Irritable Bowel Syndrome Clinical Trial
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=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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Carnegie Mellon University | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Carnegie Mellon University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) |
United States,
Aucoin 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. — View Citation
Bangsgaard Bendtsen KM, Krych L, Sorensen DB, Pang W, Nielsen DS, Josefsen K, Hansen LH, Sorensen SJ, Hansen AK. Gut microbiota composition is correlated to grid floor induced stress and behavior in the BALB/c mouse. PLoS One. 2012;7(10):e46231. doi: 10.1371/journal.pone.0046231. Epub 2012 Oct 2. — View Citation
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. — View Citation
Blanchard EB, Lackner JM, Jaccard J, Rowell D, Carosella AM, Powell C, Sanders K, Krasner S, Kuhn E. The role of stress in symptom exacerbation among IBS patients. J Psychosom Res. 2008 Feb;64(2):119-28. doi: 10.1016/j.jpsychores.2007.10.010. — View Citation
Buono JL, Carson RT, Flores NM. Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea. Health Qual Life Outcomes. 2017 Feb 14;15(1):35. doi: 10.1186/s12955-017-0611-2. — View Citation
Carmody J, Baer RA, L B Lykins E, Olendzki N. An empirical study of the mechanisms of mindfulness in a mindfulness-based stress reduction program. J Clin Psychol. 2009 Jun;65(6):613-26. doi: 10.1002/jclp.20579. — View Citation
Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954. — View Citation
Chey WY, Jin HO, Lee MH, Sun SW, Lee KY. Colonic motility abnormality in patients with irritable bowel syndrome exhibiting abdominal pain and diarrhea. Am J Gastroenterol. 2001 May;96(5):1499-506. doi: 10.1111/j.1572-0241.2001.03804.x. — View Citation
Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23. — View Citation
Creswell 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. — View Citation
Creswell 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. — View Citation
Creswell 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. — View Citation
Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28. — View Citation
Delvaux M. Role of visceral sensitivity in the pathophysiology of irritable bowel syndrome. Gut. 2002 Jul;51 Suppl 1(Suppl 1):i67-71. doi: 10.1136/gut.51.suppl_1.i67. — View Citation
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available. — View Citation
Fichna J, Storr MA. Brain-Gut Interactions in IBS. Front Pharmacol. 2012 Jul 5;3:127. doi: 10.3389/fphar.2012.00127. eCollection 2012. — View Citation
Garland 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. — View Citation
Garland EL, Roberts-Lewis A, Tronnier CD, Graves R, Kelley K. Corrigendum to "Mindfulness-oriented recovery enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial" [Behav. Res. Ther. 77 (2016) 7-16]. Behav Res Ther. 2018 Jan;100:78. doi: 10.1016/j.brat.2017.09.007. Epub 2017 Sep 28. No abstract available. — View Citation
Gaylord 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. — View Citation
Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671. — View Citation
Jalanka J, Salonen A, Fuentes S, de Vos WM. Microbial signatures in post-infectious irritable bowel syndrome--toward patient stratification for improved diagnostics and treatment. Gut Microbes. 2015;6(6):364-9. doi: 10.1080/19490976.2015.1096486. Erratum In: Addendum to: Jalanka-Tuovinen J, Salojarvi J, Salonen A, Immonen O, Garsed K, Kelly FM, Zaitoun A, Palva A, Spiller RC, de Vos WM. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut 2014; 63:1737-45. — View Citation
Karl JP, Margolis LM, Madslien EH, Murphy NE, Castellani JW, Gundersen Y, Hoke AV, Levangie MW, Kumar R, Chakraborty N, Gautam A, Hammamieh R, Martini S, Montain SJ, Pasiakos SM. Changes in intestinal microbiota composition and metabolism coincide with increased intestinal permeability in young adults under prolonged physiological stress. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 1;312(6):G559-G571. doi: 10.1152/ajpgi.00066.2017. Epub 2017 Mar 23. — View Citation
Lee YJ, Park KS. Irritable bowel syndrome: emerging paradigm in pathophysiology. World J Gastroenterol. 2014 Mar 14;20(10):2456-69. doi: 10.3748/wjg.v20.i10.2456. — View Citation
Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134. — View Citation
Lindsay EK, Creswell JD. Mechanisms of mindfulness training: Monitor and Acceptance Theory (MAT). Clin Psychol Rev. 2017 Feb;51:48-59. doi: 10.1016/j.cpr.2016.10.011. Epub 2016 Nov 5. — View Citation
Lindsay EK, Creswell JD. Mindfulness, acceptance, and emotion regulation: perspectives from Monitor and Acceptance Theory (MAT). Curr Opin Psychol. 2019 Aug;28:120-125. doi: 10.1016/j.copsyc.2018.12.004. Epub 2018 Dec 13. — View Citation
Lindsay EK, Young S, Brown KW, Smyth JM, Creswell JD. Mindfulness training reduces loneliness and increases social contact in a randomized controlled trial. Proc Natl Acad Sci U S A. 2019 Feb 26;116(9):3488-3493. doi: 10.1073/pnas.1813588116. Epub 2019 Feb 11. — View Citation
Lindsay EK, Young S, Smyth JM, Brown KW, Creswell JD. Acceptance lowers stress reactivity: Dismantling mindfulness training in a randomized controlled trial. Psychoneuroendocrinology. 2018 Jan;87:63-73. doi: 10.1016/j.psyneuen.2017.09.015. Epub 2017 Oct 8. — View Citation
Ljotsson 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. — View Citation
Ljotsson B, Hedman E, Lindfors P, Hursti T, Lindefors N, Andersson G, Ruck C. Long-term follow-up of internet-delivered exposure and mindfulness based treatment for irritable bowel syndrome. Behav Res Ther. 2011 Jan;49(1):58-61. doi: 10.1016/j.brat.2010.10.006. Epub 2010 Oct 31. — View Citation
Lloyd-Price J, Arze C, Ananthakrishnan AN, Schirmer M, Avila-Pacheco J, Poon TW, Andrews E, Ajami NJ, Bonham KS, Brislawn CJ, Casero D, Courtney H, Gonzalez A, Graeber TG, Hall AB, Lake K, Landers CJ, Mallick H, Plichta DR, Prasad M, Rahnavard G, Sauk J, Shungin D, Vazquez-Baeza Y, White RA 3rd; IBDMDB Investigators; Braun J, Denson LA, Jansson JK, Knight R, Kugathasan S, McGovern DPB, Petrosino JF, Stappenbeck TS, Winter HS, Clish CB, Franzosa EA, Vlamakis H, Xavier RJ, Huttenhower C. Multi-omics of the gut microbial ecosystem in inflammatory bowel diseases. Nature. 2019 May;569(7758):655-662. doi: 10.1038/s41586-019-1237-9. Epub 2019 May 29. — View Citation
Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15. — View Citation
Ludwig 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. — View Citation
Mayer EA, Naliboff BD, Chang L, Coutinho SV. V. Stress and irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2001 Apr;280(4):G519-24. doi: 10.1152/ajpgi.2001.280.4.G519. — View Citation
Menees S, Chey W. The gut microbiome and irritable bowel syndrome. F1000Res. 2018 Jul 9;7:F1000 Faculty Rev-1029. doi: 10.12688/f1000research.14592.1. eCollection 2018. — View Citation
Midenfjord I, Polster A, Sjovall H, Tornblom H, Simren M. Anxiety and depression in irritable bowel syndrome: Exploring the interaction with other symptoms and pathophysiology using multivariate analyses. Neurogastroenterol Motil. 2019 Aug;31(8):e13619. doi: 10.1111/nmo.13619. Epub 2019 May 5. — View Citation
Nyklicek 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. Erratum In: Health Psychol. 2014 Sep;33(9):1045. — View Citation
O'Mahony SM, Marchesi JR, Scully P, Codling C, Ceolho AM, Quigley EM, Cryan JF, Dinan TG. Early life stress alters behavior, immunity, and microbiota in rats: implications for irritable bowel syndrome and psychiatric illnesses. Biol Psychiatry. 2009 Feb 1;65(3):263-7. doi: 10.1016/j.biopsych.2008.06.026. Epub 2008 Aug 23. — View Citation
Pace 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. — View Citation
Park SH, Videlock EJ, Shih W, Presson AP, Mayer EA, Chang L. Adverse childhood experiences are associated with irritable bowel syndrome and gastrointestinal symptom severity. Neurogastroenterol Motil. 2016 Aug;28(8):1252-60. doi: 10.1111/nmo.12826. Epub 2016 Apr 8. — View Citation
Rosenkranz MA, Davidson RJ, Maccoon DG, Sheridan JF, Kalin NH, Lutz A. A comparison of mindfulness-based stress reduction and an active control in modulation of neurogenic inflammation. Brain Behav Immun. 2013 Jan;27(1):174-84. doi: 10.1016/j.bbi.2012.10.013. Epub 2012 Oct 22. — View Citation
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415. — View Citation
Zeidan 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. — View Citation
Zeidan 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. — View Citation
Zernicke 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. — View Citation
* Note: There are 45 references in all — Click here to view all references
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 |
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