Inflammatory Bowel DiseasesMIND-IBDNCT03893942
Psychological Predictors in Colorectal IBD Surgery Recovery
An observational study of Inflammatory Bowel Diseases, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Questionnaires administration, Langer Mindfulness Scale (LMS) and Mindful Attention Awareness Scale (MAAS)
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2019to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) scheduled for elective curative colorectal surgery.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
Rozzano, MI, 20089
About this study
Official title: Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study
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.
Read the detailed 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Questionnaires administration, Langer Mindfulness Scale (LMS), Mindful Attention Awareness Scale (MAAS), Cognitive Flexibility Scale (CFS), Life Orientation Test (LOT)
- Keywords
- Inflammatory Bowel Diseases, Mindfulness, Psychological predictors, Colorectal surgery
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires administrationOther
Psychological and quality of life questionnaires
Langer Mindfulness Scale (LMS)Other
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)Other
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)Other
The CFS is 12-item self-report test assessing awareness.
Life Orientation Test (LOT)Other
The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
Mini Locus of Control test (MLS)Other
The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
Hospital Anxiety and Depression Scale (HADS)Other
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)Other
The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-operative day 7
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)
Measured: Post-operative day 30
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)
Measured: Post-operative day 90
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)
Measured: Post-operative month 6
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)
Measured: Post-operative month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start16 Apr 2019
- Primary completion25 Oct 2020
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893942
- Sponsor's protocol ID
- 2214
- Acronym
- MIND-IBD
- Status last verified
- Feb 2021
- First submitted
- 26 Mar 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT03893942
- Acronym / sponsor ID
- MIND-IBD / 2214
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, Mindfulness, Psychological predictors, Colorectal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) scheduled for elective curative colorectal surgery.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires administrationPsychological and quality of life questionnaires | Other | – |
| 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. | Other | – |
| 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 | Other | – |
| Cognitive Flexibility Scale (CFS)The CFS is 12-item self-report test assessing awareness. | Other | – |
| Life Orientation Test (LOT)The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes. | Other | – |
| Mini Locus of Control test (MLS)The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality. | Other | – |
| 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 | Other | – |
| 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. | Other | – |
Primary outcome
Correlation between psychological predictors questionnaires outcome and length of hospital stay
Time frame: Post-operative day 7
Length of stay calculated in days from the day of surgery until the day of discharge
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative day 30
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative day 90
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative month 6
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life
Time frame: Post-operative month 12
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Spinelli, MD, PhD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between psychological predictors questionnaires outcome and length of hospital stay (time frame: Post-operative day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.