SMART Program in Irritable Bowel Syndrome (IBS)
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|ClinicalTrials.gov Identifier: NCT03454386|
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Behavioral: Stress Management and Resilience Training Program Behavioral: Self-Management Stress Reduction Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Active Comparator: Active Treatment
Stress Management and Resilience Training Program
This group will be initially enrolled in the program.
Behavioral: Stress Management and Resilience Training Program
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 Name: SMART Program
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
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.
- Change in perceived stress score from baseline [ Time Frame: Week 12 (end of the SMART program) ]Validated questionnaire with 10 questions regarding respondents stress levels
- Change in perceived stress score from baseline [ Time Frame: Week 4 ]Validated questionnaire with 10 questions regarding respondents stress levels
- IBS symptom severity responder rate [ 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.
- IBS related quality of life responder rate [ 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
- Change from baseline in resilience scores as measured by the Brief Resilience scale [ Time Frame: Week 4, week 12 ]The Brief Resilience scale is a 6 question validated questionnaire
- Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale [ Time Frame: Week 4, week 12 ]The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
- Change from baseline in adaptive resilience score [ Time Frame: Week 4, week 12 ]A validated questionnaire to measure adaptive resilience will be used
- Change in gratitude scores from baseline [ Time Frame: Week 4, week 12 ]Gratitude will be measured using a validated questionnaire.
- Change in mindfulness scores from baseline [ Time Frame: Week 4, week 12 ]Mindfulness will be measured using the validated five factor mindfulness questionnaire
- Change in patient satisfaction from baseline [ 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.
- Change in anxiety symptoms from baseline [ Time Frame: Week 4, week 12 ]Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
- Change in gastrointestinal symptom related anxiety from baseline [ Time Frame: Week 4, week 12 ]Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
- Change in somatic symptom severity from baseline [ Time Frame: Week 4, week 12 ]Somatic symptom severity will be measured using the validated patient health questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454386
|Contact: Nafeesa Islamemail@example.com|
|Contact: Lin Chang, MDfirstname.lastname@example.org|
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: Nafeesa Islam 310-206-1656 email@example.com|
|Principal Investigator: Lin Chang, MD|
|Principal Investigator:||Lin Chang, MD||University of California, Los Angeles|