This study aims to investigate how psychological therapies affect people with functional bowel disorders like irritable bowel syndrome (IBS.) Participants will be asked to complete 6 survey-based online questionnaires and then undergo a 12 week therapy program aimed at improving bowel symptoms and quality of life. Investigators will look at prevalence of post-traumatic stress disorder (PTSD) in patients with constipation symptoms.
The study consists of various visits starting with going to an initial screening at a local GI office for an exam and questionnaire. Participants will then record stool symptoms and patterns in a diary for 15 days. Following this, participants will have 60-minute regular sessions with a GI psychologist once a week for 10-12 weeks and learn relaxation techniques and given assignments to monitor progress. After this period, participants will be asked to fill out the same questionnaires from the beginning of the study. Investigators are looking for 370 participants. The study started on June 1, 2018 and is estimated to be completed by August 31, 2020.
The inclusion criteria differs based on the aims:
- Ages 18+
- Patients with a history of constipation based on clinical evaluation undergoing diagnostic testing for dyssynergic defecation with anorectal manometry with balloon expulsion test
- Patients with a history of constipation with or without dyssynergic 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).
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 postpartum 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
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Contact: Carolyn J Lockett 317-278-9296 firstname.lastname@example.org
Contact: Anita Gupta 3179489227 email@example.com
Indiana University Health
Indiana Clinical and Translational Sciences Institute
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