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

Soroka University Medical Center

Status: Enrolling

Conditions: Crohn Disease

Treatments: Behavioral: COBMINDEX digital application; Behavioral: Human therapist (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT06221254

SOR-0351-22-CTIL

SCRC22051 (Other Identifier)

2203-05901 (Other Grant/Funding Number)

MOH_2023-04-30_012589 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention- COBMINDEX application

Experimental group

Description:

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.

Treatment:

Behavioral: COBMINDEX digital application

Control- COBMINDEX with Human therapist

Active Comparator group

Description:

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.

Treatment:

Behavioral: Human therapist (Control)