NCT04700917

Brief Summary

The study will examine the efficacy of an internet-based cognitive behavioural therapy (iCBT) for Inflammatory Bowel Disease (IBD) intervention to reduce stress, anxiety, and depression in individuals with IBD and comorbid clinically elevated t anxiety and/or depressive symptoms. The investigators will conduct a two-arm RCT comparing participants receiving the iCBT intervention (intervention group) and those receiving Treatment As Usual (TAU).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.7 years

First QC Date

January 6, 2021

Last Update Submit

May 9, 2023

Conditions

Inflammatory Bowel DiseasesAnxietyDepressionStress

Keywords

Inflammatory Bowel Disease, Anxiety, Depression, Stress, Online Intervention

Outcome Measures

Primary Outcomes (2)

  • PSS-4

    Change in Perceived Stress Scale 4 (PSS-4) scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress

    Baseline, 6, 12 and 24 weeks

  • HADS

    Change in Hospital Anxiety and Depression Scale (HADS) scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression

    Baseline, 6, 12 and 24 weeks

Secondary Outcomes (4)

  • PROMIS-29

    Baseline, 6, 12 and 24 weeks

  • WSAS

    Baseline, 6, 12 and 24 weeks

  • IBDSI-SF

    Baseline, 6, 12 and 24 weeks

  • CGI

    Baseline, 6,12 and 24 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will receive the iCBT for IBD online intervention once enrolled.

Behavioral: Cognitive Behavioural Therapy

Treatment as Usual

NO INTERVENTION

This group will be offered the iCBT for IBD intervention 24 weeks after enrollment.

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

Internet-Based CBT

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Participants will need to be at least 18 years of age or older, be diagnosed by a physician with IBD (Crohn's disease or Ulcerative Colitis), have anxiety and/or depression scores \> 8 on the Hospital Anxiety and Depression Scale (HADS-A or HADS-D), have access to a computer, and be literate in the English language. Participants may be on psychotropic medication but dosage should be stable for at least six weeks prior to study enrollment.

You may not qualify if:

  • Individuals who have had, within the last six months, suicidal ideation or suicidal intent, self-harming behaviour, active substance use disorder, psychotic disorder, or an eating disorder will be excluded. Presence of these behaviours and disorders will be determined through the screening process described in the next section. Individuals who are currently receiving cognitive behavioral treatment for an anxiety or mood disorder, or have participated in such treatment in the previous three months, are not eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Related Publications (1)

  • 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

MeSH Terms

Conditions

Inflammatory Bowel DiseasesAnxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Patricia Furer, PhD.

CONTACT

204-237-2335pfurer@sbgh.mb.ca

Gia Ly, MSc.

CONTACT

204-787-4799giave.ly@umanitoba.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 8, 2021

Study Start

March 16, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)