Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    370
  • sponsor
    Indiana University
Updated on 27 January 2021
constipation
bowel dysfunction
balloon expulsion test
anorectal manometry

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.

In Aim 2 of this study will monitor the effectiveness of a 12 week therapy program on bowel symptoms and overall quality of life.

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.

Details
Condition Constipation, Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome (IBS- Pediatric)
Clinical Study IdentifierNCT04060121
SponsorIndiana University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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