Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients

NCT ID: NCT04582071

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-08-31

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.

Conditions

Anxiety Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 (Psychotherapy, Intervention arm)

Subjects undergoing a 3 step IPAA will receive the four sessions of psychotherapy preceding and following their first surgery only, and receive an additional set of questionnaires again after their third surgery.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

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.

Arm 2 (Non-Therapy, Control Arm)

Subjects will receive questionnaires which will be administered remotely via telemedicine if patient and psychologist/ research team member are unable to meet in person.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Gerson, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

20-00275

Identifier Type: -

Identifier Source: org_study_id