Search / Trial NCT06221254

A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease

Launched by SOROKA UNIVERSITY MEDICAL CENTER · Jan 14, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Crohn's Disease Health Related Quality Of Life Cognitive Behavioral Therapy Mindfulness Immune Regulation Healthcare Cost

Description

200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application. In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment. In the following...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Willingness to participate and signed informed consent
  • * Hebrew-speaking
  • * Age 18-75
  • * Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis
  • * Stable medical treatment for the last 3 months
  • * Any Harvey Bradshaw Index score
  • * Ability to operate a smartphone and cellular application
  • Exclusion Criteria:
  • * Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease
  • * Planned surgery for Crohn's disease
  • * Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months
  • * Psychiatric disease (schizophrenia, major depression or bipolar disorder)
  • * Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)
  • * Pregnancy or planned pregnancy during study period
  • * Clinically significant comorbidity
  • * Former participation in COBMINDEX trials

About Soroka University Medical Center

Soroka University Medical Center is a leading academic medical institution located in Beer Sheva, Israel, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a key player in the Israeli healthcare system, Soroka integrates cutting-edge medical practice with extensive educational programs, fostering a collaborative environment for researchers, clinicians, and students. The center specializes in a wide range of medical fields, emphasizing patient-centered care and evidence-based practices. With a focus on advancing medical knowledge and improving patient outcomes, Soroka University Medical Center actively sponsors and conducts clinical trials that contribute to significant breakthroughs in various therapeutic areas.

Locations

Be'er Sheva, , Israel

Ramat Gan, , Israel

Petah Tikva, , Israel

Haifa, , Israel

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0