Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients

Anxiety Depression Clinical Trial

Official title:

Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04582071
• Other study ID #: 20-00275
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: August 2022

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Depression
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in participant's level of depression	Measured by PHQ-9- Patient Health Questionnaire. Questionnaire has 9 items scores each of the nine DSM-IV criteria as "0" (not at all) to "3". Subjects will achieve one out of four levels of depression severity, depending upon their scores: 0-4=minimal or none, 5-9=mild, 10-14=moderate, and 15-19=moderately severe to severe.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Change in Quality of life of participants	Measured by IBD QoL- Inflammatory Bowel Disease Quality of Life Questionnaire. Questionnaire has 32 items and the higher scores indicate better quality of life.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Increase ability to function	Measured by Work Productivity and Activity Impairment (WPAI). There is 6 items which yeilds four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism) and Activity Impairment The sum of specific health problem impairment and impairment due to other health reasons is equal to impairment due to all health reasons. WPAI outcomes are expressed as impairment percentages, multiply scores by 100 to express in percentages, with higher numbers indicating greater impairment and less productivity	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Improved self efficacy in participants	Measured by The Self-Efficacy Scale with 8 items with higher scores which will indicate greater self-efficacy.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Change in social support of participants	This will be measured by Social Support Survey which has 19 items to obtain a score for each of four subscales, calculate the average of the scores for each item in the subscale. Higher scores for an individual scale or for the overall support index indicate more support.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Improvement in coping strategies	Measured by The Brief Cope questionnaire with 28 items which are 14 subscales with 2 items each. Sum of each subscale indicates a preference for particular coping strategies, which can be characterized as either effective or less effective.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Change in the participants perception of body image	Measured by The Body Image Scale which includes 9 items. Participants score from 0 ("not at all") to 3 ("very much") on each of the 9 questions so that the lowest possible total score is 0 and the highest 27, with higher scores indicating increasing body image dissatisfaction.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Change in the participants' perception of illness	Measured by The Brief Illness Perception Questionnaire which 9 items. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Assessment of the causal representation is by an open-ended response item adapted from the IPQ-R, which asks patients to list the three most important usual factors in their illness (Item 9). Responses to the causal item can be grouped into categories such as stress, lifestyle, hereditary, etc., determined by the particular illness studied, and categorical analysis can then be performed.; The Brief IPQ allows very simple interpretation of scores: increases in item scores represent linear increases in the dimension measured.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary	Change in pain perception	Measured by Pain anxiety symptom scale short form 20 with 20 items. The PASS assesses pain-specific anxiety symptoms and consists of four 10-item subscales measuring cognitive anxiety responses, escape and avoidance, fearful thinking and physiological anxiety responses. Higher scores indicate greater anxiety symptoms.	Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)