SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

NCT ID: NCT06002074

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-09-27

Brief Summary

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This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Stress management and resilience training

Subjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training.

Group Type EXPERIMENTAL

Stress Management and Resilience Training Program

Intervention Type BEHAVIORAL

One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.

Interventions

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Stress Management and Resilience Training Program

One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.

Intervention Type BEHAVIORAL

Other Intervention Names

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SMART

Eligibility Criteria

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Inclusion Criteria

* History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease.
* Access to internet/device such as smart phone, tablet, or computer
* Patient reports stress as a trigger to their GI symptoms

Exclusion Criteria

* Corticosteroids in the previous 3 months
* Elicit substance use (including medical marijuana)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Victor Chedid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor G. Chedid, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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23-004024

Identifier Type: -

Identifier Source: org_study_id

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