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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6,12 and 24 weeks
Awards & highlights

iCBT Trial 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.Check my eligibility
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.See study design
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.

iCBT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with IBD (Crohn's disease or Ulcerative Colitis).
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My anxiety or depression score is above 8.

iCBT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6,12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6,12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HADS
PSS-4
Secondary outcome measures
CGI
IBDSI-SF
PROMIS-29
+1 more

iCBT Trial 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
2016
Completed Phase 3
~3800

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,129 Total Patients Enrolled

Media Library

Cognitive Behavioural Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04700917 — N/A
Inflammatory Bowel Disease Research Study Groups: Intervention Group, Treatment as Usual
Inflammatory Bowel Disease Clinical Trial 2023: Cognitive Behavioural Therapy Highlights & Side Effects. Trial Name: NCT04700917 — N/A
Cognitive Behavioural Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04700917 — N/A
Inflammatory Bowel Disease Patient Testimony for trial: Trial Name: NCT04700917 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open vacancies for participants in this experiment?

"Clinicaltrials.gov lists this medical study as still actively recruiting participants, which it has been doing since March 16 2021 - the date of its initial posting. It was last updated on March 28 2022."

Answered by AI

What aims does this experiment seek to fulfill?

"This trial will assess the effectiveness of PSS-4 as primary outcome over baseline, 6 weeks, 12 weeks and 24 weeks. Other objectives include tracking Change in Clinical Global Impression - Improvement scale (CGI-I), Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI) severity levels and Work and Social Adjustment Scale (WSAS) functionality impacts through likert scales with varying anchor points. Higher scores indicate higher stress or functional impairment from IBD symptoms respectively."

Answered by AI

How many subjects are included in this research endeavor?

"Affirmative. The details listed on clinicaltrials.gov denote that this experiment is accepting participants at the moment and was originally posted on March 16th 2021, with the latest amendment being made on March 28th 2022. Accordingly, 352 volunteers are necessary from a single facility."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Because I have all the symptoms for the trial, and I saw that it was an online/at home study.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Internet-Based Cognitive Behavioural Program for Managing Stress With IBD: An RCT
Patricia Furer 2021. "Internet-Based Cognitive Behavioural Program for Managing Stress With IBD: An RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04700917.
All > Inflammatory Bowel Disease > Ibd
~56 spots leftby Dec 2024
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