Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients

NCT04582071 | Withdrawn DMC

• 1 other identifier: 20-00275
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• Change in State - based anxiety

  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.

  Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)

Secondary Outcomes (9)

• 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)

• 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)

Study Arms (2)

Arm 1 (Psychotherapy, Intervention arm)

EXPERIMENTAL

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.

Behavioral: Psychotherapy

Arm 2 (Non-Therapy, Control Arm)

NO INTERVENTION

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

Interventions

Psychotherapy 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 1 (Psychotherapy, Intervention arm)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age18 years or older.
• Patients with documented diagnosis of Inflammatory Bowel Disease.
• Patients with documented need for IBD surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Jessica Gerson, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Ghoncheh.Ghiasian@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.