Inflammatory Bowel DiseaseNCT03852745
Managing Stress With Inflammatory Bowel Disease
A study testing Cognitive Behavioral Therapy in people with Inflammatory Bowel Disease and Anxiety, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will recruit persons with Inflammatory Bowel Disease. The investigators will contact people in an ongoing study (called IMAGINE) to recruit persons with high levels of stress, anxiety, or depression who are interested in a web-based program focused on skills in managing stress, anxiety and depression (a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Anxiety, Depression
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis
- A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem
- Regular access to a personal computer and Internet to allow access to the program
- Ability to read and write English
Who cannot join
- Presence of significant suicidal ideation or suicidal intent within the last six months
- Presence of self-harming behavior in the last six months
- Currently active substance use disorder (last six months)
- Psychotic disorder (last six months)
- Eating disorder (last six months)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba - College of Medicine
Winnipeg, Manitoba, R3E 0W2
About this study
Official title: Managing Stress With Inflammatory Bowel Disease - an Open Trial of a Web-based Intervention
This study will recruit persons with Inflammatory Bowel Disease. The investigators will contact people in an ongoing study (called IMAGINE) to recruit persons with high levels of stress, anxiety, or depression who are interested in a web-based program focused on skills in managing stress, anxiety and depression (a self-directed psychosocial intervention). The goal is to develop an internet-based psychosocial intervention to help persons with inflammatory bowel disease to cope with high levels of stress, anxiety or depression.
Read the detailed description
Depression and anxiety are highly prevalent in IBD, with depression rates almost twice as high for those with IBD compared to the general community, and an estimated 30% overall with depression or anxiety. Perceived stress is a factor in the development of anxiety and depression. These comorbid conditions complicate management of IBD, adversely impacting patient outcomes and health, and increasing the resource burden to the health care system. However, comorbid depression and anxiety in IBD patients is undertreated, paralleling unmet mental health treatment needs in the general Canadian population. Development of alternate modes of effective treatment delivery is vital to enhance access, given limited mental health service availability. CBT has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses. CBT may be successfully delivered as an internet-based intervention. While there are limited data on the efficacy of CBT tailored to the IBD population, studies targeting comorbid depression in IBD have resulted in significant mental health improvement. A recent study described an internet-based CBT for IBD reported modest outcomes (150), but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms. The internet-based program used in this study will involve brief modules focused on areas important in managing stress, anxiety and depression including:
Core Topics: 1. About the Program, 2. IBD and Stress 3. Commitment to Living Life Fully, 4. The Brain-Gut Connection, 5. Understanding Anxiety, 6. Overcoming Avoidance, 7. Depression, 8. Behavioural Activation; Optional Topics: 9. Treatment Options, 10. IBD and the Workplace 11. Mindfulness
Procedures: Participants will be recruited with the use of a resources informing possible participants about the project. Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it. They will be asked to schedule a time with the study coordinator to review with consent form, discuss any questions about the consent form or the program, and at the end to indicate verbally whether or not they provide consent. Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria. The interview used will be the Mini International Neuropsychiatric Interview (MINI) for DSM5. Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the program.Once participants are accepted into the study assessments will be completed at baseline, week 6, week 12, and during follow up at week 24.
- Conditions
- Inflammatory Bowel Disease, Anxiety, Depression
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- cognitive behavioral therapy, online intervention
- Medical subject headings
- Inflammatory Bowel Diseases, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
cognitive behavioral therapy; focus on learning skills including acceptance and commitment
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Other | Online cognitive behavioral therapy intervention for 2 hours a week for 12 weeks. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
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
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes (4)
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
scale measuring health-related quality of life (29 items); likert scale 1 to 5, varying anchor points; in symptom oriented domains higher scores represent worse symptomology and in function oriented domains higher scores represent better functioning
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in Clinical Global Impression - Improvement scale (CGI-I)
scale measuring confidence in ability to manage stress (2 items); likert scale with varying anchor points; higher scores indicate higher stress and lower confidence
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in the Work and Social Adjustment Scale (WSAS)
scale measuring how inflammatory bowel disease impact daily functioning; likert scale 1(not at all) to 5 (very severely); higher scores indicate higher levels higher functional impairment
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)
scale measuring symptoms of inflammatory bowel disease; likert scale with varying anchor points
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start18 Apr 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cognitive behavior therapy
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Furer, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852745
- Sponsor's protocol ID
- H2018:333
- Other IDs
- H2017:228
- Status last verified
- Nov 2020
- First submitted
- 1 Aug 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Stress With Inflammatory Bowel Disease - an Open Trial of a Web-based Intervention
- ClinicalTrials.gov ID
- NCT03852745
- Acronym / sponsor ID
- H2018:333
- Conditions
- Inflammatory Bowel Disease, Anxiety, Depression
- Keywords
- cognitive behavioral therapy, online intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit persons with Inflammatory Bowel Disease. The investigators will contact people in an ongoing study (called IMAGINE) to recruit persons with high levels of stress, anxiety, or depression who are interested in a web-based program focused on skills in managing stress, anxiety and depression (a self-directed psychosocial intervention). The goal is to develop an internet-based psychosocial intervention to help persons with inflammatory bowel disease to cope with high levels of stress, anxiety or depression.
Detailed description
Depression and anxiety are highly prevalent in IBD, with depression rates almost twice as high for those with IBD compared to the general community, and an estimated 30% overall with depression or anxiety. Perceived stress is a factor in the development of anxiety and depression. These comorbid conditions complicate management of IBD, adversely impacting patient outcomes and health, and increasing the resource burden to the health care system. However, comorbid depression and anxiety in IBD patients is undertreated, paralleling unmet mental health treatment needs in the general Canadian population. Development of alternate modes of effective treatment delivery is vital to enhance access, given limited mental health service availability. CBT has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses. CBT may be successfully delivered as an internet-based intervention. While there are limited data on the efficacy of CBT tailored to the IBD population, studies targeting comorbid depression in IBD have resulted in significant mental health improvement. A recent study described an internet-based CBT for IBD reported modest outcomes (150), but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms. The internet-based program used in this study will involve brief modules focused on areas important in managing stress, anxiety and depression including:
Core Topics: 1. About the Program, 2. IBD and Stress 3. Commitment to Living Life Fully, 4. The Brain-Gut Connection, 5. Understanding Anxiety, 6. Overcoming Avoidance, 7. Depression, 8. Behavioural Activation; Optional Topics: 9. Treatment Options, 10. IBD and the Workplace 11. Mindfulness
Procedures: Participants will be recruited with the use of a resources informing possible participants about the project. Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it. They will be asked to schedule a time with the study coordinator to review with consent form, discuss any questions about the consent form or the program, and at the end to indicate verbally whether or not they provide consent. Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria. The interview used will be the Mini International Neuropsychiatric Interview (MINI) for DSM5. Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the program.Once participants are accepted into the study assessments will be completed at baseline, week 6, week 12, and during follow up at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cognitive behavior therapy
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Other | Behavioral: Cognitive Behavioral TherapyOnline cognitive behavioral therapy intervention for 2 hours a week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis
- A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem
- Regular access to a personal computer and Internet to allow access to the program
- Ability to read and write English
Key exclusion criteria (5 listed)
- Presence of significant suicidal ideation or suicidal intent within the last six months
- Presence of self-harming behavior in the last six months
- Currently active substance use disorder (last six months)
- Psychotic disorder (last six months)
- Eating disorder (last six months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapycognitive behavioral therapy; focus on learning skills including acceptance and commitment | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
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
Change in Perceived Stress Scale 4 (PSS-4)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress
4 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in Clinical Global Impression - Improvement scale (CGI-I)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in the Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Furer, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Inflammatory Bowel Disease and Anxiety, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline, 6 weeks, 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.