Recruiting

Cognitive Behavioural Program

Sponsor:

University of Manitoba

Code:

NCT04700917

Conditions

Inflammatory Bowel Diseases

Anxiety

Depression

Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy

Study Details

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).

Conditions

Inflammatory Bowel Diseases

Anxiety

Depression

Stress

Study ID

NCT04700917

Start date

Mar 16, 2021

Status verified date

May, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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

no intervention: Treatment as Usual

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

Interventions

Cognitive Behavioural Therapy

Internet-Based CBT

Primary outcome measure

  • PSS-4 [ Time Frame: Baseline, 6, 12 and 24 weeks ]
  • HADS [ Time Frame: Baseline, 6, 12 and 24 weeks ]

Central Contacts and Locations

Central contacts

Patricia Furer, PhD.

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

Gia Ly, MSc.

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

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Gia Ly Jackson, MSc.

204-787-4799ibdstresskit@umanitoba.ca

Shelby Anderson, BA

204-787-4799ibdresearch@exchange.hsc.mb.ca

Principal Investigator:

Patrica Furer, PhD

More Information

Sponsor

University of Manitoba

Last update posted

May 11, 2023

Last verified

May, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2023-05-11.