Irritable Bowel SyndromeNCT05083091
Smartphone Training for Attention Regulation for IBS
A study testing Mindfulness and Attention Training, Mindfulness training and Coping Condition in people with Irritable Bowel Syndrome, run by Carnegie Mellon University at 1 site in United States.
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=360), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Mindfulness and Attention Training, Mindfulness training and Coping Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rome IV IBS diagnosis
- Indicate moderate to high levels of psychological distress over the past two weeks (composite score >=4 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Smartphone Stress Management Training for Irritable Bowel Syndrome
In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=360), 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.
Read the detailed 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. Individuals interested in participating will complete a brief online screening survey, and final study determination will be made by the recruitment project manager. For special cases where eligibility is in doubt or uncertain, members of the investigative team will be contacted to make a final determination. Each eligible 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, and provide written informed consent. 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, IBS symptoms, affect, coping, and mindful acceptance; (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 a daily diary assessment to assess IBS symptoms, IBS distress, social interactions, and loneliness and mood throughout the day. 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 within the allotted 60 minute window for quasi-random daily surveys, and within the allotted 3 hour window for daily dairy assessments. 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=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.
During the trial, the dataset will be locked and maintained by the independent unblinded study statistician and the unblinded project manager(s). The statistician will remain unblind to participant study condition during data collection and analysis (the unblinded statistician and unblinded project manager(s) will maintain an electronic file on a secure online database that links the study statistician randomization codes (1,2,3) to condition codes (A,B,C) that reference study conditions).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Mindfulness and Attention Training, Mindfulness training, Coping Condition
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Attention TrainingBehavioural
Also called MA-MBI
Guided mindfulness meditation with attention monitoring and acceptance skills training
Mindfulness trainingBehavioural
Also called MO-MBI
Guided mindfulness meditation, no attention monitoring or acceptance skills training
Coping ConditionBehavioural
Also called CC
Guided training focused on coping effectiveness strategies, no monitoring or acceptance instruction
| Study group | Role | What they receive |
|---|---|---|
| Monitor & Accept (MA-MBI) | Active comparator | 14-day smartphone based mindfulness meditation attention monitoring and acceptance skills training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. Receives: Behavioral: Mindfulness and Attention Training |
| Monitor Only (MO-MBI) | Active comparator | 14-day smartphone based mindfulness meditation training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. Receives: Behavioral: Mindfulness training |
| Coping Condition (CC) | Active comparator | 14-day smartphone based training intervention focused on coping strategies consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. Receives: Behavioral: Coping Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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).
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Microbiome Biology
Gut microbiome diversity evaluated using shotgun metagenomic sequencing for stool samples
Measured: Change from baseline to 1-week post-intervention
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).
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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).
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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).
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Differences across all three conditions collected at post-intervention
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.
Measured: Differences across all three conditions collected at post-intervention
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.
Measured: Differences across all three conditions collected at post-intervention
Secondary outcomes (8)
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention and 2-month follow-up
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.
Measured: Change from baseline to 1-week post-intervention
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.
Measured: Change from baseline to 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Mar 2022
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, David Creswell, Carnegie Mellon University
- Investigators
- J. David Creswell, Ph.D., Principal investigator, Carnegie Mellon UniversityEmily K Lindsay, Ph.D., Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083091
- Sponsor's protocol ID
- 1R01DK128114-01
- Other IDs
- 1R01DK128114-01
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share data associated with self-reports (e.g. demographics, stress levels) and adherence by depositing the data at the Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository. All data and documentation will be de-identified and will be consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards. This data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report. The study team agrees to deposit and maintain the phenotypic data and secondary analysis of data (if any) at ICPSR. The repository has data access policies and procedures consistent with NIH data sharing policies.
Publications
Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Adv Data. 2004 May 27;(343):1-19.
PubMed 15188733Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
PubMed 18799450Nyklicek I, Mommersteeg PM, Van Beugen S, Ramakers C, Van Boxtel GJ. Mindfulness-based stress reduction and physiological activity during acute stress: a randomized controlled trial. Health Psychol. 2013 Oct;32(10):1110-3. doi: 10.1037/a0032200. Epub 2013 Mar 25.
PubMed 23527521Creswell JD, Pacilio LE, Lindsay EK, Brown KW. Brief mindfulness meditation training alters psychological and neuroendocrine responses to social evaluative stress. Psychoneuroendocrinology. 2014 Jun;44:1-12. doi: 10.1016/j.psyneuen.2014.02.007. Epub 2014 Feb 23.
PubMed 24767614Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.
PubMed 19853530Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
PubMed 21471390Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4.
PubMed 18835662Gaylord SA, Palsson OS, Garland EL, Faurot KR, Coble RS, Mann JD, Frey W, Leniek K, Whitehead WE. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. Am J Gastroenterol. 2011 Sep;106(9):1678-88. doi: 10.1038/ajg.2011.184. Epub 2011 Jun 21.
PubMed 21691341Garland EL, Gaylord SA, Palsson O, Faurot K, Douglas Mann J, Whitehead WE. Therapeutic mechanisms of a mindfulness-based treatment for IBS: effects on visceral sensitivity, catastrophizing, and affective processing of pain sensations. J Behav Med. 2012 Dec;35(6):591-602. doi: 10.1007/s10865-011-9391-z. Epub 2011 Dec 8.
PubMed 22161025Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.
PubMed 20362976Zernicke KA, Campbell TS, Blustein PK, Fung TS, Johnson JA, Bacon SL, Carlson LE. Mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial. Int J Behav Med. 2013 Sep;20(3):385-96. doi: 10.1007/s12529-012-9241-6.
PubMed 22618308Aucoin M, Lalonde-Parsi MJ, Cooley K. Mindfulness-based therapies in the treatment of functional gastrointestinal disorders: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:140724. doi: 10.1155/2014/140724. Epub 2014 Sep 11.
PubMed 25295066Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
PubMed 27687118Creswell JD, Lindsay EK, Villalba DK, Chin B. Mindfulness Training and Physical Health: Mechanisms and Outcomes. Psychosom Med. 2019 Apr;81(3):224-232. doi: 10.1097/PSY.0000000000000675.
PubMed 30806634Creswell JD, Taren AA, Lindsay EK, Greco CM, Gianaros PJ, Fairgrieve A, Marsland AL, Brown KW, Way BM, Rosen RK, Ferris JL. Alterations in Resting-State Functional Connectivity Link Mindfulness Meditation With Reduced Interleukin-6: A Randomized Controlled Trial. Biol Psychiatry. 2016 Jul 1;80(1):53-61. doi: 10.1016/j.biopsych.2016.01.008. Epub 2016 Jan 29.
PubMed 27021514
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Stress Management Training for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05083091
- Acronym / sponsor ID
- 1R01DK128114-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=360), 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.
Detailed 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. Individuals interested in participating will complete a brief online screening survey, and final study determination will be made by the recruitment project manager. For special cases where eligibility is in doubt or uncertain, members of the investigative team will be contacted to make a final determination. Each eligible 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, and provide written informed consent. 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, IBS symptoms, affect, coping, and mindful acceptance; (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 a daily diary assessment to assess IBS symptoms, IBS distress, social interactions, and loneliness and mood throughout the day. 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 within the allotted 60 minute window for quasi-random daily surveys, and within the allotted 3 hour window for daily dairy assessments. 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=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.
During the trial, the dataset will be locked and maintained by the independent unblinded study statistician and the unblinded project manager(s). The statistician will remain unblind to participant study condition during data collection and analysis (the unblinded statistician and unblinded project manager(s) will maintain an electronic file on a secure online database that links the study statistician randomization codes (1,2,3) to condition codes (A,B,C) that reference study conditions).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monitor & Accept (MA-MBI) | Active comparator | Behavioral: Mindfulness and Attention Training14-day smartphone based mindfulness meditation attention monitoring and acceptance skills training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. |
| Monitor Only (MO-MBI) | Active comparator | Behavioral: Mindfulness training14-day smartphone based mindfulness meditation training intervention consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. |
| Coping Condition (CC) | Active comparator | Behavioral: Coping Condition14-day smartphone based training intervention focused on coping strategies consisting of a 5-minute introductory video, a 20-minute audio-guided lesson, plus daily life homework practice (3-10 minutes) each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rome IV IBS diagnosis
- Indicate moderate to high levels of psychological distress over the past two weeks (composite score >=4 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Attention TrainingAlso: MA-MBIGuided mindfulness meditation with attention monitoring and acceptance skills training | Behavioural | Monitor & Accept (MA-MBI) |
| Mindfulness trainingAlso: MO-MBIGuided mindfulness meditation, no attention monitoring or acceptance skills training | Behavioural | Monitor Only (MO-MBI) |
| Coping ConditionAlso: CCGuided training focused on coping effectiveness strategies, no monitoring or acceptance instruction | Behavioural | Coping Condition (CC) |
Primary outcome
Change in IBS Symptom Severity
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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).
IBS Symptom Improvement
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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 in Self-Reported Symptom-Related Psychological Outcomes
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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 in Self-Reported IBS Quality of Life
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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 in Microbiome Biology
Time frame: Change from baseline to 1-week post-intervention
Gut microbiome diversity evaluated using shotgun metagenomic sequencing for stool samples
Change in Self-Reported Perceptions of Stress
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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 in Self-Reported Perceptions of IBS Distress
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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 in Self-Reported Perceptions of IBS Distress During Bowel Movements
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
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).
Pain Tolerance following Cold Pressor Task
Time frame: Differences across all three conditions collected at post-intervention
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.
Sensation Intensity Rating following Cold Pressor Task
Time frame: Differences across all three conditions collected at post-intervention
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.
Distress Rating following Cold Pressor Task
Time frame: Differences across all three conditions collected at post-intervention
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.
8 secondary outcomes
Change in Self-Reported Perceived Stress
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Depressive Symptomatology
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Mindfulness
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Loneliness
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Distress Tolerance
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Perceived Partner Responsiveness
Time frame: Change from baseline to 1-week post-intervention and 2-month follow-up
Change in Self-Reported Sensitivity and Attention to Interoceptive Signals
Time frame: Change from baseline to 1-week post-intervention
Change in Gastrointestinal Symptom-Specific Anxiety
Time frame: Change from baseline to 1-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 15188733Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Adv Data. 2004 May 27;(343):1-19.
- Background: PubMed 18799450Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
- Background: PubMed 23527521Nyklicek I, Mommersteeg PM, Van Beugen S, Ramakers C, Van Boxtel GJ. Mindfulness-based stress reduction and physiological activity during acute stress: a randomized controlled trial. Health Psychol. 2013 Oct;32(10):1110-3. doi: 10.1037/a0032200. Epub 2013 Mar 25.
- Background: PubMed 24767614Creswell JD, Pacilio LE, Lindsay EK, Brown KW. Brief mindfulness meditation training alters psychological and neuroendocrine responses to social evaluative stress. Psychoneuroendocrinology. 2014 Jun;44:1-12. doi: 10.1016/j.psyneuen.2014.02.007. Epub 2014 Feb 23.
- Background: PubMed 19853530Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.
- Background: PubMed 21471390Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
- Background: PubMed 18835662Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4.
- Background: PubMed 21691341Gaylord SA, Palsson OS, Garland EL, Faurot KR, Coble RS, Mann JD, Frey W, Leniek K, Whitehead WE. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. Am J Gastroenterol. 2011 Sep;106(9):1678-88. doi: 10.1038/ajg.2011.184. Epub 2011 Jun 21.
- Background: PubMed 22161025Garland EL, Gaylord SA, Palsson O, Faurot K, Douglas Mann J, Whitehead WE. Therapeutic mechanisms of a mindfulness-based treatment for IBS: effects on visceral sensitivity, catastrophizing, and affective processing of pain sensations. J Behav Med. 2012 Dec;35(6):591-602. doi: 10.1007/s10865-011-9391-z. Epub 2011 Dec 8.
- Background: PubMed 20362976Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.
- Background: PubMed 22618308Zernicke KA, Campbell TS, Blustein PK, Fung TS, Johnson JA, Bacon SL, Carlson LE. Mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial. Int J Behav Med. 2013 Sep;20(3):385-96. doi: 10.1007/s12529-012-9241-6.
- Background: PubMed 25295066Aucoin M, Lalonde-Parsi MJ, Cooley K. Mindfulness-based therapies in the treatment of functional gastrointestinal disorders: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:140724. doi: 10.1155/2014/140724. Epub 2014 Sep 11.
- Individual participant dataSharing planned: Yes. The research team will share data associated with self-reports (e.g. demographics, stress levels) and adherence by depositing the data at the Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository. All data and documentation will be de-identified and will be consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards. This data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress report. The study team agrees to deposit and maintain the phenotypic data and secondary analysis of data (if any) at ICPSR. The repository has data access policies and procedures consistent with NIH data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. David Creswell, Ph.D. principal investigator
Carnegie Mellon University
Emily K Lindsay, Ph.D. study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Attention Training, Mindfulness training and Coping Condition in people with Irritable Bowel Syndrome, run by Carnegie Mellon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBS Symptom Severity (time frame: Change from baseline to 1-week post-intervention and 2-month follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083091, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.