Stress and Personality Profiles in IBD

Asociación Española de Gastroenterología

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Behavioral: Cognitive-behavior interventional program

Study type: Interventional

Funder types: Other

Identifiers

NCT02614014

PSI-EII-09

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Psychological intervention

Experimental group

Description:

Cognitive-behavior interventional program

Treatment:

Behavioral: Cognitive-behavior interventional program

Control

No Intervention group

Description:

No intervention