Back to resultsStress and Personality Profiles in IBD
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive-behavior interventional program
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
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
Sites / Locations
- Department of health psychology. Hospital General Universitario de Alicante
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychological intervention
Control
Arm Description
Cognitive-behavior interventional program
No intervention
Outcomes
Primary Outcome Measures
Change in IBD activity at short and long-term
Number of clinical episodes of activity of IBD
Change in IBD activity at short and long-term
Number of hospital admisions because of IBD
Change in IBD activity at short and long-term
Activity index vaules (CDAI for Crohn's disease and Mayo score for ulcerative colitis)
Secondary Outcome Measures
Change in stress scales at short and long-term
Perceived Stress Scale (PSS)
Change in quality of life at short and long-term
Inflammatory bowel disease quality-of-life scale (IBDQ)
Change in anxiety and depression at short and long-term
HAD scale
Change in stress scales at short and long-term
Disease related stress scale (EAE)
Change in stress scales at short and long-term
Vital stressors scale (AVE)
Change in stress scales at short and long-term
stress coping questionnaire (CAE)
Full Information
NCT ID
NCT02614014
First Posted
September 28, 2015
Last Updated
June 26, 2018
Sponsor
Asociación Española de Gastroenterología
1. Study Identification
Unique Protocol Identification Number
NCT02614014
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociación Española de Gastroenterología
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological intervention
Arm Type
Experimental
Arm Description
Cognitive-behavior interventional program
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavior interventional program
Primary Outcome Measure Information:
Title
Change in IBD activity at short and long-term
Description
Number of clinical episodes of activity of IBD
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in IBD activity at short and long-term
Description
Number of hospital admisions because of IBD
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in IBD activity at short and long-term
Description
Activity index vaules (CDAI for Crohn's disease and Mayo score for ulcerative colitis)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Secondary Outcome Measure Information:
Title
Change in stress scales at short and long-term
Description
Perceived Stress Scale (PSS)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in quality of life at short and long-term
Description
Inflammatory bowel disease quality-of-life scale (IBDQ)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in anxiety and depression at short and long-term
Description
HAD scale
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in stress scales at short and long-term
Description
Disease related stress scale (EAE)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in stress scales at short and long-term
Description
Vital stressors scale (AVE)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
Title
Change in stress scales at short and long-term
Description
stress coping questionnaire (CAE)
Time Frame
Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Van der Hofstadt
Organizational Affiliation
Hospital General Universitario de Alicante
Official's Role
Study Director
Facility Information:
Facility Name
Department of health psychology. Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
34069621
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.
Results Reference
derived
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Stress and Personality Profiles in IBD
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