A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
Not applicable · Testing COBMINDEX digital application and Human therapist (Control) · 4 sites · Soroka University Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing COBMINDEX digital application (a behavioral program) and Human therapist (Control) (a behavioral program) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Willingness to participate and signed informed consent
- Hebrew-speaking
- Age 18-75
Plus 4 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2023-08-01.
- Main results expected around 2027-05-31 (estimate from the record).
- 4 study sites listed (1 marked recruiting) in Israel.
Main thing being measured
- Effectiveness of application as compared to human therapist. (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Soroka University Medical Center |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust; Ben-Gurion University of the Negev |
| Enrollment | 200 (estimated) |
| Start date | 2023-08-01 |
| Primary completion (est.) | 2027-05-31 |
| First posted | 2024-01-24 |
| Last updated | 2026-04-30 |
| Official title | Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease |
| ClinicalTrials.gov ID | NCT06221254 |
Interventions
- COBMINDEX digital application (Behavioral)
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) (Behavioral)
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.
Full eligibility criteria (from the record)
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
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Soroka University Medical Center | Beersheba | Israel | Recruiting |
| Rambam Health Care Campus i | Haifa | Israel | Not yet recruiting |
| Belinson Medical Center | Petah Tikva | Israel | Not yet recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.