IBS - Irritable Bowel SyndromePTSDNCT04060121
Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders
An observational study of IBS - Irritable Bowel Syndrome and Constipation, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is study bowel symptoms, quality of life, and personal factors that may affect your health. In Aim 1 of this study participants will be invited to complete 6 survey-based questionnaires online. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Constipation
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 29 Nov 2022
- Phase
- Observational
- 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
Study population: All adults' ages 18 years or older will be eligible for participation. We will solicit participation and extend survey invitations to participants who have undergone clinical evaluation for constipation with anorectal manometry and balloon expulsion testing at the IU GI Motility Laboratory.
Who may be able to join
- Aim 1:
- -Patients with a history of constipation based on clinical evaluation undergoing diagnostic testing for dyssynergic defecation with anorectal manometry with balloon expulsion test, ages 18 years or older.
- Aim 2:
- Patients with a history of constipation with or without dyssernergic defecation and a positive history of EALs or PTSD, as identified in Aim 1 based on survey responses.
- Any positive history regardless of symptom severity will be considered. Positive history will be defined by an ACE score of 1 or higher OR a provisional diagnosis of PTSD. A provisional PTSD diagnosis can be made by treating each PCL-5 item rated as 2 = "Moderately" or higher as a symptom endorsed. The diagnostic rule will require a rating of "moderate" for the following: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), and 2 E items (questions 15-20).
Who cannot join
- For Aim 1, key exclusion criteria are:
- Patients who are currently hospitalized
- Patients who are unable to consent
- Patients with microscopic colitis, inflammatory bowel disease, or celiac disease, visceral cancer, or uncontrolled thyroid disease.
- In Aim 2, key exclusion criteria will include the aforementioned criteria listed in Aim 1 as well as the following:
- Patients who have bipolar disorder including active or recent hypomanic/manic episode
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- Patients at imminent risk for harm to self or others
- Patients unable to follow orders
- Patients who have a history of organic brain disease
- Patient using illicit substances
- Pregnant or post-partum patients
- Patients who are homeless or lacking sufficient social support for follow-up care
- Patients with acute stress disorder as determined by the GI psychologist
- Patients with or severe PTSD as determined by the GI psychologist
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of medicine
Indianapolis, Indiana, 46202
About this study
Official title: Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders With History of Early Adverse Life Events or Post-traumatic Stress Disorder
The purpose of this study is study bowel symptoms, quality of life, and personal factors that may affect your health. In Aim 1 of this study participants will be invited to complete 6 survey-based questionnaires online.
In Aim 2 of this study will monitor the effectiveness of a 12 week therapy program on bowel symptoms and overall quality of life.
Read the detailed description
For Aim 1, investigators will conduct a cross-sectional survey study examining prevalence of early adverse life events and post-traumatic stress disorder (PTSD) in patients with constipation-predominant IBS or chronic constipation with or without overlapping dyssynergic defecation.
For Aim 2, investigators will recruit and enroll individuals who have a positive history of early adverse life events or possible PTSD as identified in Aim 1 for a 12 week outpatient cognitive behavioral therapy program as outlined below:
Visit 1 (Participants will present to the GI Office at one of our dedicated locations including the downtown Digestive and Liver Disorders (DaLD) clinic, Springmill Clinic, or IU North Multispeciality Clinic) At this screening visit, participants do the following:
- Read and sign the informed consent after all your questions about the study will be answered
- Have a medical history taken including demographics, symptoms and history of illness
- Medications will be reviewed
- A physical exam will be performed by the physician if the visit is being conducted in person. If the visit is done virtually, the physician will record that exam as a virtual exam with all relevant information that can be gathered by a virtual exam.
- Vital signs will be measured if the visit is conducted in person. If the visit is virtual, vital signs will not be physically done but any available data pertaining to vital signs will be documented.
- Participants will be asked to complete a series of questionnaires
- Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study
- Participants will be asked to complete global assessment scales (2 questions) during each week of the study
- Participants will be administered the PAC-SYM, PAC-QOL, global assessment scale, SF-12, HADS and PCL-5 during CBT
- Participants will be administered the GAD-7 and PHQ-9 at every CBT visit.
- The study visit may take 30 minutes to 1 hour to complete
Day 1-15 (Run-In Phase):
- Participants be asked to record stool symptoms and patterns in a diary daily starting from Day 1 to Day 15. The daily dairy can either be completed on paper or by phone or on the web.
Day 16-100 (Visit 2-13): During this time, participants will undergo regular sessions with a dedicated GI psychologist. They will receive one 60-minute session every week for 10-12 weeks. The treatment schedule will include education on the relationship between bowel symptoms and stressful life events with instructions on ways to cope and manage symptoms through the use of relaxation techniques, such as breathing exercises and other methods for self calming. During the 10 to 12 weeks of therapy, participants will be given assignments and asked to monitor your progress. After you have completed your treatment sessions, you will be asked to fill out the same questionnaires that you completed at your screening visit that can be done either in person using a physical form or virtually online.
Visit 14:
- We will also confirm completion of the study.
- Conditions
- IBS - Irritable Bowel Syndrome, Constipation
- Keywords
- early adverse life events, ptsd, cognitive behavioral therapy
- Medical subject headings
- Irritable Bowel Syndrome, Constipation, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Early adverse life events (EALS)
Presence of early adverse life events will be determine by self-reported questionnaire responses to the adverse childhood experiences (ACE) questionnaire (ACE score of one or higher, range 0-8)
Measured: 10-15 minutes
Post-traumatic Stress Disorder (PTSD)
Prevalence of PTSD will be determined by self-reported questionnaire responses to PTSD Checklist (PCL-5) questionnaire (range 0-80). A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).
Measured: 10-15 minutes
Change in weekly number of complete spontaneous bowel movements
The weekly number of complete spontaneous bowel movements will be measured using a validated daily bowel diary
Measured: 12 weeks
Change in abdominal pain
Abdominal pain will be measured using a validated daily bowel diary
Measured: 12 weeks
Secondary outcomes (5)
IBS or functional constipation (FC)
Presence of IBS or FC will be determined based on responses to the validated IBS Rome IV Questionnaire
Measured: 20-30 minutes
Psychological comorbidities
Existence and severity of psychological comorbidities will be measured by the validated hospital anxiety and depression scale (HADS) questionnaire (range 0-14)
Measured: 20-30 minutes
Health-related quality of life: Short Form-12 (SF-12)
Health-related quality of life will be measured by responses to SF-12 (higher score is better, range 0-100)
Measured: 20-30 minutes
Constipation-related symptoms
Change in constipation-related symptoms will be measured using the validated in Patient Assessment of Constipation Symptoms questionnaire (higher score is worse, score range 0-4)
Measured: 12 weeks
Constipation-related quality of life
Change in constipation-related quality of life will be measured using the validated patient assessement of constipation quality of life questionnaire (higher score is worse, score range 0-4)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Jun 2018
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, Indiana Clinical and Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Huiping Xu, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060121
- Sponsor's protocol ID
- 1802270023
- Other IDs
- UL1TR002529
- Acronym
- PTSD
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2019
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders With History of Early Adverse Life Events or Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04060121
- Acronym / sponsor ID
- PTSD / 1802270023
- Conditions
- IBS - Irritable Bowel Syndrome, Constipation
- Keywords
- early adverse life events, ptsd, cognitive behavioral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health, Indiana Clinical and Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 16 Aug 2019 (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.
The purpose of this study is study bowel symptoms, quality of life, and personal factors that may affect your health. In Aim 1 of this study participants will be invited to complete 6 survey-based questionnaires online.
In Aim 2 of this study will monitor the effectiveness of a 12 week therapy program on bowel symptoms and overall quality of life.
Detailed description
For Aim 1, investigators will conduct a cross-sectional survey study examining prevalence of early adverse life events and post-traumatic stress disorder (PTSD) in patients with constipation-predominant IBS or chronic constipation with or without overlapping dyssynergic defecation.
For Aim 2, investigators will recruit and enroll individuals who have a positive history of early adverse life events or possible PTSD as identified in Aim 1 for a 12 week outpatient cognitive behavioral therapy program as outlined below:
Visit 1 (Participants will present to the GI Office at one of our dedicated locations including the downtown Digestive and Liver Disorders (DaLD) clinic, Springmill Clinic, or IU North Multispeciality Clinic) At this screening visit, participants do the following:
- Read and sign the informed consent after all your questions about the study will be answered
- Have a medical history taken including demographics, symptoms and history of illness
- Medications will be reviewed
- A physical exam will be performed by the physician if the visit is being conducted in person. If the visit is done virtually, the physician will record that exam as a virtual exam with all relevant information that can be gathered by a virtual exam.
- Vital signs will be measured if the visit is conducted in person. If the visit is virtual, vital signs will not be physically done but any available data pertaining to vital signs will be documented.
- Participants will be asked to complete a series of questionnaires
- Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study
- Participants will be asked to complete global assessment scales (2 questions) during each week of the study
- Participants will be administered the PAC-SYM, PAC-QOL, global assessment scale, SF-12, HADS and PCL-5 during CBT
- Participants will be administered the GAD-7 and PHQ-9 at every CBT visit.
- The study visit may take 30 minutes to 1 hour to complete
Day 1-15 (Run-In Phase):
- Participants be asked to record stool symptoms and patterns in a diary daily starting from Day 1 to Day 15. The daily dairy can either be completed on paper or by phone or on the web.
Day 16-100 (Visit 2-13): During this time, participants will undergo regular sessions with a dedicated GI psychologist. They will receive one 60-minute session every week for 10-12 weeks. The treatment schedule will include education on the relationship between bowel symptoms and stressful life events with instructions on ways to cope and manage symptoms through the use of relaxation techniques, such as breathing exercises and other methods for self calming. During the 10 to 12 weeks of therapy, participants will be given assignments and asked to monitor your progress. After you have completed your treatment sessions, you will be asked to fill out the same questionnaires that you completed at your screening visit that can be done either in person using a physical form or virtually online.
Visit 14:
- We will also confirm completion of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults' ages 18 years or older will be eligible for participation. We will solicit participation and extend survey invitations to participants who have undergone clinical evaluation for constipation with anorectal manometry and balloon expulsion testing at the IU GI Motility Laboratory.
Key inclusion criteria (5 listed)
- -Patients with a history of constipation based on clinical evaluation undergoing diagnostic testing for dyssynergic defecation with anorectal manometry with balloon expulsion test, ages 18 years or older.
- Patients with a history of constipation with or without dyssernergic defecation and a positive history of EALs or PTSD, as identified in Aim 1 based on survey responses.
- Any positive history regardless of symptom severity will be considered. Positive history will be defined by an ACE score of 1 or higher OR a provisional diagnosis of PTSD. A provisional PTSD diagnosis can be made by treating each PCL-5 item rated as 2 = "Moderately" or higher as a symptom endorsed. The diagnostic rule will require a rating of "moderate" for the following: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), and 2 E items (questions 15-20).
Key exclusion criteria (14 listed)
- Patients who are currently hospitalized
- Patients who are unable to consent
- Patients with microscopic colitis, inflammatory bowel disease, or celiac disease, visceral cancer, or uncontrolled thyroid disease.
- In Aim 2, key exclusion criteria will include the aforementioned criteria listed in Aim 1 as well as the following:
- Patients who have bipolar disorder including active or recent hypomanic/manic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early adverse life events (EALS)
Time frame: 10-15 minutes
Presence of early adverse life events will be determine by self-reported questionnaire responses to the adverse childhood experiences (ACE) questionnaire (ACE score of one or higher, range 0-8)
Post-traumatic Stress Disorder (PTSD)
Time frame: 10-15 minutes
Prevalence of PTSD will be determined by self-reported questionnaire responses to PTSD Checklist (PCL-5) questionnaire (range 0-80). A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).
Change in weekly number of complete spontaneous bowel movements
Time frame: 12 weeks
The weekly number of complete spontaneous bowel movements will be measured using a validated daily bowel diary
Change in abdominal pain
Time frame: 12 weeks
Abdominal pain will be measured using a validated daily bowel diary
5 secondary outcomes
IBS or functional constipation (FC)
Time frame: 20-30 minutes
Psychological comorbidities
Time frame: 20-30 minutes
Health-related quality of life: Short Form-12 (SF-12)
Time frame: 20-30 minutes
Constipation-related symptoms
Time frame: 12 weeks
Constipation-related quality of life
Time frame: 12 weeks
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 29 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS - Irritable Bowel Syndrome and Constipation, run by Indiana 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 5 inclusion and 14 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 29 Apr 2024. 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?
Early adverse life events (EALS) (time frame: 10-15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.