Trial Outcomes & Findings for Digital Behavioral Interventions in Inflammatory Bowel Disease (NCT NCT04861597)
NCT ID: NCT04861597
Last Updated: 2024-09-19
Results Overview
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.
COMPLETED
NA
30 participants
Post-4 week trial intervention
2024-09-19
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
12
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Behavioral Interventions in Inflammatory Bowel Disease
Baseline characteristics by cohort
| Measure |
Internet-based Cognitive Behavioral Therapy (iCBT)
n=18 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 4 weeks of internet-based cognitive behavioral therapy.
|
Digital Mood Tracking
n=12 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-4 week trial interventionPopulation: Psychological Distress data was unable to be collected for 2 participants who completed the study in the iCBT arm.
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.
Outcome measures
| Measure |
Internet-based Cognitive Behavioral Therapy (iCBT)
n=10 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
|
Digital Mood Tracking
n=9 Participants
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
|
|---|---|---|
|
Level of Psychological Distress
|
60.8 T-score
Standard Deviation 5.6
|
59.4 T-score
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Post-4 week trial interventionPopulation: sCDAI data was unable to be collected for 5 patients in the iCBT arm and 5 patients in the Digital Mood Tracking arm.
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.
Outcome measures
| Measure |
Internet-based Cognitive Behavioral Therapy (iCBT)
n=7 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
|
Digital Mood Tracking
n=4 Participants
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
|
|---|---|---|
|
Disease Activity by Short Crohn's Disease Activity Index
|
118 Index Score
Standard Deviation 70
|
134 Index Score
Standard Deviation 69
|
SECONDARY outcome
Timeframe: Post-4 week trial interventionPopulation: SCCAI data was unable to be collected for 75 patients in the iCBT arm and 4 patients in the Digital Mood Tracking arm.
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.
Outcome measures
| Measure |
Internet-based Cognitive Behavioral Therapy (iCBT)
n=5 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
|
Digital Mood Tracking
n=5 Participants
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
|
|---|---|---|
|
Disease Activity by Simple Clinical Colitis Activity Index
|
6 Index Score
Standard Deviation 2
|
7 Index Score
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Post-4 week trial interventionLevel 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.
Outcome measures
| Measure |
Internet-based Cognitive Behavioral Therapy (iCBT)
n=12 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
|
Digital Mood Tracking
n=9 Participants
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
|
|---|---|---|
|
Perceived Stress Score
|
58 T-score
Standard Deviation 9
|
55 T-score
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Post-4 week trial interventionPopulation: HRQoL data, other than Psychological Distress data, were not collected.
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
Outcome measures
Outcome data not reported
Adverse Events
Internet-based Cognitive Behavioral Therapy (iCBT)
Digital Mood Tracking
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ruby Greywoode M.D. M.S., Assistant Professor of Medicine
Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place