Trials / Withdrawn
WithdrawnNCT04582071
Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Psychotherapy | Psychotherapy is a term that we use to describe the use of the psychological method to understand and improve an individual's well-being and mental health. The Principal Investigator of this study, a clinical psychologist will be leading each of the sessions. |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2021-08-01
- Completion
- 2022-08-01
- First posted
- 2020-10-09
- Last updated
- 2021-09-01
Source: ClinicalTrials.gov record NCT04582071. Inclusion in this directory is not an endorsement.