Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060121
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Indiana University Health
Indiana Clinical and Translational Sciences Institute
Information provided by (Responsible Party):
Andrea Shin, Indiana University

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 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.


Condition or disease
IBS - Irritable Bowel Syndrome Constipation

Detailed Description:

For Aim 1, investigators will conduct a cross-sectional survey study examining prevalence of early adverse life events and post-trauamatic stress disorder (PTSD) in patients with constipation-predominant IBS or chronic constipation.

For Aim 2, investigators will recruit and enroll individuals who have a history of early adverse life events or possible PTSD 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.
  • Vital signs will be measured.
  • 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
  • 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.

Visit 14:

  • After participants have completed your treatment sessions, they will be asked to fill out the same questionnaires that they completed at the screening visit.
  • We will also confirm completion of the study.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders With History of Early Adverse Life Events or Post-traumatic Stress Disorder
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021



Primary Outcome Measures :
  1. 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)

  2. 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).

  3. 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

  4. Change in abdominal pain [ Time Frame: 12 weeks ]
    Abdominal pain will be measured using a validated daily bowel diary


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060121


Contacts
Layout table for location contacts
Contact: Carolyn J Lockett 3172789296 clocket@iu.edu
Contact: Anita Gupta 3179489227 anigupta@iu.edu

Locations
Layout table for location information
United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carolyn J Lockett    317-278-9296    carolynlockett397@gmail.com   
Contact: Anita Gupta    3179489227    anigupta@iu.edu   
Principal Investigator: Andrea s shin         
Sponsors and Collaborators
Indiana University
Indiana University Health
Indiana Clinical and Translational Sciences Institute

Layout table for additonal information
Responsible Party: Andrea Shin, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04060121     History of Changes
Other Study ID Numbers: 1802270023
UL1TR002529 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Shin, Indiana University:
early adverse life events
ptsd
cognitive behavioral therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Intestinal Diseases
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Gastrointestinal Diseases
Digestive System Diseases