An interventional study of Internet based cognitive behavioral therapy and Digital mood tracking in Crohn Disease, Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.
The investigators propose a 1:1 randomized trial design to evaluate the efficacy of iCBT among a population of Black and Latinx IBD patients and to assess factors influencing its implementation. Patients within the integrated health system at Montefiore Medical Center will be actively recruited and screened to identify those with elevated psychological distress.
Eligible patients will be randomized to receive 8 weeks of iCBT or digital mood tracking to evaluate the effect of iCBT on levels of psychological distress, HRQoL and disease activity post-intervention. The investigators will also evaluate individual process level barriers and facilitators to iCBT implementation via surveys and semi-structured interviews.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.
Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.
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Exclusion Criteria:
The iCBT platform selected for use in this study (Sanvello™) is an evidence-based mobile app created by clinical experts that has been shown to decrease depression, anxiety, and stress and to increase self-efficacy in a non-IBD population.15 App features include: daily mood tracking; guided journeys (e.g. psychoeducational content providing background information about cognitive behavioral therapy and instructing users on how to use app tools to maintain motivation and interest); coping tools (e.g. meditation, goal setting, and negative thought redirecting activities); weekly progress assessments; community support board.
Behavioral: Internet based cognitive behavioral therapy
The digital mood tracking application (app) selected for this study (PixelTM) allows participants to log their mood each day by way of a facial expression emoji and a free-text box. This app is commercially available free of charge through iOS and Android app stores with English and Spanish language options.
Behavioral: Digital mood tracking
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking
Level of Psychological Distress
Level of psychological distress in participants over the prior 7 days was measured by combining the sub-score domains of anxiety and depression from the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) assessment tool. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of anxiety and depression. Group mean scores of these 8 items are composited. Higher scores indicate a greater level of the measured trait, and raw scores are converted to a T-score that centers at a mean of 50 with a standard deviation of 10 in the general population.
Time frame: Post-4 week trial intervention
Disease Activity by Short Crohn's Disease Activity Index
Disease activity over the prior 7 days for Crohn's disease patients will be measured using the Short Crohn's Disease Activity Index (sCDAI). The sCDAI consists of three variables identified as predictors of disease activity: diarrhea frequency (number of liquid or soft stools), abdominal pain, and general well-being. Scoring was calculated as follows to calculate an overall score: 44 + (2 x the number of liquid or soft stools each day for 7 days) + 5 x the sum of seven daily abdominal pain ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) + 7 x the sum of seven general well-being ratings (0 = generally well, 1 = slightly under par, 2 = poor, 3 = very poor, 4 = terrible). Overall scoring ranged from 44 to an undefined upper limit based on diarrhea frequency with increasing scores being indicative of more Crohn's disease activity. Group scores were summarized using basic descriptive statistics.
Time frame: Post-4 week trial intervention
Disease Activity by Simple Clinical Colitis Activity Index
Disease activity over the prior 7 days in Ulcerative Colitis patients will be measured using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., uveitis, pyoderma gangrenosum, erythema nodusum, and arthropathy). Scores are summarized for an overall possible scoring range of 0-19 with increasing scores being indicative of more colitis activity. Group scores were summarized using basic descriptive statistics.
Time frame: Post-4 week trial intervention
Perceived Stress Score
Level of perceived stress in IBD patients was measured using the NIH Toolbox Item Bank/Fixed Form v2.0. This form consists of 10 questions or statements used to assess perceptions of stress in IBD patients over the past month. Responses to the 10 items are scored on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Very Often"). Raw scores are auto-converted to a T-score that centers at a mean score of 50 with a Standard Deviation (SD) of 10. Higher scores are indicative of higher levels of the trait (perceived stress). Group scores were summarized using basic descriptive statistics.
Time frame: Post-4 week trial intervention
Health-related Quality-of-Life
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
Time frame: Post-4 week trial intervention
| Milestone | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking |
|---|---|---|
| Started | 18 | 12 |
| Completed | 12 | 9 |
| Not completed | 6 | 3 |
Level of psychological distress in participants over the prior 7 days was measured by combining the sub-score domains of anxiety and depression from the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) assessment tool. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of anxiety and depression. Group mean scores of these 8 items are composited. Higher scores indicate a greater level of the measured trait, and raw scores are converted to a T-score that centers at a mean of 50 with a standard deviation of 10 in the general population.
| T-score | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking |
|---|---|---|
| Level of Psychological Distress | 60.8 ± 5.6 | 59.4 ± 8.8 |
Disease activity over the prior 7 days for Crohn's disease patients will be measured using the Short Crohn's Disease Activity Index (sCDAI). The sCDAI consists of three variables identified as predictors of disease activity: diarrhea frequency (number of liquid or soft stools), abdominal pain, and general well-being. Scoring was calculated as follows to calculate an overall score: 44 + (2 x the number of liquid or soft stools each day for 7 days) + 5 x the sum of seven daily abdominal pain ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) + 7 x the sum of seven general well-being ratings (0 = generally well, 1 = slightly under par, 2 = poor, 3 = very poor, 4 = terrible). Overall scoring ranged from 44 to an undefined upper limit based on diarrhea frequency with increasing scores being indicative of more Crohn's disease activity. Group scores were summarized using basic descriptive statistics.
| Index Score | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking |
|---|---|---|
| Disease Activity by Short Crohn's Disease Activity Index | 118 ± 70 | 134 ± 69 |
Disease activity over the prior 7 days in Ulcerative Colitis patients will be measured using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., uveitis, pyoderma gangrenosum, erythema nodusum, and arthropathy). Scores are summarized for an overall possible scoring range of 0-19 with increasing scores being indicative of more colitis activity. Group scores were summarized using basic descriptive statistics.
| Index Score | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking |
|---|---|---|
| Disease Activity by Simple Clinical Colitis Activity Index | 6 ± 2 | 7 ± 4 |
Level of perceived stress in IBD patients was measured using the NIH Toolbox Item Bank/Fixed Form v2.0. This form consists of 10 questions or statements used to assess perceptions of stress in IBD patients over the past month. Responses to the 10 items are scored on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Very Often"). Raw scores are auto-converted to a T-score that centers at a mean score of 50 with a Standard Deviation (SD) of 10. Higher scores are indicative of higher levels of the trait (perceived stress). Group scores were summarized using basic descriptive statistics.
| T-score | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking |
|---|---|---|
| Perceived Stress Score | 58 ± 9 | 55 ± 11 |
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
No measurements were reported for this outcome.
Collected over Period of trial enrollment per participants; subjects enrolled for 4 weeks, adverse event assessed post-4 week trial period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Internet-based Cognitive Behavioral Therapy (iCBT) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Digital Mood Tracking | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 10 | 24 |
| >=65 years | 4 | 2 | 6 |
| Sex: Female, Male(Participants) | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking | Total |
|---|---|---|---|
| Female | 11 | 8 | 19 |
| Male | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking | Total |
|---|---|---|---|
| Hispanic | 10 | 8 | 18 |
| Non-Hispanic Black or African American | 8 | 4 | 12 |
| Region of Enrollment(participants) | Internet-based Cognitive Behavioral Therapy (iCBT) | Digital Mood Tracking | Total |
|---|---|---|---|
| United States | 18 | 12 | 30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Nov 2021 to primary completion in Mar 2023, 16 months.
Results were first posted in Sep 2024, 1 year 5 months after primary completion.
Of 280 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 67. This study's 16 months is below that.
Counting every sponsor, half of 289 studies reached it within 45 months; a quarter within 22 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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