Digital Behavioral Interventions in Inflammatory Bowel Disease

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04861597
Study type	Interventional
Source	Montefiore Medical Center
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2021
Completion date	March 22, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05702879` - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting	`NCT05953402` - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT03950232` - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	Phase 3
Completed	`NCT03124121` - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Phase 4
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Withdrawn	`NCT04209556` - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT04398550` - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis	N/A
Recruiting	`NCT04314375` - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Phase 4
Active, not recruiting	`NCT04857112` - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis	Phase 2
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting	`NCT04033445` - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Phase 2/Phase 3
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting	`NCT06221995` - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting	`NCT04767984` - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis	Phase 2
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Completed	`NCT03760003` - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	Phase 2
Not yet recruiting	`NCT05539625` - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Phase 2