Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders

Internet-delivered Psychological Treatment of Functional Gastrointestinal Disorders - A Danish Feasibility Study

Brief Summary

Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), are common conditions characterized by recurrent gastrointestinal symptoms that cannot be fully explained by structural disease. FGID are associated with reduced quality of life, functional impairment, psychiatric comorbidity, and high healthcare utilization. Psychological interventions, particularly cognitive behavioral therapy (CBT), have demonstrated beneficial effects in FGID, but access to specialized treatment remains limited.

This study aims to evaluate the feasibility, acceptability, and potential clinical effects of a Danish exposure-based internet-delivered cognitive behavioral therapy (iCBT) program for adults with FGID. The intervention has been translated and culturally adapted from a Swedish program with previously documented efficacy.

In this single-arm feasibility study, 30 adults with FGID will complete a 10-week therapist-supported iCBT program consisting of psychoeducation, symptom monitoring, identification of avoidance behaviors, exposure exercises, and relapse prevention strategies. Participants will receive asynchronous weekly written support from trained CBT therapists.

Feasibility outcomes include treatment adherence and completion, participant satisfaction, treatment credibility, working alliance, adverse effects, and acceptability of the internet platform. Clinical outcomes include gastrointestinal symptom severity and quality of life, alongside measures of illness perceptions, illness worry, emotional distress, behavioral responses, functional symptoms, and spontaneous cognition during rest. Assessments will be conducted at baseline, post-treatment, and 3-month follow-up.

The study is conducted in Denmark as part of The Danish FGID Treatment Study through collaboration between Aarhus University Hospital, Regional Hospital Silkeborg, Aarhus University, and Karolinska Institute, Sweden. The findings will inform the future implementation and evaluation of internet-delivered psychological treatment for Danish patients with FGID.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Gastrointestinal Disorders (FGID)
• Intervention / Treatment: Behavioral: I-CBT

Detailed Description

OBJECTIVE: To test the feasibility of an exposure-based internet-based cognitive behavioral therapy (ICBT) treatment not previously evaluated in Denmark for adults with FGID in a Danish clinical context.

DESIGN: This is a feasibility study testing a of an exposure-based I-CBT treatment for FGID not previously evaluated in Denmark.

PARTICIPANTS: 30 adults with functional gastrointestinal disorder

PROJECT GROUP: Lisbeth Frostholm (Principal Investigator); Charlotte Ulrikka Rask (Principal Investigator); Karen Hansen Kallesøe; Heidi Frølund Pedersen; Lotte Fynne; Lise Gormsen (FL); Laura Krogsgaard (FL). Brjann Ljötsson, Erik Hedman

The Danish FGID Treatment Study is a joint cooperation between Regional Hospital Silkeborg, Department of Functional Disorders (FL), Aarhus University Hospital, the Research Unit at the Department of Child and Adolescent Psychiatry (BUA), Aarhus University Hospital, the Department of Clinical Medicine (CM), Aarhus University, and the Department of Clinical Neuroscience (CNS) at the Karolinska Institute in Stockholm, Sweden.

The trial will be conducted by the research group at the Dept. of Functional Disorders (www.functionaldisorders.dk), based at Aarhus University Hospital, Denmark. The clinic was established in 1999 and offers assessment and specialized treatment to patients with severe FSD. Patients are recruited from Regional Hospital Silkeborg

MAIN HYPOTHESIS: The feasibility of the I-CBT program will be assessed positively by the patients. At least 70% of included patients will complete the treatment. Furthermore, the I-CBT program will reduce symptoms of FGID and increase quality of life in patients with FGID.

INTERVENTION: The i-CBT program build on exposure based therapy and consists of 5 modules and takes 10 weeks to complete. The participants will be expected to use approximately 4 hours per week on the treatment. Asynchronous written support will be provided by a therapist on a weekly basis.

MEASUREMENTS: Self-reported measures will be administered to patients at several timepoints during the course of treatment, including before the start of the program (baseline, 0 weeks), after treatment (10 weeks), at the 3-month follow-up (22 weeks, primary endpoint), Beyond this, patients will receive a short daily questionnaire 5 times a day for 2 week (week 2 and week 8 into treatment)

Furthermore, therapist will evaluate patients' progress post-treatment (after 10 weeks). Therapists will record number and time usage of telephone/video consultations throughout the treatment. The treatment program will continually log the participants' data during the treatment period.

For a detailed list of the measures and measurement time points included, see the section "Outcome measures".

ANALYSIS: Data will be presented and analyzed according to current guidelines for feasibility studies

ETHICAL CONSIDERATIONS: The fesibility study presents low risks (side-effects and/or disadvantages) for the patients who may end their participation at any time point and can get into contact with a physician if their physical/mental health state deteriorates significantly. After patients have reached their final end-point, at the 3-month follow-up, they will be invited to a follow-up consultation with a medical doctor where their health/mental status will be assessed, and the need for further treatment discussed.

A study protocol has been approved by the Research Ethics Board of Aarhus University Hospital for approval (case.nr. 1-10-72-127-25). A pre-registration of the study has been submitted to ClinicalTrials.gov before the onset of the feasibility study. Data will be handled according to Danish law on the Data Protection Act and the Data Protection Regulation, and have been approved by the Danish Data Protection Agency (case.nr. 772917).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi F Pedersen, Ph.D.; Phone Number: 0045-78464310; Email: heidpd@rm.dk
• Study Contact Backup: Name: Lise Gormsen, Ph.D.; Phone Number: 0045-78464310; Email: lisegorm@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18.
2. A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58)
3. Normal recommended routine medical investigations: growth, blood samples including TSH, total IgA, IgA-tissue transglutaminase, complete blood count, erythrocyte sedimentation rate and C-reactive protein analysis, liver enzymes and fecal calprotectin.
4. Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines)
5. Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month.
6. Living in Denmark.

7. Access to a computer or tablet with an internet connection.

   -

Exclusion Criteria:

1. - Another disease that explains the symptoms.
2. Chronic inflammatory bowel disease (e.g., Crohns, colitis ulcerosa).
3. Lactose intolerance, celiac disease, and food allergies, in accordance with guidelines.
4. Severe psychiatric problems (e.g., suicidal ideation, depression).
5. Insufficient language or computer skills.
6. Addiction to alcohol, drugs or medicine.
7. Treatment with opioids or other addictive drugs such as benzodiazepines
8. Lactose-/gluten-intolerance where the diet has not been adjusted accordingly.
9. Severe cognitive or intellectual dysfunction or diagnosed autism spectrum disorder, which prevent the participant from interaction with the program
10. Ongoing psychological treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Internet-delivered psychological treatment for FGID; The i-CBT program consists of 5 modules and takes 10 weeks to complete.

Behavioral: I-CBT; Experimental : Internet-delivered psychological treatment for FGID The i-CBT program consists of 5 modules and takes 10 weeks to complete. The participants will be expected to use approximately 4 hours per week on the treatment. Asynchronous written support will be provided by a therapist on a weekly basis. The therapists are experienced in CBT treatment and will receive regular supervision by the Swedish collaborators. The treatment program consists of the following. 1) Thorough information regarding FGID provided as text. 2) Introduction to basic treatment principles of CBT provided as text. 3) Exercises to help the patients become aware of their FGID symptoms and FGID-related thoughts in daily life. 4) Exercises to help the patients discover what they have been avoiding due to their symptoms (e.g. specific foods, situations or activities). 5) Exposure exercises to previously avoided foods, situations or activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRSIBS; Wiklund et al. 2003)	20 item measure of gastrointestinal symptoms measured at a 0-6 scale	Distributed at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Irritable Bowel Syndrome Quality of Life (IBS-QOL; Patrick et al., 1998)	34 items on quality of life measured a a 0-4 scale	Measured at baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROME IV	Measures gastrointestinal symptoms, 5 items at a 0-8 scale	Baseline and 3 month follow-up
NIAS: Nine Item Avoidant/Restrictive Food Intake disorder screen	Measures food intake, 9 items at a 0-5 scale	At screening (before inclusion) and 3 month follow-up
Bodily Distress Syndrome Checklist (BDS Checklist; Budtz-Lilly et al., 2015)	25 items on bodily symptoms from 4 organ systems, measured on a 0-4 scale	Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 months follow-up
Illness Perception Questionnaire (IPQ; Broadbent et al., 2006, 2015)	21 items on illness perception measured of which 9 are measured at a 0-10 scale 1 item at a categorical scale consisting of 4 categories 1 open-ended questions on the cause of symptoms (possible to write up to 3 different causes) 10 items measured at a 0-3 scale	Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Whiteley index (Conradt et al., 2006; Fink et al., 1999)	8 items measured at a 0-4 scale	Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Symptom Check List - Anxiety and Depression subscales (SCL-ANX &´SCL-DEP; Christensen et al., 2005; Derogatis, 1983)	Symptoms of anxiety and depression, 13 items measured at a 0-4 scale	Screening, baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Questionnaire on healthcare consumption and productivity losses for patients with a psychiatric disorder (TiC-P; Bouwmans et al., 2013)	Working hours and sick leave, 10 items of which 6 items are mesured as days 3 items as dichotomized (yes/no) 1 item measured at a 0-10 scale	Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Amsterdam Resting State Questionnaire (ARSQ; Diaz et al., 2013, 2014)	44 items of which 36 items are measured at a 0-4 scale 6 measured as dichotomized (yes/no) 1 item on a 1-4 scale 1 open space to write a comment	Baseline, end of treatment (i.e. after 10 weeks of treatment), and 3 month follow-up
Patient global impression of change (PGIC; Guy, 1976; Perrot & Lantéri- Minet, 2019)	Self-perceived change, 1 items measured at 5 point scale (0-4)	end of treatment (i.e. after 10 weeks of treatment),
Mind-wandering in daily life (Kane et al. 2007)	Mind-wandering measured 5 times a day over 2 seperate weeks with 5 items measured at a 0-4 scale	5 times a day over 2 seperate weeks (week 2 and 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectation for counseling success (ECS; Kim et al., 2005)	6 items on a 0-10 scale	Baseline and end of treatment (i.e. after 10 weeks of treatment),
Evaluation of the treatment	5 items measured at 0-3 and 3 open-ended questions	end of treatment (i.e. after 10 weeks of treatment),
Evaluation of assessment at the doctor	3 items measured at 0-3 and 3 open-ended questions	Baseline
Working Alliance Inventory - Short Form (WAI-SF; Tracey & Kokotovic, 1989)	12 items measured at a 0-6 scale	end of treatment (i.e. after 10 weeks of treatment),
Inventory for the balanced assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief & Nestoriuc, 2014)	41 items on potential side effects: 16 items measured at 0-3 13 items rating whether a side effect was caused by the treatment (worse, not relevant, better) 2 open ended questions	end of treatment (i.e. after 10 weeks of treatment),
LEVA	Evaluation of the internet program, 6 items at a 0-5 scale	end of treatment (i.e. after 10 weeks of treatment),

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Lisbeth Frostholm, Professor, Department for Functional Disorders, Aarhus University Hospital/Aarhus University

Publications and helpful links

General Publications

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
• 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.
• 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.
• Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
• Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942.
• Budtz-Lilly A, Fink P, Ornbol E, Vestergaard M, Moth G, Christensen KS, Rosendal M. A new questionnaire to identify bodily distress in primary care: The 'BDS checklist'. J Psychosom Res. 2015 Jun;78(6):536-45. doi: 10.1016/j.jpsychores.2015.03.006. Epub 2015 Mar 16.
• Fink P, Ewald H, Jensen J, Sorensen L, Engberg M, Holm M, Munk-Jorgensen P. Screening for somatization and hypochondriasis in primary care and neurological in-patients: a seven-item scale for hypochondriasis and somatization. J Psychosom Res. 1999 Mar;46(3):261-73. doi: 10.1016/s0022-3999(98)00092-0.
• Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, Hakkaart-van Roijen L. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013 Jun 15;13:217. doi: 10.1186/1472-6963-13-217.
• Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209.
• Christensen KS, Fink P, Toft T, Frostholm L, Ornbol E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005 Aug;22(4):448-57. doi: 10.1093/fampra/cmi025. Epub 2005 Apr 6.
• Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30(11):1361-85. doi: 10.1080/08870446.2015.1070851. Epub 2015 Aug 26.
• Schmulson MJ, Drossman DA. What Is New in Rome IV. J Neurogastroenterol Motil. 2017 Apr 30;23(2):151-163. doi: 10.5056/jnm16214.
• Petersen MW, Schroder A, Jorgensen T, Ornbol E, Meinertz Dantoft T, Eliasen M, Benros ME, Fink P. Irritable bowel, chronic widespread pain, chronic fatigue and related syndromes are prevalent and highly overlapping in the general population: DanFunD. Sci Rep. 2020 Feb 24;10(1):3273. doi: 10.1038/s41598-020-60318-6.
• Van Oudenhove L, Crowell MD, Drossman DA, Halpert AD, Keefer L, Lackner JM, Murphy TB, Naliboff BD, Levy RL. Biopsychosocial Aspects of Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00218-3. doi: 10.1053/j.gastro.2016.02.027. Online ahead of print.
• Ford AC, Sperber AD, Corsetti M, Camilleri M. Irritable bowel syndrome. Lancet. 2020 Nov 21;396(10263):1675-1688. doi: 10.1016/S0140-6736(20)31548-8. Epub 2020 Oct 10.
• World Health Organization (WHO) (1998). SCAN. Schedules for Clinical Assessment in Neuropsychiatry. Geneva: WHO.
• Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology, 1, 207-210. https://doi.org/10.1037/1040-3590.1.3.207
• Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 May 20;2:25. doi: 10.1186/s40814-016-0065-z. eCollection 2016.
• Sankarpandi SK, Baldwin AJ, Ray J, Mazza C. Reliability of inertial sensors in the assessment of patients with vestibular disorders: a feasibility study. BMC Ear Nose Throat Disord. 2017 Feb 2;17:1. doi: 10.1186/s12901-017-0034-z. eCollection 2017.
• Ljotsson B, Hesser H, Andersson E, Lackner JM, El Alaoui S, Falk L, Aspvall K, Fransson J, Hammarlund K, Lofstrom A, Nowinski S, Lindfors P, Hedman E. Provoking symptoms to relieve symptoms: a randomized controlled dismantling study of exposure therapy in irritable bowel syndrome. Behav Res Ther. 2014 Apr;55:27-39. doi: 10.1016/j.brat.2014.01.007. Epub 2014 Feb 10.
• Ljotsson B, Hedman E, Andersson E, Hesser H, Lindfors P, Hursti T, Rydh S, Ruck C, Lindefors N, Andersson G. Internet-delivered exposure-based treatment vs. stress management for irritable bowel syndrome: a randomized trial. Am J Gastroenterol. 2011 Aug;106(8):1481-91. doi: 10.1038/ajg.2011.139. Epub 2011 May 3.
• Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot Feasibility Stud. 2019 Oct 6;5:114. doi: 10.1186/s40814-019-0499-1. eCollection 2019.
• Lalouni M, Ljotsson B, Bonnert M, Hedman-Lagerlof E, Hogstrom J, Serlachius E, Olen O. Internet-Delivered Cognitive Behavioral Therapy for Children With Pain-Related Functional Gastrointestinal Disorders: Feasibility Study. JMIR Ment Health. 2017 Aug 10;4(3):e32. doi: 10.2196/mental.7985.
• Ladwig, I., Rief, W., & Nestoriuc, Y. (2014). What Are the Risks and Side Effects of Psychotherapy? - Development of an Inventory for the Assessment of Negative Effects of Psychotherapy (INEP). Verhaltenstherapie,
• Kinsinger SW. Cognitive-behavioral therapy for patients with irritable bowel syndrome: current insights. Psychol Res Behav Manag. 2017 Jul 19;10:231-237. doi: 10.2147/PRBM.S120817. eCollection 2017.
• Kim, B. S. K., Ng, G. F., Ahn, A. J. (2005). Effects of Client Expectation for Counseling Success, Client-Counselor Worldview Match, and Client Adherence to Asian and European American Cultural Values on Counseling Process With Asian Americans. Journal of Counseling Psychology, 52(1), 67-76. https://doi.org/10.1037/0022-0167.52.1.67
• Mashkovskii MD, Andreeva NI. [An experimental study of the psychotropic action of pyrazidol]. Farmakol Toksikol. 1975 Jan-Feb;38(1):5-10. No abstract available. Russian.
• Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Rockville, MD: US Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch. Division of Extramural Research Programs.
• Fink P, Orbol E, Hansen MS, Sondergaard L, De Jonge P. Detecting mental disorders in general hospitals by the SCL-8 scale. J Psychosom Res. 2004 Mar;56(3):371-5. doi: 10.1016/S0022-3999(03)00071-0.
• Diaz BA, Van Der Sluis S, Moens S, Benjamins JS, Migliorati F, Stoffers D, Den Braber A, Poil SS, Hardstone R, Van't Ent D, Boomsma DI, De Geus E, Mansvelder HD, Van Someren EJ, Linkenkaer-Hansen K. The Amsterdam Resting-State Questionnaire reveals multiple phenotypes of resting-state cognition. Front Hum Neurosci. 2013 Aug 8;7:446. doi: 10.3389/fnhum.2013.00446. eCollection 2013.
• Diaz BA, Van Der Sluis S, Benjamins JS, Stoffers D, Hardstone R, Mansvelder HD, Van Someren EJ, Linkenkaer-Hansen K. The ARSQ 2.0 reveals age and personality effects on mind-wandering experiences. Front Psychol. 2014 Apr 3;5:271. doi: 10.3389/fpsyg.2014.00271. eCollection 2014.
• Derogatis L. R. (1983). SCL-90-R. Administration, scoring, and procedures. MANUAL-II. Towson, MD: Clinical Psychometric Research.
• Conradt M, Cavanagh M, Franklin J, Rief W. Dimensionality of the Whiteley Index: assessment of hypochondriasis in an Australian sample of primary care patients. J Psychosom Res. 2006 Feb;60(2):137-43. doi: 10.1016/j.jpsychores.2005.07.003.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases
• Other Study ID Numbers: FGID pilot study; ID: 147092 (Other Grant/Funding Number: Trygfonden)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study, and we have not yet decided on procedures of sharing data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No