NCT02614014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

September 28, 2015

Last Update Submit

June 26, 2018

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (3)

  • Change in IBD activity at short and long-term

    Number of clinical episodes of activity of IBD

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

  • Change in IBD activity at short and long-term

    Number of hospital admisions because of IBD

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

  • Change in IBD activity at short and long-term

    Activity index vaules (CDAI for Crohn's disease and Mayo score for ulcerative colitis)

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

Secondary Outcomes (6)

  • Change in stress scales at short and long-term

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

  • Change in quality of life at short and long-term

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

  • Change in anxiety and depression at short and long-term

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

  • Change in stress scales at short and long-term

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

  • Change in stress scales at short and long-term

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

  • +1 more secondary outcomes

Study Arms (2)

Psychological intervention

EXPERIMENTAL

Cognitive-behavior interventional program

Behavioral: Cognitive-behavior interventional program

Control

NO INTERVENTION

No intervention

Interventions

Cognitive-behavior interventional programBEHAVIORAL
Psychological intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years
  • Informed consent
  • Crohn's disease or ulcerative colitis diagnosis
  • Active disease in the last 18 months

You may not qualify if:

  • Severe mental disease
  • Other severe concomitant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of health psychology. Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Related Publications (2)

  • 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.

    PMID: 40243391DERIVED

  • 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.

    PMID: 34069621DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Carlos Van der Hofstadt

    Hospital General Universitario de Alicante

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

November 25, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

ES(1)