Stress and Personality Profiles in IBD

NCT ID: NCT02614014

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Psychological intervention

Cognitive-behavior interventional program

Group Type EXPERIMENTAL

Cognitive-behavior interventional program

Intervention Type BEHAVIORAL

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive-behavior interventional program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asociación Española de Gastroenterología

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carlos Van der Hofstadt

Role: STUDY_DIRECTOR

Hospital General Universitario de Alicante

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of health psychology. Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type DERIVED
PMID: 40243391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34069621 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSI-EII-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.