Mindfulness-Based Stress-Reduction in Patients With Crohn's Disease
Randomized Intervention Study of Mindfulness-Based Stress-Reduction to Improve the Quality of Life and Immune Regulation in Patients With Crohn's Disease
2 other identifiers
interventional
142
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2018
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedOctober 20, 2021
October 1, 2021
2 years
February 18, 2020
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 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 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 at baseline, 3-months, 6-months, 12-months
Secondary Outcomes (11)
Social support
Measured at baseline, 3-months, 6-months, 12-months
Stress, anxiety and depression
Measured at baseline, 3-months, 6-months, 12-months
Perceived stress
Measured at baseline, 3-months, 6-months, 12-months
Satisfaction with life
Measured at baseline, 3-months, 6-months, 12-months
Fatigue
Measured at baseline, 3-months, 6-months, 12-months
- +6 more secondary outcomes
Study Arms (2)
Cognitive behavioral mindfulness intervention at entry
EXPERIMENTALCognitive behavioral mindfulness intervention at entry
Cognitive behavioral mindfulness intervention after 3 months
ACTIVE COMPARATORCognitive behavioral mindfulness intervention after 3 months of wait list
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soroka University Medical Center
Beersheba, Israel
Related Publications (2)
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.
PMID: 40243391DERIVEDGoren 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.
PMID: 40095500DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ganit Goren, MA
Ben-Gurion University of the Negev
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician, Department of Gastroenterology and Hepatology
Study Record Dates
First Submitted
February 18, 2020
First Posted
October 20, 2021
Study Start
June 13, 2018
Primary Completion
June 8, 2020
Study Completion
July 16, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share