RecruitingNot ApplicableNCT06221254

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

Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease


Sponsor

Soroka University Medical Center

Enrollment

200 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a smartphone app designed to support the psychological wellbeing of adults living with Crohn's disease — a chronic inflammatory bowel condition that can significantly impact quality of life and mental health. The goal is to see whether the app reduces anxiety, depression, and other emotional challenges in this population. **You may be eligible if...** - You are aged 18–75 with a confirmed Crohn's disease diagnosis (at least 3 months ago) - You are Hebrew-speaking - Your medical treatment has been stable for the past 3 months - You are able to use a smartphone and mobile app **You may NOT be eligible if...** - You have ulcerative colitis or unclassified inflammatory bowel disease (not Crohn's) - You are planning surgery or had significant Crohn's-related surgery in the last 3 months - You have a major psychiatric diagnosis (schizophrenia, major depression, or bipolar disorder) - You have alcohol or drug dependency - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCOBMINDEX digital application

COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques and practices using digital application.

BEHAVIORALHuman therapist (Control)

COBMINDEX is a Cognitive, behavioral and mindfulness-based stress reduction with daily self-exercise. The intervention comprises of 7 sessions in which stress reduction techniques are learned. In this arm the Patient learns techniques from a human therapist (the comperator for learning from the application) and practices using digital application.


Locations(4)

Soroka University Medical Center

Beersheba, Israel

Rambam Health Care Campus i

Haifa, Israel

Belinson Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

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NCT06221254


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