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

NCT06221254 | Recruiting

• 4 other identifiers: SOR-0351-22-CTILSCRC22051MOH_2023-04-30_0125892203-05901
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Crohn Disease

Keywords

Crohn's Disease; Health related quality of life; Cognitive behavioral therapy; Mindfulness; Immune regulation; Healthcare cost

Outcome Measures

Primary Outcomes (1)

• Effectiveness of application as compared to human therapist.

  Develop a smartphone application that will teach the patient COBMINDEX and to determine whether the application will be as effective as the psychological intervention delivered by the therapists. the primary end point is SIBDQ disease specific HRQOL. 10 questions each scale 1-7 with range 7-70. higher is better.

  12 months

Secondary Outcomes (13)

• Cost-effectiveness

  12 months

• Effects of intervention on microbiome

  12 months

• Psychological improvment

  12 months

• Psychological improvment

  12 months

• Psychological improvment

  12 months

Study Arms (2)

Intervention- COBMINDEX application

EXPERIMENTAL

The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise using a research dedicated application. Than, additional 9 months of practicing daily only with the application.

Behavioral: COBMINDEX digital application

Control- COBMINDEX with Human therapist

ACTIVE COMPARATOR

The intervention in this arm is to learn during the first 3 months, cognitive, behavioral and mindfulness based stress reduction with daily exercise with human therapist, and than practicing daily only with the application.

Behavioral: Human therapist (Control)

Interventions

COBMINDEX digital application BEHAVIORAL

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.

Intervention- COBMINDEX application

Human therapist (Control) BEHAVIORAL

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.

Control- COBMINDEX with Human therapist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Ben-Gurion University of the Negev: collaborator

Study Sites (4)

Soroka University Medical Center

Beersheba, 8410101, Israel

RECRUITING

Rambam Health Care Campus i

Haifa, 3109601, Israel

NOT YET RECRUITING

Belinson Medical Center

Petah Tikva, 4941492, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, 5266202, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ruthie Bekore, MPH

  Soroka University Medical Center

  STUDY DIRECTOR

• Ganit Goren, PhD

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

Central Study Contacts

Doron Schwartz, MD

CONTACT

+972-52-3919044; DoronSh@clalit.org.il

Shmuel Odes, MD

CONTACT

+972-52-2700752; odes@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician, Department of Gastroenterology and Hepatology

Model Details: 200 CD patients divided into two equal groups: Intervention and control.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: January 24, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)