Clinical trial NCT04582071: Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
Official title: Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in State - based anxiety
timeFrame: 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:
measure: Change in participant's level of depression
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Change in Quality of life of participants
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Increase ability to function
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Improved self efficacy in participants
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Change in social support of participants
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Improvement in coping strategies
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Change in the participants perception of body image
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Change in the participants' perception of illness
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
measure: Change in pain perception
timeFrame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Jessica Gerson, MD
role: PRINCIPAL_INVESTIGATOR
References: