Clinical trial NCT02614014: Stress and Personality Profiles in IBD
Official title: Effect of the Stress and Personality Profiles in the Development, Evolution and Treatment of Inflammatory Bowel Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: Asociación Española de Gastroenterología
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in IBD activity at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in IBD activity at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in IBD activity at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary outcomes:
measure: Change in stress scales at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in quality of life at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in anxiety and depression at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in stress scales at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in stress scales at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
measure: Change in stress scales at short and long-term
timeFrame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Department of health psychology. Hospital General Universitario de Alicante
Study officials:
affiliation: Hospital General Universitario de Alicante
name: Carlos Van der Hofstadt
role: STUDY_DIRECTOR
References:
citation: Bernabeu P, van-der Hofstadt C, Rodriguez-Marin J, Gutierrez A, Alonso MR, Zapater P, Jover R, Sempere L. Effectiveness of a Multicomponent Group Psychological Intervention Program in Patients with Inflammatory Bowel Disease: A Randomized Trial. Int J Environ Res Public Health. 2021 May 19;18(10):5439. doi: 10.3390/ijerph18105439.