Crohn's Disease ColonNCT05085925

Mindfulness-Based Stress-Reduction in Patients With Crohn's Disease

A study testing Cognitive behavioral mindfulness intervention and Cognitive behavioral mindfulness intervention after 3-month wait list in people with Crohn's Disease Colon, run by Soroka University Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Crohn's Disease Colon
What is being tested?: Cognitive behavioral mindfulness intervention and Cognitive behavioral mindfulness intervention after 3-month wait list
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteIsrael
Study dates: 13 Jun 2018to 16 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Willingness to participate and commit to a one-year process
Age 18-75 years
Hebrew-speaking
Proven diagnosis of mild/moderate Crohn's disease
At least 3 months post-diagnosis

Who cannot join

Crohn's disease that is severe (HBI >16) or in remission (HBI<5)
Ulcerative colitis, IBD unclassified
Planned surgery or surgery in last 6 months
Psychiatric disease
Psychotropic medication
Alcohol or drug dependency
Pregnancy
Significant or poorly controlled comorbidity

Trial locations and contacts

1 site in 1 country.

Israel1 site

Soroka University Medical Center
Beersheba

Other trials in Israel

About this study

Official title: Randomized Intervention Study of Mindfulness-Based Stress-Reduction to Improve the Quality of Life and Immune Regulation in Patients With Crohn's Disease

A randomized controlled study which aims to improve the quality of life of Crohn's disease adult patients suffering from mild to moderate level of symptoms. Patients will be randomized to Intervention or Wait-List groups and will undergo eight Cognitive Behavioral and Mindfulness, one on one, sessions with a social worker via SkypeTM. The Intervention group will receive intervention upon recruitment while the Wait-List group will receive the same intervention after 3 months. Clinical, biological and psycho-social data will be collected at four time points over the 12-months of the study.

Read the detailed description

Overall objectives:
Primary outcome: To determine whether mindfulness-based stress reduction will lead to a better health-related quality-of-life by use of three questionnaires:

the Crohn's disease specific SIBDQ (Short Inflammatory Bowel Disease Questionnaire, with mean score and 4 subscales: bowel, systemic, social, emotional)
SF-12 (MOS Short-Form-12) which is derived from the generic SF-36 used in our previous research (SF-36 measures a Physical Health Summary Score comprised of physical functioning, role-physical, bodily pain and general health, and a Mental Health Summary Score comprised of vitality, role-emotional, social functioning and mental health).
EQ-5D (EuroQol questionnaire, for calculation of utility weights)

Secondary outcomes: improvement in mindfulness (FMI, Freiburg Mindfulness Inventory); reduction of stress, anxiety and depression (BSI - Brief Symptom Inventory, GSI - General Severity Index stress measure, MSPSS- Multidimensional Scale of Perceived Social Support, PSS-4 Perceived Stress Scale, LEQ- life events questionnaire); better satisfaction with life (SWLS, Satisfaction with Life Scale); improved family function (FAD, Family Assessment Device); pain reduction (HBI, Harvey-Bradshaw Index of activity of Crohn's disease); less fatigue (FACIT Fatigue Scale); better coping with disease (COPE: Brief Cope Inventory - Brief Coping Operations Preference Enquiry); better performance at work (WPAI, Work Productivity and Activity Impairment) and cost estimation. Significant changes in the scores of these questionnaires, based on our current work comparing P-HBI remission versus active disease, are the following (all are given in points, except WPAI is percent): SIBDQ 6, SWLS 5, FAD 0.15, COPE dysfunctional 2.5, COPE emotion-focused 0.7, COPE problem-focused 0.6, WPAI time missed 14, WPAI percent impairment 29, WPAI work impairment 28, WPAI activity impairment 30, GSI 0.6, BSI anxiety 0.6, BSI depression 0.6. We did not use the SF-12, EQ-5D, MSPSS, PSS-4 and the FACIT Fatigue Scale in our previous research and will look at reports in the literature and our newly acquired data to determine what are significant improvements.
Before and at the end of each intervention session a short assessment of patient's subjective units of distress (SUDS) will be done, as per Wolpe, Joseph (1969), The Practice of Behavior Therapy, New York: Pergamon Press, and the 4 question Short-Form Perceived Stress Scale, as per Warttig et al, J Health Psychology 2013;18:1617-28.
Correlations of psychological measures with demography, economic status, HBI, immune regulation, telomere shortening, fMRI data, changes in composition of microbiota. Change in biophysical parameters as sleep physical activity \& pulse rate.
To determine whether the intervention is cost-saving or cost-effective, by prospective monitoring of resource use and indirect costs.
To determine whether the intervention can be given effectively using telemedicine with Skype or alternative software.
To study patient acceptability of the intervention, including recruitment and drop-out rate, and the adherence rate to home practice of the stress reduction measure taught.
Expected outcomes
Reduced HBI, improvement of all the psychological measures including both quality-of-life and satisfaction with life, less stress, less fatigue, more use of adaptive coping strategies, with no clear improvements in the control group. Improvement in biophysical parameters as sleep physical activity \& pulse rate.
The research will identify the best form of delivering the interventional therapy and if it is cost-saving or cost-effective.
Confirmation of the reliability of measurements of modification of immune regulation mechanisms and telomere length, grey matter thickness and composition of the microbiota.
Glucocorticoid resistance and related laboratory determinations on patients' leukocytes will add to understanding the biological mechanisms associated with stress-induced pathogenic autoimmunity in the patients in a sex-dependent manner. This will add to our understanding the biological mechanisms associated with stress in Crohn's disease.
Work plan and methodology
Patient recruitment i. Patients: 200 patients being treated at all the participating hospitals (Soroka Medical Center, Rambam Health Campus, Sheba Medical Center, Rabin Medical Center, Shaare Zedek Medical Center), which all have electronic records of large cohorts of patients with Crohn's disease and by advertising through patient support groups and institutions upon approval. The recruitment of patients will be offered in all the hospitals. Preference will be given to patients who have participated in the previous IIRN study and are now participating in the new IIRN studies proposed by the other hospitals, and those patients in higher risk groups (poorer men, female gender, etc.). iv. Patients on a fixed dose of corticosteroids and those who received corticosteroid therapy in last 6 months will present a special sub-group on whom the laboratory studies of cortisol and glucocorticoid resistance may differ significantly from patients not on this treatment, but this will have to be verified by measurements in a small sample to determine the magnitude of the effect before a decision to include or exclude these individuals.
Patients with change of diagnosis in the course of the study period will be excluded from the final analysis. vi. Ethical considerations: This protocol will need approval of the Ethics Committee at all hospitals prior to commencement of patient recruitment and access of patient data at these hospitals. A signed informed consent form will be obtained from each participant.
Assessment of patient status i. Medical status (HBI) and phenotype. No attempt will be made to modify the patients' treatments. ii. Psycho-social self-report questionnaires: demography, economic status, SIBDQ, EQ-5D, SF-12, WPAI, SWLS, FACIT, COPE, FAD, BSI, GSI, FMI, MSPSS, PSS-4, LEQ. iii. Objective outcomes:
HBI, CRP, calprotectin, relevant imaging studies (radiology, endoscopy) biophysical parameters as sleep physical activity \& pulse rate.
Special tests on all or selected sub-sets of patients: immune regulation, telomeres, fMRI, and microbiota.
Biophysical parameters as sleep physical activity \& pulse rate will be monitored in 30 patients by using commercially available smart watches.
Psycho-social interventions i. The sample size calculation is based on α = 0.05, power = 0.8, SD = 14 (data from our current research) in order to achieve a 6-point change in the SIBDQ (the primary endpoint). Thus, the cohort will consist of 172 patients computer-randomized to two groups; 86 patients with mindfulness-based stress reduction, and 86 wait-list controls that will enter the intervention phase after 3 months. In order to allow for a 15% expected drop-out rate, these recruitment numbers may need to be increased to 200 patients. An equal number of women and men will be recruited at each hospital. ii. The group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5. This group will have 4 time points for assessment (see Table, below). iii. Wait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions. The reason for wait-listing is to ensure that there will be a control group to parallel the first 3 months of intervention therapy in the patients getting the therapy from the start. The control group will have the same time points for data assessment as the intervention group. iv. All interventions will be individual sessions. v. Patients will be accessed via internet apps such as Skype. vi. Mindfulness-based stress reduction is to be given by specially trained therapists: These are social workers (PhD or Masters candidate level), who have undergone a training session program provided by relevant researchers of this protocol (including clinicians) as well as invited outside psychologists and psychiatrists with specialization in this field. vii. Psycho-social, medical and biological data will be collected at the measurement points T1, T2, T3 and T4 (see Table) in all patients. fMRI (to be performed at Soroka Medical Center, without use of contrast) and microbiota studies (stool samples) will be performed on a subset of patients.
Health-care cost i. Direct costs: admissions to hospital, surgery, consultations (primary care physicians, specialists, dieticians, social services) investigations and medications, travel costs to medical facilities. ii. Indirect costs: lost workdays, lost productivity, disability payments, travel costs and expenses of escorts.
Immune regulation studies, glucocorticoid resistance in lymphocytes, telomeres i. Blood collections (see Table of events, below) will be performed on consenting patients with Crohn's disease before and after Mindfulness-based stress reduction at 3 time points, as well as in age- and gender-matched consenting healthy volunteer controls (consenting patients without inflammatory diseases attending at the Gastroenterology Department at Soroka Medical Center for screening endoscopies) at one time points. ii. Blood will be drawn immunological and telomere studies.
Immunology: Blood is sampled twice from 60 Crohn's disease and from 60 controls for isolation of serum and peripheral blood mononuclear cell aliquots at enrollment and after Mindfulness-based stress reduction (provided these patients enter a phase of remission). Serum measures will include plasma C-reactive protein (CRP), ACTH, CBG and sex hormones. Similarly, peripheral blood mononuclear cell will undergo functional immune phenotyping of disease-implicated T cell and B cell subsets and assessments of their glucocorticoid resistance. Glucocorticoid signaling experiments will be performed in purified pro-inflammatory lymphocyte subsets found to exhibit glucocorticoid resistance. Results will be correlated with all other measures in this proposal. Controls for these tests will be matched healthy volunteers. The same tests will be carried out in the controls.
Telomere studies in 30 patients with Crohn's disease and 30 controls: by TeloTAGGG™ Telomere Length Assay (Merck). Two blood samples will be needed (see Table of events, below) f. Stool testing - stool samples will be collected at T1 and T2 i. Calprotectin will be measured in the stool at T1 and T2. ii. Microbiota study will be performed on 30 intervention patients and 30 control patients.
fMRI - A non-contrast brain MRI will be performed on 30 intervention and 30 control patients at T1 and T2

Conditions: Crohn's Disease Colon
Being tested: Cognitive behavioral mindfulness intervention, Cognitive behavioral mindfulness intervention after 3-month wait list
Keywords: Crohn's Disease, Health-related quality of life, Cognitive behavioral therapy, Mindfulness, Healthcare cost, Immune regulation
Medical subject headings: Crohn Disease

What participants receive

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

Cognitive behavioral mindfulness interventionBehavioural
The group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5
Cognitive behavioral mindfulness intervention after 3-month wait listBehavioural
Wait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions.

Study groups in NCT05085925
Study group	Role	What they receive
Cognitive behavioral mindfulness intervention at entry	Experimental	Cognitive behavioral mindfulness intervention at entry Receives: Behavioral: Cognitive behavioral mindfulness intervention
Cognitive behavioral mindfulness intervention after 3 months	Active comparator	Cognitive behavioral mindfulness intervention after 3 months of wait list Receives: Behavioral: Cognitive behavioral mindfulness intervention after 3-month wait list

What is being measured

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

Change in Crohn's disease specific health-related quality of life
Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Range: 10-70; Higher score indicates better quality of life
Measured: Measured at baseline, 3-months, 6-months, 12-months
Change in general health profile
Measured by the Short Form-12 (SF-12); 0-100; Higher scores indicate better quality of life
Measured: Measured at baseline, 3-months, 6-months, 12-months
Change in utility weights
Measured by the EuroQoL (EQ-5D-3L); 0-1; Higher scores indicate higher and better utility weights
Measured: Measured at baseline, 3-months, 6-months, 12-months

Secondary outcomes (11)

Social support
Measured by the Multidimensional Scale of Perceived Social Support: Family, friends and significant other (MSPSS); 1-7; Higher scores indicate better support
Measured: Measured at baseline, 3-months, 6-months, 12-months
Stress, anxiety and depression
Measured by BSI - Brief Symptom Inventory, GSI - General Severity Index stress measure, MSPSS- Multidimensional Scale of Perceived Social Support, PSS-4 Perceived Stress Scale, LEQ- life events questionnaire
Measured: Measured at baseline, 3-months, 6-months, 12-months
Perceived stress
Measured by the Perceived Stress Scale (Pass-4); 0-16; Higher score indicated higher stress
Measured: Measured at baseline, 3-months, 6-months, 12-months
Satisfaction with life
Measured by SWLS, Satisfaction with Life Scale; 5-35; Higher score indicates higher satisfaction with life
Measured: Measured at baseline, 3-months, 6-months, 12-months
Fatigue
Measured by FACIT-Fatigue Scale; 0-52; Higher score indicates better outcome
Measured: Measured at baseline, 3-months, 6-months, 12-months
Pain reduction
Measured by the Harvey-Bradshaw Index (HBI) of activity of Crohn's disease
Measured: Measured at baseline, 3-months, 6-months, 12-months
Coping with disease
Measured by the Brief Coping Operations Preference Enquiry (COPE). HIgher score indicates higher usage of coping strategy
Problem focus coping strategy (COPE PFS) subscale; 0-24; Higher score means higher use of this efficient mechanism.
Emotional focused coping strategy (COPE EFS) subscale; 10-40; Higher score means higher use of this controversial mechanism.
Dysfunctional focus coping strategy (COPE DFS) subscale; 12-48; Higher score means higher use none-efficient mechanism.
Measured: Measured at baseline, 3-months, 6-months, 12-months
Performance at work
Measured with WPAI, Work Productivity and Activity Impairment
Measured: Measured at baseline, 3-months, 6-months, 12-months
Resource utilization and healthcare costs
Patient self report
Measured: Measured at baseline, 3-months, 6-months, 12-months
Mindfulness
Self report of patient's mindfulenss level, measured with FMI (Freiburg Mindfulness Inventory); 14-56; higher score indicates a greater self percived mindfulness level
Measured: Measured at baseline, 3-months, 6-months, 12-months
Family Support
Self report of patient's family support, measured with FAD (Family Assessment Device);
Measured: Measured at baseline, 3-months, 6-months, 12-months

Timeline

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

13 Jun 201816 Jul 2021

First posted20 Oct 2021
Study start13 Jun 2018
Primary completion8 Jun 2020
Study completion16 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Crohn's Disease ColonStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05085925
Sponsor's protocol ID: SOR- 0063-20-CTIL
Other IDs: 2018PG-CD005
Status last verified: Oct 2021
First submitted: 18 Feb 2020
Last updated: 20 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Goren G, Schwartz D, Friger M, Sergienko R, Monsonego A, Slonim-Nevo V, Greenberg D, Odes S, Sarid O. Gender Differences in Coping Strategies and Life Satisfaction Following Cognitive-Behavioral and Mindfulness-Based Intervention for Crohn's Disease: A Randomized Controlled Trial. J Clin Med. 2025 Feb 26;14(5):1569. doi: 10.3390/jcm14051569.
PubMed 40095500

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Intervention Study of Mindfulness-Based Stress-Reduction to Improve the Quality of Life and Immune Regulation in Patients With Crohn's Disease
ClinicalTrials.gov ID: NCT05085925
Acronym / sponsor ID: SOR- 0063-20-CTIL
Conditions: Crohn's Disease Colon
Keywords: Crohn's Disease, Health-related quality of life, Cognitive behavioral therapy, Mindfulness, Healthcare cost, Immune regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Soroka University Medical CenterUniversity, hospital or other
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Study start: 13 Jun 2018 (actual)
Primary completion: 8 Jun 2020 (actual)
Study completion: 16 Jul 2021 (actual)
First posted: 20 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Overall objectives:
Primary outcome: To determine whether mindfulness-based stress reduction will lead to a better health-related quality-of-life by use of three questionnaires:

the Crohn's disease specific SIBDQ (Short Inflammatory Bowel Disease Questionnaire, with mean score and 4 subscales: bowel, systemic, social, emotional)
SF-12 (MOS Short-Form-12) which is derived from the generic SF-36 used in our previous research (SF-36 measures a Physical Health Summary Score comprised of physical functioning, role-physical, bodily pain and general health, and a Mental Health Summary Score comprised of vitality, role-emotional, social functioning and mental health).
EQ-5D (EuroQol questionnaire, for calculation of utility weights)

Secondary outcomes: improvement in mindfulness (FMI, Freiburg Mindfulness Inventory); reduction of stress, anxiety and depression (BSI - Brief Symptom Inventory, GSI - General Severity Index stress measure, MSPSS- Multidimensional Scale of Perceived Social Support, PSS-4 Perceived Stress Scale, LEQ- life events questionnaire); better satisfaction with life (SWLS, Satisfaction with Life Scale); improved family function (FAD, Family Assessment Device); pain reduction (HBI, Harvey-Bradshaw Index of activity of Crohn's disease); less fatigue (FACIT Fatigue Scale); better coping with disease (COPE: Brief Cope Inventory - Brief Coping Operations Preference Enquiry); better performance at work (WPAI, Work Productivity and Activity Impairment) and cost estimation. Significant changes in the scores of these questionnaires, based on our current work comparing P-HBI remission versus active disease, are the following (all are given in points, except WPAI is percent): SIBDQ 6, SWLS 5, FAD 0.15, COPE dysfunctional 2.5, COPE emotion-focused 0.7, COPE problem-focused 0.6, WPAI time missed 14, WPAI percent impairment 29, WPAI work impairment 28, WPAI activity impairment 30, GSI 0.6, BSI anxiety 0.6, BSI depression 0.6. We did not use the SF-12, EQ-5D, MSPSS, PSS-4 and the FACIT Fatigue Scale in our previous research and will look at reports in the literature and our newly acquired data to determine what are significant improvements.
Before and at the end of each intervention session a short assessment of patient's subjective units of distress (SUDS) will be done, as per Wolpe, Joseph (1969), The Practice of Behavior Therapy, New York: Pergamon Press, and the 4 question Short-Form Perceived Stress Scale, as per Warttig et al, J Health Psychology 2013;18:1617-28.
Correlations of psychological measures with demography, economic status, HBI, immune regulation, telomere shortening, fMRI data, changes in composition of microbiota. Change in biophysical parameters as sleep physical activity \& pulse rate.
To determine whether the intervention is cost-saving or cost-effective, by prospective monitoring of resource use and indirect costs.
To determine whether the intervention can be given effectively using telemedicine with Skype or alternative software.
To study patient acceptability of the intervention, including recruitment and drop-out rate, and the adherence rate to home practice of the stress reduction measure taught.
Expected outcomes
Reduced HBI, improvement of all the psychological measures including both quality-of-life and satisfaction with life, less stress, less fatigue, more use of adaptive coping strategies, with no clear improvements in the control group. Improvement in biophysical parameters as sleep physical activity \& pulse rate.
The research will identify the best form of delivering the interventional therapy and if it is cost-saving or cost-effective.
Confirmation of the reliability of measurements of modification of immune regulation mechanisms and telomere length, grey matter thickness and composition of the microbiota.
Glucocorticoid resistance and related laboratory determinations on patients' leukocytes will add to understanding the biological mechanisms associated with stress-induced pathogenic autoimmunity in the patients in a sex-dependent manner. This will add to our understanding the biological mechanisms associated with stress in Crohn's disease.
Work plan and methodology
Patient recruitment i. Patients: 200 patients being treated at all the participating hospitals (Soroka Medical Center, Rambam Health Campus, Sheba Medical Center, Rabin Medical Center, Shaare Zedek Medical Center), which all have electronic records of large cohorts of patients with Crohn's disease and by advertising through patient support groups and institutions upon approval. The recruitment of patients will be offered in all the hospitals. Preference will be given to patients who have participated in the previous IIRN study and are now participating in the new IIRN studies proposed by the other hospitals, and those patients in higher risk groups (poorer men, female gender, etc.). iv. Patients on a fixed dose of corticosteroids and those who received corticosteroid therapy in last 6 months will present a special sub-group on whom the laboratory studies of cortisol and glucocorticoid resistance may differ significantly from patients not on this treatment, but this will have to be verified by measurements in a small sample to determine the magnitude of the effect before a decision to include or exclude these individuals.
Patients with change of diagnosis in the course of the study period will be excluded from the final analysis. vi. Ethical considerations: This protocol will need approval of the Ethics Committee at all hospitals prior to commencement of patient recruitment and access of patient data at these hospitals. A signed informed consent form will be obtained from each participant.
Assessment of patient status i. Medical status (HBI) and phenotype. No attempt will be made to modify the patients' treatments. ii. Psycho-social self-report questionnaires: demography, economic status, SIBDQ, EQ-5D, SF-12, WPAI, SWLS, FACIT, COPE, FAD, BSI, GSI, FMI, MSPSS, PSS-4, LEQ. iii. Objective outcomes:
HBI, CRP, calprotectin, relevant imaging studies (radiology, endoscopy) biophysical parameters as sleep physical activity \& pulse rate.
Special tests on all or selected sub-sets of patients: immune regulation, telomeres, fMRI, and microbiota.
Biophysical parameters as sleep physical activity \& pulse rate will be monitored in 30 patients by using commercially available smart watches.
Psycho-social interventions i. The sample size calculation is based on α = 0.05, power = 0.8, SD = 14 (data from our current research) in order to achieve a 6-point change in the SIBDQ (the primary endpoint). Thus, the cohort will consist of 172 patients computer-randomized to two groups; 86 patients with mindfulness-based stress reduction, and 86 wait-list controls that will enter the intervention phase after 3 months. In order to allow for a 15% expected drop-out rate, these recruitment numbers may need to be increased to 200 patients. An equal number of women and men will be recruited at each hospital. ii. The group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5. This group will have 4 time points for assessment (see Table, below). iii. Wait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions. The reason for wait-listing is to ensure that there will be a control group to parallel the first 3 months of intervention therapy in the patients getting the therapy from the start. The control group will have the same time points for data assessment as the intervention group. iv. All interventions will be individual sessions. v. Patients will be accessed via internet apps such as Skype. vi. Mindfulness-based stress reduction is to be given by specially trained therapists: These are social workers (PhD or Masters candidate level), who have undergone a training session program provided by relevant researchers of this protocol (including clinicians) as well as invited outside psychologists and psychiatrists with specialization in this field. vii. Psycho-social, medical and biological data will be collected at the measurement points T1, T2, T3 and T4 (see Table) in all patients. fMRI (to be performed at Soroka Medical Center, without use of contrast) and microbiota studies (stool samples) will be performed on a subset of patients.
Health-care cost i. Direct costs: admissions to hospital, surgery, consultations (primary care physicians, specialists, dieticians, social services) investigations and medications, travel costs to medical facilities. ii. Indirect costs: lost workdays, lost productivity, disability payments, travel costs and expenses of escorts.
Immune regulation studies, glucocorticoid resistance in lymphocytes, telomeres i. Blood collections (see Table of events, below) will be performed on consenting patients with Crohn's disease before and after Mindfulness-based stress reduction at 3 time points, as well as in age- and gender-matched consenting healthy volunteer controls (consenting patients without inflammatory diseases attending at the Gastroenterology Department at Soroka Medical Center for screening endoscopies) at one time points. ii. Blood will be drawn immunological and telomere studies.
Immunology: Blood is sampled twice from 60 Crohn's disease and from 60 controls for isolation of serum and peripheral blood mononuclear cell aliquots at enrollment and after Mindfulness-based stress reduction (provided these patients enter a phase of remission). Serum measures will include plasma C-reactive protein (CRP), ACTH, CBG and sex hormones. Similarly, peripheral blood mononuclear cell will undergo functional immune phenotyping of disease-implicated T cell and B cell subsets and assessments of their glucocorticoid resistance. Glucocorticoid signaling experiments will be performed in purified pro-inflammatory lymphocyte subsets found to exhibit glucocorticoid resistance. Results will be correlated with all other measures in this proposal. Controls for these tests will be matched healthy volunteers. The same tests will be carried out in the controls.
Telomere studies in 30 patients with Crohn's disease and 30 controls: by TeloTAGGG™ Telomere Length Assay (Merck). Two blood samples will be needed (see Table of events, below) f. Stool testing - stool samples will be collected at T1 and T2 i. Calprotectin will be measured in the stool at T1 and T2. ii. Microbiota study will be performed on 30 intervention patients and 30 control patients.
fMRI - A non-contrast brain MRI will be performed on 30 intervention and 30 control patients at T1 and T2

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cognitive behavioral mindfulness intervention at entry	Experimental	Behavioral: Cognitive behavioral mindfulness interventionCognitive behavioral mindfulness intervention at entry
Cognitive behavioral mindfulness intervention after 3 months	Active comparator	Behavioral: Cognitive behavioral mindfulness intervention after 3-month wait listCognitive behavioral mindfulness intervention after 3 months of wait list

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Willingness to participate and commit to a one-year process
Age 18-75 years
Hebrew-speaking
Proven diagnosis of mild/moderate Crohn's disease
At least 3 months post-diagnosis

Key exclusion criteria (8 listed)

Crohn's disease that is severe (HBI >16) or in remission (HBI<5)
Ulcerative colitis, IBD unclassified
Planned surgery or surgery in last 6 months
Psychiatric disease
Psychotropic medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive behavioral mindfulness interventionThe group that receives mindfulness-based stress reduction at their entry into the study will have 7 sequential sessions during 3 months, and later have a booster session in month 5	Behavioural	Cognitive behavioral mindfulness intervention at entry
Cognitive behavioral mindfulness intervention after 3-month wait listWait-list control patients will get no intervention at the start of the study and instead will be contacted by study personal 7 times to care for the patient in order to control for the 7 sessions performed in the intervention group. After three months they will be offered mindfulness-based stress reduction as 8 sequential sessions.	Behavioural	Cognitive behavioral mindfulness intervention after 3 months

Primary outcome

Change in Crohn's disease specific health-related quality of life
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Range: 10-70; Higher score indicates better quality of life
Change in general health profile
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Measured by the Short Form-12 (SF-12); 0-100; Higher scores indicate better quality of life
Change in utility weights
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Measured by the EuroQoL (EQ-5D-3L); 0-1; Higher scores indicate higher and better utility weights

11 secondary outcomes

Social support
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Stress, anxiety and depression
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Perceived stress
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Satisfaction with life
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Fatigue
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Pain reduction
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Coping with disease
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Performance at work
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Resource utilization and healthcare costs
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Mindfulness
Time frame: Measured at baseline, 3-months, 6-months, 12-months
Family Support
Time frame: Measured at baseline, 3-months, 6-months, 12-months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Derived from this study: PubMed 40095500Goren G, Schwartz D, Friger M, Sergienko R, Monsonego A, Slonim-Nevo V, Greenberg D, Odes S, Sarid O. Gender Differences in Coping Strategies and Life Satisfaction Following Cognitive-Behavioral and Mindfulness-Based Intervention for Crohn's Disease: A Randomized Controlled Trial. J Clin Med. 2025 Feb 26;14(5):1569. doi: 10.3390/jcm14051569.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ganit Goren, MA study director

Ben-Gurion University of the Negev

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Crohn's disease specific health-related quality of life (time frame: Measured at baseline, 3-months, 6-months, 12-months). The study lists 3 primary outcomes in all. 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 NCT05085925, which also lists 2 linked publications.

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 20 Oct 2021.