Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06221254

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

Led by Soroka University Medical Center · Updated on 2026-04-30

200

Participants Needed

4

Research Sites

208 weeks

Total Duration

On this page

Sponsors

S

Soroka University Medical Center

Lead Sponsor

T

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to participate and signed informed consent
  • Hebrew-speaking
  • Age 18 to 75 years
  • Confirmed diagnosis of Crohn's disease at least 3 months ago
  • Stable medical treatment for the last 3 months
  • Any Harvey Bradshaw Index score
  • Ability to operate a smartphone and use a mobile application
Not Eligible

You will not qualify if you...

  • 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 such as schizophrenia, major depression, or bipolar disorder
  • Alcohol or drug dependency (stable medical use of cannabinoids allowed)
  • Pregnancy or planned pregnancy during the study period
  • Clinically significant comorbidity
  • Previous participation in COBMINDEX trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Soroka University Medical Center

Beersheba, Israel, 8410101

Actively Recruiting

2

Rambam Health Care Campus i

Haifa, Israel, 3109601

Not Yet Recruiting

3

Belinson Medical Center

Petah Tikva, Israel, 4941492

Not Yet Recruiting

4

Sheba Medical Center

Ramat Gan, Israel, 5266202

Not Yet Recruiting

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Research Team

D

Doron Schwartz, MD

CONTACT

S

Shmuel Odes, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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