Stress and Personality Profiles in IBD

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614014
• Other study ID #: PSI-EII-09
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: Asociación Española de Gastroenterología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Cognitive-behavior interventional program

Locations

Country	Name	City	State
Spain	Department of health psychology. Hospital General Universitario de Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Asociación Española de Gastroenterología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IBD activity at short and long-term	Number of clinical episodes of activity of IBD	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Primary	Change in IBD activity at short and long-term	Number of hospital admisions because of IBD	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Primary	Change in IBD activity at short and long-term	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	Change in stress scales at short and long-term	Perceived Stress Scale (PSS)	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary	Change in quality of life at short and long-term	Inflammatory bowel disease quality-of-life scale (IBDQ)	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary	Change in anxiety and depression at short and long-term	HAD scale	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary	Change in stress scales at short and long-term	Disease related stress scale (EAE)	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary	Change in stress scales at short and long-term	Vital stressors scale (AVE)	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary	Change in stress scales at short and long-term	stress coping questionnaire (CAE)	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months