Psychological Predictors in Colorectal IBD Surgery Recovery

Inflammatory Bowel Diseases Clinical Trial

— MIND-IBD  

Official title:

Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893942
• Other study ID #: 2214
• Status: Active, not recruiting
• Start date: April 16, 2019
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for Inflammatory Bowel Diseases (IBD), including Crohn's disease and Ulcerative Colitis.

Description:

The chronic nature of Inflammatory Bowel Disease (IBD) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. The sequelae of this can be seen in the increased rates of depression and reduced quality of life (QoL). Surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. Over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. Some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. Nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. We suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2021
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years old (both males and females).

• Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis).

• Patients scheduled for elective open or laparoscopic surgery for curative intent.

Exclusion Criteria:

• Patients unable to give the written informed consent.

• Patients < 18 years old.

• Patients undergoing surgery in emergency setting.

• Patients with pre-operative evidence of colorectal cancer or High Grade/Low grade dysplasia.

• Pregnant or breastfeeding patients.

• Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Questionnaires administration
Psychological and quality of life questionnaires
• Langer Mindfulness Scale (LMS)
The LMS is a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
• Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item questionnaire, designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
• Cognitive Flexibility Scale (CFS)
The CFS is 12-item self-report test assessing awareness.
• Life Orientation Test (LOT)
The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
• Mini Locus of Control test (MLS)
The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
• Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
• Perceived Stress Scale (PSS)
The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between psychological predictors questionnaires outcome and length of hospital stay	Length of stay calculated in days from the day of surgery until the day of discharge	Post-operative day 7
Primary	Correlation between psychological predictors questionnaires outcome and quality of life	Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)	Post-operative day 30
Primary	Correlation between psychological predictors questionnaires outcome and quality of life	Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)	Post-operative day 90
Primary	Correlation between psychological predictors questionnaires outcome and quality of life	Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)	Post-operative month 6
Primary	Correlation between psychological predictors questionnaires outcome and quality of life	Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)	Post-operative month 12