AzTrials
AzTrials

Crohn DiseaseCOBMINDEXNCT06221254

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

A study testing COBMINDEX digital application in people with Crohn Disease, run by Soroka University Medical Center at 4 sites in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
COBMINDEX digital application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesIsrael
Study dates
1 Aug 2023to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Doron Schwartz, MD contact

+972-52-3919044

DoronSh@clalit.org.il

Shmuel Odes, MD contact

+972-52-2700752

odes@bgu.ac.il

Israel4 sites, 4 recruiting

  • Soroka University Medical Center

    Beersheba, 8410101

    Doron Schwartz, MD, +972523919044, DoronSh@clalit.org.il

    Shmuel Odes, MD, +97252700752, odes@bgu.ac.il

    Recruiting

  • Rambam Health Care Campus i

    Haifa, 3109601

    Haggai Bar-Yoseph, MD, +972-4-7772850, h_bar-yoseph@rambam.health.gov.il

    Not yet recruiting

  • Belinson Medical Center

    Petah Tikva, 4941492

    Henat Yanai, MD, +972-3-9377040, henitya@clalit.org.il

    Not yet recruiting

  • Sheba Medical Center

    Ramat Gan, 5266202

    Adi Lahat -Zok, Prof., +972-3-302197, zokadi@gmail.com

    Not yet recruiting

Other trials in Israel

About this study

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

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.

Read the 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.

Conditions
Crohn Disease
Being tested
COBMINDEX digital application, Human therapist (Control)
Keywords
Crohn's Disease, Health related quality of life, Cognitive behavioral therapy, Mindfulness, Immune regulation, Healthcare cost
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COBMINDEX digital applicationBehavioural

    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)Behavioural

    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.

Study groups in NCT06221254
Study groupRoleWhat they receive
Intervention- COBMINDEX applicationExperimentalThe 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.
Receives: Behavioral: COBMINDEX digital application
Control- COBMINDEX with Human therapistActive comparatorThe 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.
Receives: Behavioral: Human therapist (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (13)

  1. 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

    Measured: 12 months

  2. Effects of intervention on microbiome

    alpha + beta diversity

    Measured: 12 months

  3. Psychological improvment

    Psychological self-report questionnaires

    WPAI- Work Productivity and Activity Impairment. four types of scores:

    1. Absenteeism
    2. Presenteesism
    3. Work productivty loss
    4. Activity Impairment all presented in presentage 0-100. higher is worse.

    Measured: 12 months

  4. Psychological improvment

    Psychological self-report questionnaires

    SWLS -The 5-item scale 0-7 "satisfaction with life scale" range 0-35 higher is better.

    Measured: 12 months

  5. Psychological improvment

    Psychological self-report questionnaires

    FACIT-CD, FACIT Fatigue Scale 13-item measure 0-4. range 0-52 higher is worse.

    Measured: 12 months

  6. Psychological improvment

    Psychological self-report questionnaires

    Brief COPE- The Brief-COPE is a 28 item self-report questionnaire range 0-4 higher is worse.

    Measured: 12 months

  7. 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")

    Measured: 12 months

  8. Psychological improvment

    Psychological self-report questionnaires

    PSS-4, Perceived Stress Scale 4. 4-item 0-4 score. range 0-16 higher is worse.

    Measured: 12 months

  9. Psychological improvment

    Psychological self-report questionnaires

    FMI, Freiburg Mindfulness Inventory 14 items range 0-4 higher is better.

    Measured: 12 months

  10. Psychological improvment

    Psychological self-report questionnaires

    SUDS- Subjective Units of Distress Scale. range 0-100 higher is worse.

    Measured: 12 months

  11. disease severity measurement

    C Reactive Protein mg/dl 0- 100 normal range 0-0.5 higher means more inflammation.

    Measured: 12 months

  12. disease severity measurement

    calprotectin (microg/g) 0-8000 normal range 0-50 higher means more inflammation.

    Measured: 12 months

  13. disease severity measurement

    Harvey Bradshaw Index - Crohn's disease symptom score range 0-36. higher is worse.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start1 Aug 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
200 CD patients divided into two equal groups: Intervention and control.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221254
Sponsor's protocol ID
SOR-0351-22-CTIL
Other IDs
SCRC22051, MOH_2023-04-30_012589, 2203-05901
Acronym
COBMINDEX
Status last verified
Apr 2026
First submitted
31 Aug 2023
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing COBMINDEX digital application in people with Crohn Disease, run by Soroka University Medical Center at 4 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Doron Schwartz, MD (+972-52-3919044, DoronSh@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of application as compared to human therapist. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06221254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in