An interventional study of Stress Management and Resilience Training Program and Self-Management Stress Reduction Program in Irritable Bowel Syndrome, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-01.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Stress Management and Resilience Training Program This group will be initially enrolled in the program.
Behavioral: Stress Management and Resilience Training 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
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
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
Validated questionnaire with 10 questions regarding respondents stress levels
Time frame: Week 12 (end of the SMART program)
Change in perceived stress score from baseline
Validated questionnaire with 10 questions regarding respondents stress levels
Time frame: Week 4
IBS symptom severity responder rate
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 responder rate
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
Change from baseline in resilience scores as measured by the Brief Resilience scale
The Brief Resilience scale is a 6 question validated questionnaire
Time frame: Week 4, week 12
Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale
The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
Time frame: Week 4, week 12
Change from baseline in adaptive resilience score
A validated questionnaire to measure adaptive resilience will be used
Time frame: Week 4, week 12
Change in gratitude scores from baseline
Gratitude will be measured using a validated questionnaire.
Time frame: Week 4, week 12
Change in mindfulness scores from baseline
Mindfulness will be measured using the validated five factor mindfulness questionnaire
Time frame: Week 4, week 12
Change in patient satisfaction from baseline
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
Change in anxiety symptoms from baseline
Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Time frame: Week 4, week 12
Change in gastrointestinal symptom related anxiety from baseline
Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Time frame: Week 4, week 12
Change in somatic symptom severity from baseline
Somatic symptom severity will be measured using the validated patient health questionnaire
Time frame: Week 4, week 12
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles