A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
NCT ID: NCT06221254
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-08-01
2026-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Ben-Gurion University of the Negev
OTHER
Soroka University Medical Center
OTHER
Responsible Party
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Dr Doron Schwartz
Senior Physician, Department of Gastroenterology and Hepatology
Principal Investigators
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Ruthie Bekore, MPH
Role: STUDY_DIRECTOR
Soroka University Medical Center
Ganit Goren, PhD
Role: STUDY_DIRECTOR
Ben-Gurion University of the Negev
Locations
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Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care Campus i
Haifa, , Israel
Belinson Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCRC22051
Identifier Type: OTHER
Identifier Source: secondary_id
MOH_2023-04-30_012589
Identifier Type: REGISTRY
Identifier Source: secondary_id
2203-05901
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SOR-0351-22-CTIL
Identifier Type: -
Identifier Source: org_study_id
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