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Completed

NCT Number: NCT02614014

Stress and Personality Profiles in IBD

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of health psychology. Hospital General Universitario de Alicante

Alicante, 03010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavior interventional program

Behavioral

Primary outcomes

  1. Change in IBD activity at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Number of clinical episodes of activity of IBD

  2. Change in IBD activity at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Number of hospital admisions because of IBD

  3. Change in IBD activity at short and long-term

    Time frame: 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 outcomes

  1. Change in stress scales at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Perceived Stress Scale (PSS)

  2. Change in quality of life at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Inflammatory bowel disease quality-of-life scale (IBDQ)

  3. Change in anxiety and depression at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    HAD scale

  4. Change in stress scales at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Disease related stress scale (EAE)

  5. Change in stress scales at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    Vital stressors scale (AVE)

  6. Change in stress scales at short and long-term

    Time frame: Measured at baseline, and evaluation at short-term (3 months) and long-term 12 months

    stress coping questionnaire (CAE)

Sponsors and collaborators

Lead sponsor

Asociación Española de Gastroenterología

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 25, 2015
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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