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

NCT05085925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2021-10-20

No results posted yet for this study

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.

Conditions

  • Crohn's Disease Colon

Interventions

BEHAVIORAL

Cognitive behavioral mindfulness intervention

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

BEHAVIORAL

Cognitive behavioral mindfulness intervention after 3-month wait list

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.

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Ganit Goren, MA · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2020-06-08
Completion
2021-07-16

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085925 on ClinicalTrials.gov