Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002529 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University Health | OTHER |
| Indiana Clinical and Translational Sciences Institute | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IBS or functional constipation (FC) | Presence of IBS or FC will be determined based on responses to the validated IBS Rome IV Questionnaire | 20-30 minutes |
| Psychological comorbidities | Existence and severity of psychological comorbidities will be measured by the validated hospital anxiety and depression scale (HADS) questionnaire (range 0-14) |
Not provided
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:
Exclusion Criteria:
For Aim 1, key exclusion criteria are:
In Aim 2, key exclusion criteria will include the aforementioned criteria listed in Aim 1 as well as the following:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of medicine | Indianapolis | Indiana | 46202 | United States |
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003248 | Constipation |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 20-30 minutes |
| Health-related quality of life: Short Form-12 (SF-12) | 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 | 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 | 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 |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |