Clinical Trials Directory

Trials / Completed

CompletedNCT03454386

SMART Program in Irritable Bowel Syndrome (IBS)

Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This is a pilot study to determine the efficacy of the Stress Management and Resilience Training (SMART) program in improving gastrointestinal and psychological symptoms, health-related quality of life, and satisfaction of care in patients with irritable bowel syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The other half will be placed in a self-management stress reduction program where they will read a popular stress reduction book over 12 weeks. Then they will have access to participate in the online SMART program.

Detailed description

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain related to defecation and associated with changes in stool frequency and/or form. IBS is a stress sensitive disorder and its severity has been shown to be moderated by both acute and chronic stress. Furthermore, resilience, which is defined as the ability to positively adapt and thrive in the presence of stressors and adversity, has been shown to be lower in those with IBS and associated with more severe symptoms. Therapies aimed at stress reduction in IBS have been found to be effective in the management of IBS. To our knowledge, there are no reports in the literature of a therapy to target resilience in the IBS patient population. The Stress Management and Resilience Training (SMART) program was developed by Dr. A. Sood at the Mayo clinic to reduce stress, decrease symptoms related to stress and enhance resiliency. This is accomplished by targeting human attention and interpretation of events, people and the world. Furthermore, methods to strengthen the skills of gratitude, compassion, acceptance, forgiveness and understanding of a higher meaning are taught. Previous studies have demonstrated that this program can improve stress, anxiety, resilience and quality of life of participants.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStress Management and Resilience Training ProgramThis program targets attention and interpretation of events, people and the world through the skills of gratitude, compassion, acceptance, forgiveness and understanding of a higher meaning. The program involves two phases. The 4 week "training phase" begins with a group session that discusses the practices that can be used to enhance awareness and engagement through the principles listed above. Participants will receive twice weekly emails with videos that described a different practice for participants to use in their daily lives. The second phase is the "sustain phase" that is 8 weeks in duration. Participants are expected to continue using the daily practices learned during the training phase. Weekly emails will be sent with ways to incorporate these practices into their daily lives.
BEHAVIORALSelf-Management Stress Reduction ProgramProgram participants will be given a popular stress reduction book to read over a 12 week period. Upon completion of this, they will be enrolled in the online SMART program for 12 weeks.

Timeline

Start date
2018-07-01
Primary completion
2019-11-07
Completion
2020-02-02
First posted
2018-03-05
Last updated
2020-06-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03454386. Inclusion in this directory is not an endorsement.