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 December 21, 2024

Recruiting

Keywords

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

ClinConnect Summary

This clinical trial is studying the use of a smartphone application called COBMINDEX, which aims to help people with Crohn's disease manage their psychological wellbeing. The goal is to reduce stress, fatigue, and pain while improving overall quality of life and coping skills. The study will also look at how the app impacts the immune system and gut health of participants.

To participate in this trial, individuals must be between 18 and 75 years old, speak Hebrew, and have a confirmed diagnosis of Crohn's disease for at least three months. They should have stable medical treatment for the past three months and be comfortable using a smartphone. However, individuals with certain conditions, such as ulcerative colitis, recent surgeries, or serious psychiatric issues, will not be eligible. Participants can expect to engage with the app and share their experiences, which could help improve their mental and physical health related to Crohn's disease.

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

Trial Officials

Ruthie Bekore, MPH

Study Director

Soroka University Medical Center

Ganit Goren, PhD

Study Director

Ben-Gurion University of the Negev

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