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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002556 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | 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. |
|
| Digital mood tracking | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet based cognitive behavioral therapy | Behavioral | Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-4 week trial intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruby Greywoode, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Hutchinson Campus | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29366841 | Background | Gracie DJ, Guthrie EA, Hamlin PJ, Ford AC. Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease. Gastroenterology. 2018 May;154(6):1635-1646.e3. doi: 10.1053/j.gastro.2018.01.027. Epub 2018 Jan 31. | |
| 26841224 | Background | Mikocka-Walus A, Knowles SR, Keefer L, Graff L. Controversies Revisited: A Systematic Review of the Comorbidity of Depression and Anxiety with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2016 Mar;22(3):752-62. doi: 10.1097/MIB.0000000000000620. |
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113 patients were approached at office their clinical visit. 83 patients were excluded; 37 declined to participate, 15 did not complete screening, and 31 patients were ineligible. 61 participants were consented into the study and 30 were enrolled; 18 randomized assigned to internet-Based Cognitive Behavioral Therapy arm (experimental arm), 12 randomized assigned to Digital Mood Tracking (control arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet-based Cognitive Behavioral Therapy (iCBT) | 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-inflammatory bowel disease (non-IBD) population. 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. Internet based cognitive behavioral therapy: Participants with elevated psychological distress will receive 4 weeks of internet-based cognitive behavioral therapy. |
| FG001 | Digital Mood Tracking | 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. Digital mood tracking: Participants with elevated psychological distress will receive 4 weeks of digital mood tracking. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet-based Cognitive Behavioral Therapy (iCBT) | 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. 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. Internet based cognitive behavioral therapy: Participants with elevated psychological distress will receive 4 weeks of internet-based cognitive behavioral therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Psychological Distress data was unable to be collected for 2 participants who completed the study in the iCBT arm. | Posted | Mean | Standard Deviation | T-score | Post-4 week trial intervention |
|
Period of trial enrollment per participants; subjects enrolled for 4 weeks, adverse event assessed post-4 week trial period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Internet-based Cognitive Behavioral Therapy (iCBT) | 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. 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. Internet based cognitive behavioral therapy: Participants with elevated psychological distress will receive 4 weeks of internet-based cognitive behavioral therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruby Greywoode M.D. M.S., Assistant Professor of Medicine | Montefiore Medical Center | 347-671-8205 | rgreywoode@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2022 | Jun 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2022 | Jun 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D013315 | Stress, Psychological |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Digital mood tracking | Behavioral | Participants with elevated psychological distress will receive 8 weeks of digital mood tracking |
|
| 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. | 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. | 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 | Post-4 week trial intervention |
| 25934170 | Background | Mikocka-Walus A, Bampton P, Hetzel D, Hughes P, Esterman A, Andrews JM. Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial. BMC Gastroenterol. 2015 May 2;15:54. doi: 10.1186/s12876-015-0278-2. |
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
| BG001 | Digital Mood Tracking | 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. Digital mood tracking: Participants with elevated psychological distress will receive 4 weeks of digital mood tracking. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. 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.
Internet based cognitive behavioral therapy: Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
| OG001 | Digital Mood Tracking | 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. Digital mood tracking: Participants with elevated psychological distress will receive 8 weeks of digital mood tracking |
|
|
| Secondary | 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. | sCDAI data was unable to be collected for 5 patients in the iCBT arm and 5 patients in the Digital Mood Tracking arm. | Posted | Mean | Standard Deviation | Index Score | Post-4 week trial intervention |
|
|
|
| Secondary | 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. | SCCAI data was unable to be collected for 75 patients in the iCBT arm and 4 patients in the Digital Mood Tracking arm. | Posted | Mean | Standard Deviation | Index Score | Post-4 week trial intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T-score | Post-4 week trial intervention |
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| Secondary | 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 | HRQoL data, other than Psychological Distress data, were not collected. | Posted | Post-4 week trial intervention |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Digital Mood Tracking | 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. Digital mood tracking: Participants with elevated psychological distress will receive 4 weeks of digital mood tracking. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |