UCLA
Los Angeles, California, 90095, United States
NCT Number: NCT03454386
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: SMART Program
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.
Time frame: Week 12 (end of the SMART program)
Validated questionnaire with 10 questions regarding respondents stress levels
Time frame: Week 4
Validated questionnaire with 10 questions regarding respondents stress levels
Time frame: Week 4, week 12
IBS symptom severity will be measured using the validated IBS symptom severity score. A participant will be consider a responder if they have a 50 point reduction in their baseline score.
Time frame: Week 4, week 12
IBS related quality of life will be measure using a validated questionnaire. A participant is considered a responder if there is a 14 point improvement in their baseline score
Time frame: Week 4, week 12
The Brief Resilience scale is a 6 question validated questionnaire
Time frame: Week 4, week 12
The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
Time frame: Week 4, week 12
A validated questionnaire to measure adaptive resilience will be used
Time frame: Week 4, week 12
Gratitude will be measured using a validated questionnaire.
Time frame: Week 4, week 12
Mindfulness will be measured using the validated five factor mindfulness questionnaire
Time frame: Week 4, week 12
The measurement of patient satisfaction will be adapted from the patient global satisfaction scale from the Hospital Consumer Assessment of Healthcare Providers and Systems.
Time frame: Week 4, week 12
Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Time frame: Week 4, week 12
Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Time frame: Week 4, week 12
Somatic symptom severity will be measured using the validated patient health questionnaire
University of California, Los Angeles
Other
Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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