A Study Comparing the Addition of Structured Psychosocial Care versus Standard of Care to the Treatment of Patients with Inflammatory Bowel Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007218
Sponsor Protocol Number: 16-007218
About this study
The purpose of the study is to compare the addition of structured psychosocial care versus standard medical care alone for the treatment of adult patients who have inflammatory bowel disease
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Written informed consent must be obtained and documented
- Males or females
- Between ages of 18 and 75 years
- Documented diagnosis of CD or UC
- Hospital Anxiety and Depression Score (HADS) of 10 – 20
- Ability to participate fully in all aspects of clinical trial
Exclusion Criteria
- Hospital Anxiety and Depression Score (HADS) of less than 10 or greater than
- Serious underlying psychiatric disorder such as schizophrenia or bipolar disorder
- History of illegal drug abuse (excluding marijuana) or alcohol abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures
- Serious medical comorbidity which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Sunanda Kane, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available