Cognitive Behavioural Therapy for Inflammatory Bowel Disease

(iCBT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Manitoba

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are experiencing stress, anxiety, or depression. Participants must have an IBD diagnosis from a doctor, score above 8 on specific anxiety/depression scales, and have stable psychotropic medication for six weeks before joining. They need computer access and English literacy but can't join if they've had recent severe mental health issues or current/recent CBT treatment.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with IBD (Crohn's disease or Ulcerative Colitis).

My mental health medication dose has been stable for at least 6 weeks.

Exclusion Criteria

You have had thoughts about hurting yourself or have been struggling with substance abuse, mental disorders like psychosis or eating disorders within the last six months.

I am not currently in, nor have I been in the last 3 months, cognitive behavioral therapy for anxiety or mood disorders.

We will determine if you have certain behaviors or disorders during the screening process explained in the next section.

Treatment Details

Interventions

• Cognitive Behavioural Therapy (Behavioral)

Trial Overview The study tests an online cognitive behavioural therapy program designed to help people with IBD manage stress, anxiety, and depression. It's a two-arm RCT where one group receives the iCBT intervention while the other continues their usual treatment without this additional support.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Treatment as Usual Active Control 1 Intervention

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

Cognitive Behavioural Therapy is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behavioural Therapy for:

• Anxiety disorders
• Substance use disorders
• Depression
• Post-traumatic stress disorder (PTSD)
• Eating disorders

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Charles Semba

University of Manitoba

Chief Medical Officer since 2020

MD from the University of Minnesota Medical School

Rick Pauls

University of Manitoba

Chief Executive Officer since 2010

Bachelor of Arts in Economics from the University of Manitoba, MBA in Finance from the University of North Dakota