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

Crohn Disease Clinical Trial

— COBMINDEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221254
• Other study ID #: SOR-0351-22-CTIL
• Secondary ID: SCRC22051MOH_202
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2024
• Source: Soroka University Medical Center
• Contact: Doron Schwartz, MD
• Phone: +972-52-3919044
• Email: DoronSh[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Rambam Health Care Campus i	Haifa
Israel	Belinson Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan

Sponsors (3)

Lead Sponsor	Collaborator
Soroka University Medical Center	Ben-Gurion University of the Negev, The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effects of intervention on microbiome	alpha + beta diversity	12 months
Secondary	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
Secondary	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
Secondary	Psychological improvment	Psychological self-report questionnaires; FACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Psychological improvment	Psychological self-report questionnaires; FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better.	12 months
Secondary	Psychological improvment	Psychological self-report questionnaires; SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.	12 months
Secondary	disease severity measurement	C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation.	12 months
Secondary	disease severity measurement	calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation.	12 months
Secondary	disease severity measurement	Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.	12 months