Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders (PTSD)

August 29, 2023 updated by: Huiping Xu, Indiana University

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.

Study Overview

Status

Active, not recruiting

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 Type

Observational

Enrollment (Estimated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10-15 minutes
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).
10-15 minutes
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
12 weeks
Change in abdominal pain
Time Frame: 12 weeks
Abdominal pain will be measured using a validated daily bowel diary
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS or functional constipation (FC)
Time Frame: 20-30 minutes
Presence of IBS or FC will be determined based on responses to the validated IBS Rome IV Questionnaire
20-30 minutes
Psychological comorbidities
Time Frame: 20-30 minutes
Existence and severity of psychological comorbidities will be measured by the validated hospital anxiety and depression scale (HADS) questionnaire (range 0-14)
20-30 minutes
Health-related quality of life: Short Form-12 (SF-12)
Time Frame: 20-30 minutes
Health-related quality of life will be measured by responses to SF-12 (higher score is better, range 0-100)
20-30 minutes
Constipation-related symptoms
Time Frame: 12 weeks
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)
12 weeks
Constipation-related quality of life
Time Frame: 12 weeks
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)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Constipation

3
Subscribe