Stress and Personality Profiles in IBD

June 26, 2018 updated by: Asociación Española de Gastroenterología

Effect of the Stress and Personality Profiles in the Development, Evolution and Treatment of Inflammatory Bowel Disease.

Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (IBD) and the quality of life of these patients. A second aim is to establish the existence of any psicopathological profile in these patients. We designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. Patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to IBD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Department of health psychology. Hospital General Universitario de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-85 years
  • Informed consent
  • Crohn's disease or ulcerative colitis diagnosis
  • Active disease in the last 18 months

Exclusion Criteria:

  • Severe mental disease
  • Other severe concomitant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Psychological intervention
Cognitive-behavior interventional program
Behavioral: Cognitive-behavior interventional program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IBD activity at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Number of clinical episodes of activity of IBD
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in IBD activity at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Number of hospital admisions because of IBD
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in IBD activity at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Activity index vaules (CDAI for Crohn's disease and Mayo score for ulcerative colitis)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stress scales at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Perceived Stress Scale (PSS)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in quality of life at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Inflammatory bowel disease quality-of-life scale (IBDQ)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in anxiety and depression at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
HAD scale
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in stress scales at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Disease related stress scale (EAE)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in stress scales at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Vital stressors scale (AVE)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Change in stress scales at short and long-term
Time Frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
stress coping questionnaire (CAE)
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación Española de Gastroenterología

Investigators

  • Study Director: Carlos Van der Hofstadt, Hospital General Universitario de Alicante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSI-EII-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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