Status:
COMPLETED
Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana University Health
Indiana Clinical and Translational Sciences Institute
Conditions:
IBS - Irritable Bowel Syndrome
Constipation
Eligibility:
All Genders
18+ years
Brief 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 que...
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-predomina...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04060121
Start Date
June 1 2018
End Date
November 29 2022
Last Update
April 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University School of medicine
Indianapolis, Indiana, United States, 46202