Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders

NCT04060121 | Completed

• 2 other identifiers: 1802270023UL1TR002529
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome; Constipation

Keywords

early adverse life events; ptsd; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (4)

• Early adverse life events (EALS)

  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)

  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

  The weekly number of complete spontaneous bowel movements will be measured using a validated daily bowel diary

  12 weeks

• Change in abdominal pain

  Abdominal pain will be measured using a validated daily bowel diary

  12 weeks

Secondary Outcomes (5)

• IBS or functional constipation (FC)

  20-30 minutes

• Psychological comorbidities

  20-30 minutes

• Health-related quality of life: Short Form-12 (SF-12)

  20-30 minutes

• Constipation-related symptoms

  12 weeks

• Constipation-related quality of life

  12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator
• Indiana Clinical and Translational Sciences Institute: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Indiana University School of medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 16, 2019
• Study Start: June 1, 2018
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (1)