SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

NCT06002074 | Terminated

• 1 other identifier: 23-004024
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Stress

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)

  Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.

  Baseline, approximately 20 weeks

Study Arms (1)

Stress management and resilience training

EXPERIMENTAL

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.

Behavioral: Stress Management and Resilience Training Program

Interventions

Stress Management and Resilience Training Program 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.

Also known as: SMART

Stress management and resilience training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Corticosteroids in the previous 3 months
• Elicit substance use (including medical marijuana)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Victor G. Chedid, M.D., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: September 28, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)