of this study. The clinical trial component associated with this study, the internet-based cognitive therapy (iCBT), is being conducted as part of the Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease (DMBI), NCT06510296 (ID: 2024-16064) clinical trial.
Interventions
Cognitive behavioral therapy (CBT) is a form of psychotherapy in which individuals are taught to identify and modify maladaptive thinking and behavior to improve their psychological status and coping skills. CBT in this trial will be delivered digitally (internet-based).
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* self-identify as Black or Hispanic/Latino * diagnosis of Crohn's disease or ulcerative colitis * ability to provide informed consent in English * basic computer skills (i.e. ability to self-complete online questionnaire) * elevated psychological distress
Exclusion criteria
* severe psychological distress * active suicidality, past suicide attempt, or psychiatric hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 8 weeks | Proportion of eligible patients who enroll into the trial |
| Adherence Rate | 8 weeks | Number of activities and weekly sessions completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping | 8 weeks | Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience) |
| Crohn's Activity | 8 weeks | Level of symptomatic disease measured via Short Crohn's Disease Activity index |
| Illness Perception | 8 weeks | Cognitive and emotional representations formed about one's illness measured via Brief Illness Perception Questionnaire (minimum 0, maximum 80; higher scores indicate more severe illness impact) |
| Interleukin-6 level | 8 weeks | Inflammatory biomarker |
| Health related quality of life | 8 weeks | Quality of life measured via PROMIS-29 questionnaire (mean T score is 50, higher scores indicate higher degree of measured trait) |
| Ulcerative Colitis Activity | 8 weeks | Level of symptomatic disease measured via Simple Clinical Colitis Activity index |
| Self-efficacy | 8 weeks | A task-specific construct of the perception of one's ability to manage a given situation measured via PROMIS-Self Efficacy in Managing Emotions questionnaire (T score 50 is the mean, higher scores indicate greater self efficacy) |
Outcome results
None listed