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Cognitive Behavioural Therapy for Inflammatory Bowel Disease (iCBT Trial)
N/A
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6,12 and 24 weeks
Awards & highlights
Summary
This trial will compare an internet-based cognitive behavioural therapy intervention to usual care in reducing stress, anxiety, and depression for people with Inflammatory Bowel Disease and comorbid anxiety and/or depression.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves non-pharmaceutical therapy (iCBT), typical drug side effects aren't expected. However, participants may experience emotional discomfort addressing psychological issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with IBD (Crohn's disease or Ulcerative Colitis).
Select...
My anxiety or depression score is above 8.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently in, nor have I been in the last 3 months, cognitive behavioral therapy for anxiety or mood disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6,12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6,12 and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HADS
PSS-4
Secondary study objectives
CGI
IBDSI-SF
PROMIS-29
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
This group will receive the iCBT for IBD online intervention once enrolled.
Group II: Treatment as UsualActive Control1 Intervention
This group will be offered the iCBT for IBD intervention 24 weeks after enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioural Therapy
2002
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
612 Previous Clinical Trials
201,202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.My anxiety or depression score is above 8.We will determine if you have certain behaviors or disorders during the screening process explained in the next section.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Inflammatory Bowel Disease Patient Testimony for trial: Trial Name: NCT04700917 — N/A
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