Stress and Personality Profiles in IBD

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Behavioral: Cognitive-behavior interventional program

• Registration Number: NCT02614014
• Lead Sponsor: Asociación Española de Gastroenterología

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Primary Completion: 2016-06
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychological intervention	Cognitive-behavior interventional program	Cognitive-behavior interventional program

Primary Outcome Measures

Name	Time	Method
Change in IBD activity at short and long-term	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)

Secondary Outcome Measures

Name	Time	Method
Change in stress scales at short and long-term	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months	stress coping questionnaire (CAE)
Change in quality of life at short and long-term	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months	Inflammatory bowel disease quality-of-life scale (IBDQ)
Change in anxiety and depression at short and long-term	Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months	HAD scale

Trial Locations

Locations (1)

Department of health psychology. Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain