SMART Program in Irritable Bowel Syndrome (IBS)

NCT03454386 | Completed

• 1 other identifier: IRB#18-000235
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome (IBS); Stress; Resilience; Stress Management and Resilience Training Program (SMART)

Outcome Measures

Primary Outcomes (1)

• Change in perceived stress score from baseline

  Validated questionnaire with 10 questions regarding respondents stress levels

  Week 12 (end of the SMART program)

Secondary Outcomes (12)

• Change in perceived stress score from baseline

  Week 4

• IBS symptom severity responder rate

  Week 4, week 12

• IBS related quality of life responder rate

  Week 4, week 12

• Change from baseline in resilience scores as measured by the Brief Resilience scale

  Week 4, week 12

• Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale

  Week 4, week 12

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Stress Management and Resilience Training Program This group will be initially enrolled in the program.

Behavioral: Stress Management and Resilience Training Program

Control

OTHER

Self-Management Stress Reduction Program This group will be placed in a self-management stress reduction program. During this time these participants will be given a popular stress reduction book to read over 12 weeks. They will complete questionnaires at weeks 4 and 12. After the 12 weeks, this group will be enrolled in the online SMART program and complete assessments at week 24 (upon completion of the program.

Behavioral: Self-Management Stress Reduction Program

Interventions

Stress Management and Resilience Training Program BEHAVIORAL

This 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.

Also known as: SMART Program

Active Treatment

Self-Management Stress Reduction Program BEHAVIORAL

Program 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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those with a diagnosis of IBS based on the Rome IV diagnostic criteria (recurrent abdominal pain at least once per week in the last 3 months associated with 2 of the following: related to defecation, associated with a change in stool frequency, associated with a change in stool form. Symptoms must have started 6 months prior to presentation)
• Between the ages of 18 and 70
• English speaking
• Are able to provide written, informed consent
• At least moderate IBS symptoms (based on an IBS symptom severity scale score \[IBS-SSS\] of 175 or higher)
• At least moderate levels of perceived stress (based on a perceived stress score of 14 or higher
• If receiving pharmacologic therapy for IBS, they must be on a stable dose for 30 days prior to enrollment

You may not qualify if:

• History of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease
• History of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal \>6 months ago)
• Poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia
• Currently receiving, or have received in the last 6 months, other stress reduction therapies such as mindfulness based stress reduction, meditation
• Excessive alcohol intake (up to 1 drink per day for females and 2 drinks per day for males)
• Illicit substance use
• High dose opiate use
• Pregnancy
• Non-English speaking
• Inability to provide written informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Lin Chang, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, G. Oppenheimer Center for Neurobiology of Stress and Resilience, Vatche and Tamar Manoukian Division of Digestive Diseases

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: July 1, 2018
• Primary Completion: November 7, 2019
• Study Completion: February 2, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

US (1)