Digital Behavioral Interventions in Inflammatory Bowel Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04861597

Enrollment

Registered

2021-04-27

Start date

2021-11-01

Completion date

2023-03-22

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety

Brief 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. 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.

Interventions

BEHAVIORALInternet based cognitive behavioral therapy

Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy

BEHAVIORALDigital mood tracking

Participants with elevated psychological distress will receive 8 weeks of digital mood tracking

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations) * Current suicidal ideation, past suicidal attempt or hospitalization

Design outcomes

Primary

Measure	Time frame	Description
Level of Psychological Distress	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.

Secondary

Measure	Time frame	Description
Disease Activity by Short Crohn's Disease Activity Index	Post-4 week trial intervention	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.
Disease Activity by Simple Clinical Colitis Activity Index	Post-4 week trial intervention	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.
Perceived Stress Score	Post-4 week trial intervention	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.
Health-related Quality-of-Life	Post-4 week trial intervention	Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29

Countries

United States

Participant flow

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	18
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.	12
Total	30

Baseline characteristics

Characteristic	Internet-based Cognitive Behavioral Therapy (iCBT)	Digital Mood Tracking	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	2 Participants	6 Participants
Age, Categorical Between 18 and 65 years	14 Participants	10 Participants	24 Participants
Race/Ethnicity, Customized Hispanic	10 Participants	8 Participants	18 Participants
Race/Ethnicity, Customized Non-Hispanic Black or African American	8 Participants	4 Participants	12 Participants
Region of Enrollment United States	18 participants	12 participants	30 participants
Sex: Female, Male Female	11 Participants	8 Participants	19 Participants
Sex: Female, Male Male	7 Participants	4 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 18	0 / 12
other Total, other adverse events	0 / 18	0 / 12
serious Total, serious adverse events	0 / 18	0 / 12

Outcome results

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.