Clinical trial NCT06221254: A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Official title: Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn's Disease
Health related quality of life
Cognitive behavioral therapy
Mindfulness
Immune regulation
Healthcare cost
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: Ben-Gurion University of the Negev
First posted: 2024-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 CD patients divided into two equal groups: Intervention and control.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of application as compared to human therapist.
timeFrame: 12 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 12 months
measure: Effects of intervention on microbiome
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: Psychological improvment
timeFrame: 12 months
measure: disease severity measurement
timeFrame: 12 months
measure: disease severity measurement
timeFrame: 12 months
measure: disease severity measurement
timeFrame: 12 months
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus i
city: Petah Tikva
country: Israel
facility: Belinson Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Ruthie Bekore, MPH
role: STUDY_DIRECTOR
affiliation: Ben-Gurion University of the Negev
name: Ganit Goren, PhD
role: STUDY_DIRECTOR
References: