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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Behavioral: COBMINDEX digital application; Behavioral: Human therapist (Control)

Detailed 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 9-month period, all patients will practice using the application, each group by it's permissions.

There will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status.

Throughout the trial, adverse events and concomitant medications will be collected.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doron Schwartz, MD; Phone Number: +972-52-3919044; Email: DoronSh@clalit.org.il
• Study Contact Backup: Name: Shmuel Odes, MD; Phone Number: +972-52-2700752; Email: odes@bgu.ac.il

Study Locations

• Israel
  • Beersheba, Israel, 8410101
    • Recruiting
    • Soroka University Medical Center
    • Contact: Doron Schwartz, MD; Phone Number: +972523919044; Email: DoronSh@clalit.org.il
    • Contact: Shmuel Odes, MD; Phone Number: +97252700752; Email: odes@bgu.ac.il
  • Haifa, Israel, 3109601
    • Not yet recruiting
    • Rambam Health Care Campus i
    • Contact: Haggai Bar-Yoseph, MD; Phone Number: +972-4-7772850; Email: h_bar-yoseph@rambam.health.gov.il
  • Petah Tikva, Israel, 4941492
    • Not yet recruiting
    • Belinson Medical Center
    • Contact: Henat Yanai, MD; Phone Number: +972-3-9377040; Email: henitya@clalit.org.il
  • Ramat Gan, Israel, 5266202
    • Not yet recruiting
    • Sheba Medical Center
    • Contact: Adi Lahat -Zok, Prof.; Phone Number: +972-3-302197; Email: zokadi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention- COBMINDEX application; 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; 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.
Active Comparator: Control- COBMINDEX with Human therapist; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	To determine the cost-effectiveness of the intervention as provided by application versus therapists by prospective monitoring of direct and indirect healthcare costs. A cost-effectiveness analysis to assess the value for money of the application versus therapist interventions will be performed using primary data collected from patients in the study. These data include information of utilization of healthcare services reported by patients. The cost of each service will be based on the Israel Ministry of Health List Price for health services. We will calculate indirect costs of lost productivity based on patient responses to the WPAI questionnaire. For each patient we will calculate the quality-adjusted life-year (QALY) based on responses to the SF-12 questionnaires	12 months
Effects of intervention on microbiome	alpha + beta diversity	12 months
Psychological improvment	Psychological self-report questionnaires WPAI- Work Productivity and Activity Impairment. four types of scores: Absenteeism; Presenteesism; Work productivty loss; Activity Impairment all presented in presentage 0-100. higher is worse.	12 months
Psychological improvment	Psychological self-report questionnaires SWLS -The 5-item scale 0-7 "satisfaction with life scale" range 0-35 higher is better.	12 months
Psychological improvment	Psychological self-report questionnaires FACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse.	12 months
Psychological improvment	Psychological self-report questionnaires Brief COPE- The Brief-COPE is a 28 item self-report questionnaire range 0-4 higher is worse.	12 months
Psychological improvment	Psychological self-report questionnaires . BSI- The Brief Symptom Inventory a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely")	12 months
Psychological improvment	Psychological self-report questionnaires PSS-4, Perceived Stress Scale 4. 4-item 0-4 score. range 0-16 higher is worse.	12 months
Psychological improvment	Psychological self-report questionnaires FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better.	12 months
Psychological improvment	Psychological self-report questionnaires SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.	12 months
disease severity measurement	C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation.	12 months
disease severity measurement	calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation.	12 months
disease severity measurement	Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.	12 months

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; Ben-Gurion University of the Negev
• Investigators: Study Director: Ruthie Bekore, MPH, Soroka University Medical Center; Study Director: Ganit Goren, PhD, Ben-Gurion University of the Negev

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Mindfulness; Crohn's Disease; Health related quality of life; Immune regulation; Healthcare cost
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: SOR-0351-22-CTIL; SCRC22051 (Other Identifier: Soroka Clinical Research Center); MOH_2023-04-30_012589 (Registry Identifier: Ministry of Health MyTrial); 2203-05901 (Other Grant/Funding Number: The Leona M. and Harry B. Helmsley Charitable Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No