Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders With History of Early Adverse Life Events or Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Post-traumatic Stress Disorder (PTSD)
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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).
排除标准
- •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
结局指标
主要结局
Post-traumatic Stress Disorder (PTSD)
时间窗: 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).
Change in weekly number of complete spontaneous bowel movements
时间窗: 12 weeks
The weekly number of complete spontaneous bowel movements will be measured using a validated daily bowel diary
Change in abdominal pain
时间窗: 12 weeks
Abdominal pain will be measured using a validated daily bowel diary
Early adverse life events (EALS)
时间窗: 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)
次要结局
- Psychological comorbidities(20-30 minutes)
- Constipation-related symptoms(12 weeks)
- Constipation-related quality of life(12 weeks)
- IBS or functional constipation (FC)(20-30 minutes)
- Health-related quality of life: Short Form-12 (SF-12)(20-30 minutes)
研究者
Huiping Xu
Associate Professor
Indiana University