Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in State - based anxiety
研究概览
简要总结
The purpose of this research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with IBD who are undergoing surgery
详细描述
Pre- and post- surgery scores on the State Trait Anxiety Inventory will be used to measure levels of state-based anxiety as the primary outcome. Our hypothesis is that patients in the experimental group, will show a decrease in anxiety levels over the course of the four sessions, while the same group in the control group will not change significantly in their anxiety levels. It is hypothesized that this would be due to the psychotherapeutic intervention mitigating the inherent emotional stress and negative behavioral changes associated with surgery. It will be important to differentiate between the inpatient and outpatient groups, as their anxiety levels may inherently be discrepant. For patients with a three-step ileal pouch-anal anastomosis (IPAA), the three sessions subsequent to surgery will be conducted only after the first surgery. This is an exploratory study in which we are investigating the possibility of a range of potential outcomes to the intervention, including overall reduction of anxiety, depression, body image and improvement in quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age18 years or older.
- •Patients with documented diagnosis of Inflammatory Bowel Disease.
- •Patients with documented need for IBD surgery
排除标准
- •Patients younger than 18 years of age.
- •Patient who has any condition, including physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data and renders the patient an unsuitable candidate for the study.
结局指标
主要结局
Change in State - based anxiety
时间窗: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
State based anxiety will be measured by the State-Trait Anxiety Inventory. This measure has 40 items. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale.
次要结局
- Increase ability to function(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Improved self efficacy in participants(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in social support of participants(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in the participants' perception of illness(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in participant's level of depression(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in Quality of life of participants(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in the participants perception of body image(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Change in pain perception(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))
- Improvement in coping strategies(Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session))