Crohn DiseaseNCT04861597
Digital Behavioral Interventions in Inflammatory Bowel Disease
A study testing Internet based cognitive behavioral therapy and Digital mood tracking in people with Crohn Disease and Ulcerative Colitis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Internet based cognitive behavioral therapy and Digital mood tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- race/ethnicity self-identified as Black/African American or Hispanic/Latino
- established diagnosis of Crohn's disease or ulcerative colitis
- elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale)
- internet access (smartphone/mobile device with data plan, computer with internet)
- ability to provide informed consent in English or Spanish
Who cannot join
- PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
- Current suicidal ideation, past suicidal attempt or hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Hutchinson Campus
The Bronx, New York, 10461
About this study
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.
Read the detailed description
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.
- Conditions
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety
- Being tested
- Internet based cognitive behavioral therapy, Digital mood tracking
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based cognitive behavioral therapyBehavioural
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
Digital mood trackingBehavioural
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Internet based cognitive behavioral therapy |
| 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. Receives: Behavioral: Digital mood tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-4 week trial intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Post-4 week trial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Nov 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ruby Greywoode, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861597
- Sponsor's protocol ID
- 2021-12896
- Other IDs
- UL1TR002556
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29366841Mikocka-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.
PubMed 26841224Mikocka-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.
PubMed 25934170Tiles-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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Behavioral Interventions in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04861597
- Acronym / sponsor ID
- 2021-12896
- Conditions
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy | Experimental | Behavioral: Internet based cognitive behavioral therapyThe 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 | Behavioral: Digital mood trackingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- race/ethnicity self-identified as Black/African American or Hispanic/Latino
- established diagnosis of Crohn's disease or ulcerative colitis
- elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale)
- internet access (smartphone/mobile device with data plan, computer with internet)
Key exclusion criteria (2 listed)
- PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
- Current suicidal ideation, past suicidal attempt or hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet based cognitive behavioral therapyParticipants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy | Behavioural | Internet-based cognitive behavioral therapy |
| Digital mood trackingParticipants with elevated psychological distress will receive 8 weeks of digital mood tracking | Behavioural | Digital mood tracking |
Primary outcome
Level of Psychological Distress
Time frame: Post-4 week trial intervention
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.
4 secondary outcomes
Disease Activity by Short Crohn's Disease Activity Index
Time frame: Post-4 week trial intervention
Disease Activity by Simple Clinical Colitis Activity Index
Time frame: Post-4 week trial intervention
Perceived Stress Score
Time frame: Post-4 week trial intervention
Health-related Quality-of-Life
Time frame: Post-4 week trial intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29366841Gracie 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.
- Background: PubMed 26841224Mikocka-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.
- Background: PubMed 25934170Mikocka-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.
- Derived from this study: PubMed 40243391Tiles-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruby Greywoode, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based cognitive behavioral therapy and Digital mood tracking in people with Crohn Disease and Ulcerative Colitis, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Psychological Distress (time frame: Post-4 week trial intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861597, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.