Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Depression
- Sponsor
- NYU Langone Health
- Primary Endpoint
- Change in State - based anxiety
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients age18 years or older.
- •Patients with documented diagnosis of Inflammatory Bowel Disease.
- •Patients with documented need for IBD surgery
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in State - based anxiety
Time Frame: 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.
Secondary Outcomes
- 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))