Smartphone Training for Attention Regulation for IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

Smartphone Stress Management Training for Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083091
• Other study ID #: 1R01DK128114-01
• Secondary ID: 1R01DK128114-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Carnegie Mellon University
• Contact: J. David Creswell, Ph.D.
• Phone: 412-268-9182
• Email: creswell[@]cmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=325), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS. We will also conduct a sub-study that will include completion of a cold-water challenge performance task to test individuals' distress tolerance.

Description:

All assessments and patient interactions have been designed with COVID-19 uncertainties in mind: the investigators can maintain social distancing and use masks during the two in-person visits, and much of the study, including the follow-up session, is conducted remotely.

Baseline Screening and Assessment. Each participant will come to the Health and Human Performance laboratory at CMU for a baseline assessment appointment. They will be apprised of the study aims and approach, provide written informed consent, and complete a brief in-person screening evaluation for study eligibility. Eligible participants will complete a baseline survey assessment (including measures such as IBS illness severity, IBS quality of life, demographics and health measures) and learn how to complete the EMA assessments on data-enabled smartphones. The EMA smartphone assessments will consist of three types of momentary experience data over a period of seven consecutive days following the baseline appointment: (1) participants will be quasi-randomly sampled 3 times per day during waking hours to assess stress and IBS symptoms; (2) participants will be asked to complete event-driven momentary assessments of distress and IBS symptoms after bowel movements; and (3) participants will be asked to complete an event-based assessment after completing each intervention lesson. The investigators will implement an easy-to-use smartphone-enabled EMA sampling program that is downloaded onto each of the phones provided to participants for the duration of the study. Participants will be instructed to complete each EMA assessment as soon as they are beeped. Additionally, participants will be given instructions on how to provide a baseline stool sample for microbiome analysis.

Intervention. Participants will be randomized to either MA-MBI, MO-MBI, or Coping Control (CC) using a 2:2:1 randomization sequence (i.e., for every five individuals randomized, 1 will be assigned to CC). Participants will remain blind to the type of intervention program they are receiving until post-study debriefing, to minimize potential expectancies. The MA-MBI program is a Mindfulness-Based Intervention (MBI). The instructed meditation techniques enable participants to (a) monitor their present-moment body experience while (b) accepting each experience. The MO-MBI program is structurally matched to the MA-MBI program, with no instruction on acceptance. The program instructs participants to concentrate on and (a) monitor physical and emotional body experience during each meditation practice. The Coping Control (CC) program, also matched to the MBI programs, includes no monitoring or acceptance instruction and instead focuses on coping effectiveness strategies. Participants are instructed in 3 skills: (a) thoughtful reflection; (b) reappraisal and reframing past and anticipated stressful events; and (c) problem solving, such as analyzing and solving personal problems. Each intervention begins with the same 5-minute introductory video and involves the completion of one 20-minute audio-guided lesson plus daily life homework practice (3-10 minutes) each day for 14 days. Lessons train specific techniques through didactic explanation and guided practices. After each lesson, participants will complete event-based assessments of stress and IBS distress. On Days 3 and 9 of the intervention program, study staff will contact participants by phone to answer training-specific questions, address difficulties, and encourage program adherence.

Post-Treatment Assessment. Participants in all three conditions will be asked to complete a week of EMA sampling in the week following the completion of the intervention programs, identical in form to their baseline EMA week. They will then come back into the lab for a post-intervention assessment of the same measures used during the baseline assessment, as well as to provide a second stool sample.

2-Month Follow-Up Assessment. Two months after the intervention, participants will complete a final week of EMA sampling. They will then be scheduled to complete a final assessment remotely, where they will complete the same trial outcomes assessment battery as they did at baseline and post-intervention. Additionally, participants will be asked to complete a treatment program evaluation survey measure at this time. After completing the study measures at the 2-month follow-up assessment, participants will be debriefed on the study aims and thanked for their participation.

CGI Assessment. A subset of participants (n=10-15) will be randomly selected to complete the Clinical Global Impressions Improvement Scale (CGI-I) at three time points - shortly after baseline, post-treatment, and at a 2-month follow-up. This assessment will be conducted by our Co-Investigator, Dr. David Levinthal. The CGI-I will incorporate baseline severity of IBS symptoms and the degree of clinical change relative to that baseline. Dr. Levinthal will provide these ratings of the patient's change in IBS symptoms (1=substantially improved to 7=substantially worse) at post-treatment and 2-month follow-up compared to baseline. These assessments will consist of open-ended questions related to the participant's IBS symptoms and the assessment will be based on a scale similar to Table 2 of the CGI article uploaded under Supporting Documents. The assessments will occur over Zoom or over the phone, and no recordings, neither audio nor visual, will be made. Dr. Levinthal will also be blind to the patient's treatment condition. Data collected from these clinical interviews will only be linked to the participant through study ID number, and Dr. Levinthal will complete the assessments over a secure web-based platform such as Qualtrics. The study team will provide Dr. Levinthal the contact information of the randomly chosen participant so that he can reach out to the participant to schedule these assessments. The team will then provide him the study ID number separately, ensuring that the contact information and study ID number are never linked together.

Cold Challenge Sub-Study. For participants who indicated that they would be willing to participate in the cold-challenge sub-study, they will be shown an instructional video outlining the cold-pressor task (as specified below). Once the participant submerges their left hand in the water, the experimenter will start a stopwatch and will ask the participant to rate their sensation intensity and distress verbally by showing them the visual chart. This will occur every 30 seconds up to 5 minutes, which at that point the participant will be asked to remove their hand. Once the participant's hand is on the towel, the experimenter will ask them to rate their sensation intensity and distress immediately and then again, every 30 seconds up to 2 minutes. They will then be allowed to move and dry their hand. To help the participant warm their hand up, the experimenter will recommend them to use a few strategies. These strategies include hand exercises (e.g., moving the hand in circles, clenching and releasing the hand), massaging the hand, and placing the hand under an armpit or a warm area of the body.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rome IV IBS diagnosis

• Indicate moderate to high levels of psychological distress over the past two weeks (composite score >5 on the Patient Health Questionnaire-4)

• Willingness to provide assessments of bowel symptoms and complete study measures (including smartphone assessments)

• Willingness/availability to be randomized and participate in all study activities

Exclusion Criteria:

• Non-English speaking

• Report a new diagnosis of a (non-acute) medical or psychiatric condition requiring treatment within the last 3 months

• Have a history of diagnosed IBD or gastrointestinal malignancies.

• Begun any new treatments for IBS in the four weeks prior to baseline

• Currently pregnant

• Had a colonoscopy within 2 weeks of enrolling in the study or within the first 4 weeks of study procedures

• CGI Interview Only: Is a patient of Dr. David Levinthal

Cold Challenge Sub-study. Exclusion criteria: an existing pain condition, Reynaud's disease, history of heart/cardiovascular disease, high blood pressure, recent injuries, circulatory disorders, current or past frostbite, open cuts, or sores in both hands, a history of seizures, asthma, sickle cell disease or trait, cerebrovascular disease, a recent stroke or heart attack, or anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the study, pregnant or might be pregnant, and/or have a tendency/history of fainting after vaccines, shots, and/or blood draws. Participants will be excluded if they have taken anxiolytic medication (e.g., Ativan, Xanax) or pain medication (e.g., aspirin) taken in the 2 hours prior to the lab session. Participants who report viral illness (e.g., cold) and/or negative physical health symptoms (e.g., stomachache, nausea, fever, dehydration, hunger, sleep deprivation) before the start of the session will also be excluded.

As they will be visiting our laboratory on campus, participants will now be required to show proof of COVID-19 vaccination to participate in the study. Participants must also show proof of a booster shot, if they do not have one, they will be asked to wear a mask at in-person sessions to participate. Moving forward, we will continue to follow CMU COVID protocols.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Mindfulness and Attention Training
Guided mindfulness meditation with attention monitoring and acceptance skills training
• Mindfulness training
Guided mindfulness meditation, no attention monitoring or acceptance skills training
• Coping Condition
Guided training focused on coping effectiveness strategies, no monitoring or acceptance instruction

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Carnegie Mellon University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Reported Diet	Evaluated using a 7-day focused food frequency questionnaire based on established questionnaires used in previous NIH dietary trials with a special focus on FODMAP and probiotics consumption	Change from baseline to 1-week post-intervention and 2-month follow-up
Other	Change in Self-Reported Treatment Expectancies	Evaluated using The 6-item Credibility-Expectancy Questionnaire, with a higher total score indicating greater treatment expectancy and credibility of the participant.	Change from baseline to 1-week post-intervention
Primary	Change in IBS Symptom Severity	The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), queries patients on the severity and occurrence of abdominal pain, bloating, tightness, and bowel habits, and IBS life interference over the previous ten days. Scores are totaled (0-500 range) to obtain a composite IBS severity score, with the scale demonstrating acceptable clinical sensitivity to change (50 point changes indicate clinical improvement).	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	IBS Symptom Improvement	The Clinical Global Impressions Scale (CGI-I), a one-item 7-point measure, evaluates improvement in overall clinical condition (1= very much improved since the initiation of the treatment to 7=very much worse since the initiation of the treatment).	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Self-Reported Symptom-Related Psychological Outcomes	The Brief Symptom Inventory 18-item is a self-report measure used to assess psychological problems in adults. The scale asks patients to rate how bothered they were by symptoms on a 5-point scale (1=not at all bothered to 5= extremely bothered). Therefore, total scores can range from 18 to 90, with a higher score indicating greater distress.	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Self-Reported IBS Quality of Life	The Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a 34-item scale that measures quality of life specific to IBS. The scores are transformed to a 0-100 scale, with higher scores corresponding to better IBS specific quality of life.	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Microbiome Biology	Gut microbiome diversity evaluated using 16S rRNA gene sequencing for stool samples	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Self-Reported Perceptions of Stress	Evaluated using Ecological Momentary Assessment using the items "Right now, how much stress are you experiencing or feeling?" (1=no stress to 7 = extremely severe stress); "Since the last survey, did you experience any feelings of stress?" (yes/no).	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Self-Reported Perceptions of IBS Distress	Evaluated using Ecological Momentary Assessment using the items "Right now, how severe are your IBS symptoms right now? (1=no symptoms to 7=extremely severe symptoms); "Right now, how much are your IBS symptoms interfering with your life right now?" (1=not at all to 7=extremely); "Right now, my IBS symptoms are causing me distress" (1=no distress to 7= extremely severe distress).	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Change in Self-Reported Perceptions of IBS Distress During Bowel Movements	Evaluated using Event-Triggered Ecological Momentary Assessment. Measures their perceptions of distress in the minutes leading up to sitting on the toilet ("how distressed did you feel in the ten minutes leading up to sitting on the toilet? 1=not at all distressed to 7= extremely distressed) and during the bowel movement attempt ("how distressed did you feel while sitting on the toilet? 1=not at all distressed to 7= extremely distressed).	Change from baseline to 1-week post-intervention and 2-month follow-up
Primary	Pain Tolerance following Cold Pressor Task	Evaluated by length of time (in minutes, seconds, and milliseconds) participant's hand is under water, where the maximum amount of time is 5 minutes, 0 seconds, 0 milliseconds. Measures the degree of pain/discomfort that can be withstood by the participants following completion of their assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.	Differences across all three conditions collected at post-intervention
Primary	Sensation Intensity Rating following Cold Pressor Task	Evaluated using a Likert-type scale on a single item ("how intense are the sensations for you at the moment?", 1=no sensations, 10=most intense sensations) every 30 seconds, measures the degree of intense sensations felt following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.	Differences across all three conditions collected at post-intervention
Primary	Distress Rating following Cold Pressor Task	Evaluated using a Likert-type scale on a single item ("how distressed are you by the sensations at the moment?", 1=no distress, 10=worse distress) every 30 seconds, measures the degree of distress tolerance that can be withstood by participants following completion of participant's assigned intervention condition. Differences will be analyzed across the three different arms (i.e., MA, MO, and CC) of the study.	Differences across all three conditions collected at post-intervention
Secondary	Change in Self-Reported Perceived Stress	The 10-item Perceived Stress Scale is a self-reported assessment of perceptions of stress over the past month. Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Depressive Symptomatology	Evaluated using the 9-Item Patient Health Questionnaire (PHQ-9), which asks how often one has been bothered by 9 problems (0= not at all to 3= nearly every day), with a higher total score indicating more severe depressive symptomatology.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Mindfulness	Evaluated using the The Five Facet Mindfulness Questionnaire, a 24-item scale measuring mindfulness. Each item is rated on a scale from 1=never or very rarely true to 5= very often or always true, with a higher total score indicating greater mindfulness tendencies.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Loneliness	The UCLA Loneliness scale will be used to measure subjective feelings of loneliness and social isolation. A total score that ranges from 20 to 80 is calculated by summing the score of each item. A higher total score signifies increased feelings of loneliness.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Distress Tolerance	Evaluated using the Distress Tolerance Scale (DTS), which asks participants to describe their beliefs about feeling distressed or upset in 15-item. Each item is scored as 1=strongly agree to 5= strongly disagree, and higher total scores correspond to greater distress tolerance.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Perceived Partner Responsiveness	Change in perceived partner responsiveness will be measured using the Perceived Responsiveness and Insensitivity (PRI) Scale, a 4-item scale, in which each item is rated from 0= not at all to 5= completely, with a higher total score corresponding to more understanding and validation.	Change from baseline to 1-week post-intervention and 2-month follow-up
Secondary	Change in Self-Reported Sensitivity and Attention to Interoceptive Signals	Evaluated using the 17-item Interoceptive Sensitivity and Attention Questionnaire, in which each item is rated from 1= strongly disagree to 5= strongly agree, with a higher total score reflecting more sensitivity and attention to interoceptive signals.	Change from baseline to 1-week post-intervention
Secondary	Change in Gastrointestinal Symptom-Specific Anxiety	Evaluated using the 15-item Visceral Sensitivity Index, in which each item is rated from 1= strongly agree to 6= strongly disagree.	Change from baseline to 1-week post-intervention