Prevalence of Neuropsychiatric Manifestations in IBD Patients in Upper Egypt

NCT04573400 | Unknown

• 1 other identifier: IBD and neuropsychiatry
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Estimation of neuropsychiatric symptoms prevalence in IBD patients and their impact on quality of life.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Identify prevalence of neurological and psychological conditions associated with IBD.

  2021-2022

Interventions

HADS OTHER

The HADS is a 14-item self-report questionnaire assessing levels of anxiety (seven items) and depression (seven items) over the past week. Each question is assessed on a 4-point Likert Scale: "I feel tense or 'wound up'" (0= not at all 3= most of the time). Consistent with recommendations by Bjelland et al cut-off of 8 for each HADS subscale will be used to differentiate normal from mild to severe distress.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years

You may qualify if:

• patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years, and able to complete the examination and questionnaire.

You may not qualify if:

• Patients under the age of 18.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.

  PMID: 17499605 BACKGROUND

• Danese S, Semeraro S, Papa A, Roberto I, Scaldaferri F, Fedeli G, Gasbarrini G, Gasbarrini A. Extraintestinal manifestations in inflammatory bowel disease. World J Gastroenterol. 2005 Dec 14;11(46):7227-36. doi: 10.3748/wjg.v11.i46.7227.

  PMID: 16437620 BACKGROUND

• Benavente L, Moris G. Neurologic disorders associated with inflammatory bowel disease. Eur J Neurol. 2011 Jan;18(1):138-43. doi: 10.1111/j.1468-1331.2010.03095.x.

  PMID: 20500801 BACKGROUND

• Graff LA, Walker JR, Bernstein CN. Depression and anxiety in inflammatory bowel disease: a review of comorbidity and management. Inflamm Bowel Dis. 2009 Jul;15(7):1105-18. doi: 10.1002/ibd.20873.

  PMID: 19161177 BACKGROUND

• Porcelli P, Zaka S, Centonze S, Sisto G. Psychological distress and levels of disease activity in inflammatory bowel disease. Ital J Gastroenterol. 1994 Apr;26(3):111-5.

  PMID: 8061336 BACKGROUND

• Mittermaier C, Dejaco C, Waldhoer T, Oefferlbauer-Ernst A, Miehsler W, Beier M, Tillinger W, Gangl A, Moser G. Impact of depressive mood on relapse in patients with inflammatory bowel disease: a prospective 18-month follow-up study. Psychosom Med. 2004 Jan-Feb;66(1):79-84. doi: 10.1097/01.psy.0000106907.24881.f2.

  PMID: 14747641 BACKGROUND

• Mardini HE, Kip KE, Wilson JW. Crohn's disease: a two-year prospective study of the association between psychological distress and disease activity. Dig Dis Sci. 2004 Mar;49(3):492-7. doi: 10.1023/b:ddas.0000020509.23162.cc.

  PMID: 15139504 BACKGROUND

MeSH Terms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-09