NCT02350920

Brief Summary

Over 18,000 Irish people are affected by the inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis. These illnesses often arise at a young age and can be associated with significant physical disability. In addition, there is considerable psychosocial disability associated with IBD. Previous studies have suggested that simple psychological interventions may be valuable in improving quality of life and may even improve disease activity. However, there has been no comprehensive trial to determine the precise effect of psychological interventions on quality of life (QOL), stress or disease activity. Our aim is to conduct a randomised controlled trial of a simple psychological intervention to determine it's effect on QOL and stress

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

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

First Submitted

Initial submission to the registry

January 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

January 20, 2015

Last Update Submit

October 10, 2018

Conditions

Inflammatory Bowel Disease

Keywords

IBDCrohn's diseaseulcerative colitisACT

Outcome Measures

Primary Outcomes (1)

  • Changes in stress measured by the Depression, Anxiety and Stress Scale (DASS 21)

    Changes in stress measured by the Depression, Anxiety and Stress Scale (DASS 21)

    20 weeks

Secondary Outcomes (5)

  • Changes in quality of life measured by the Short Health Scale (SHS)

    20 weeks

  • Changes in disease activity measured by the Short Mayo Scale and Harvey Bradshaw Index

    20 weeks

  • Changes in hair cortisol levels

    20 weeks

  • Changes in medication requirements

    20 weeks

  • Changes in General and GUT specific inflammatory markers

    20 weeks

Study Arms (2)

Acceptance and Committment Therapy (ACT)

ACTIVE COMPARATOR

This group will consist of patients who will receive ACT therapy.This intervention will run with 8-12 participants in each group for a duration of 8 weeks. Each group session will last 1-1.5 hours.

Behavioral: Acceptance and Committment Therapy (ACT)

Control

NO INTERVENTION

The control group will consist of patients who will receive no ACT therapy during the 26 week st udy period

Interventions

Acceptance and Committment Therapy (ACT)BEHAVIORAL

This intervention will run with 12-15 participants in each group for a duration of 8 weeks. Each group session will last 1-1.5 hours.

Also known as: ACT
Acceptance and Committment Therapy (ACT)

Eligibility Criteria

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

You may not qualify if:

  • Patients under 18 years,
  • Patients over 65 years,
  • pregnant females,
  • patients currently attending psychiatric services,
  • patients currently receiving antidepressant medication,
  • patients who have received steroid medications in the past three months,
  • patients who have previously undergone a stress management programme (relaxation techniques, autogenic training, psychodynamic psychotherapy, cognitive behavioural therapy, hypnosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's University Hospital

Dublin, 4, Ireland

Location

Related Publications (8)

  • Elkjaer M, Moser G, Reinisch W, Durovicova D, Lukas M, Vucelic B, Wewer V, Frederic Colombel J, Shuhaibar M, O'Morain C, Politi P, Odes S, Bernklev T, Oresland T, Nikulina I, Belousova E, Van der Eijk I, Munkholm P. IBD patients need in health quality of care ECCO consensus. J Crohns Colitis. 2008 Jun;2(2):181-8. doi: 10.1016/j.crohns.2008.02.001. Epub 2008 Apr 9.

    PMID: 21172209BACKGROUND

  • 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: 14747641BACKGROUND

  • Bitton A, Sewitch MJ, Peppercorn MA, deB Edwardes MD, Shah S, Ransil B, Locke SE. Psychosocial determinants of relapse in ulcerative colitis: a longitudinal study. Am J Gastroenterol. 2003 Oct;98(10):2203-8. doi: 10.1111/j.1572-0241.2003.07717.x.

    PMID: 14572569BACKGROUND

  • Vidal A, Gomez-Gil E, Sans M, Portella MJ, Salamero M, Pique JM, Panes J. Life events and inflammatory bowel disease relapse: a prospective study of patients enrolled in remission. Am J Gastroenterol. 2006 Apr;101(4):775-81. doi: 10.1111/j.1572-0241.2006.00476.x. Epub 2006 Feb 22.

    PMID: 16494590BACKGROUND

  • Knowles SR, Monshat K, Castle DJ. The efficacy and methodological challenges of psychotherapy for adults with inflammatory bowel disease: a review. Inflamm Bowel Dis. 2013 Nov;19(12):2704-15. doi: 10.1097/MIB.0b013e318296ae5a.

    PMID: 23846488BACKGROUND

  • Gow R, Thomson S, Rieder M, Van Uum S, Koren G. An assessment of cortisol analysis in hair and its clinical applications. Forensic Sci Int. 2010 Mar 20;196(1-3):32-7. doi: 10.1016/j.forsciint.2009.12.040. Epub 2010 Jan 21.

    PMID: 20096513BACKGROUND

  • 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

  • Wynne B, McHugh L, Gao W, Keegan D, Byrne K, Rowan C, Hartery K, Kirschbaum C, Doherty G, Cullen G, Dooley B, Mulcahy HE. Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2019 Mar;156(4):935-945.e1. doi: 10.1053/j.gastro.2018.11.030. Epub 2018 Nov 16.

    PMID: 30452919DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • hugh mulcahy, md

    UCD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Hugh Mulcahy

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

IPD will be available for other researchers following publication of of our results in the medical literature. A datafile may be obtained by contacting Prof. Hugh Mulcahy at hemulc@hotmail.com, giving details of i) proposed use of the data and ii) what form of acknowledgement of the data will be made by the researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD will be made available one month following publication, estimated to be February 2019 and will be made available for a period of five years
Access Criteria
IPD will be available as an excel file to researchers on application to Professor Hugh Mulcahy at hemulc@hotmail.com, specifying the nature of the analyses to be performed with these data and details of acknowledgements to be made regarding the data. No type of analysis will be excluded from consideration

Locations

IE(1)