An interventional study of Web-Based Cognitive Behavioral Therapy and Short Questionnaires in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by Mount Sinai Hospital, Canada. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Mount Sinai Hospital, Canada · Not applicable, Interventional, and Health services research
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Among 155 studies in Inflammatory Bowel Diseases with a site in Canada — 35 open to participants now, 49 under way, 6 of them phase 3. Inflammatory Bowel Diseases · Canada.
Among the 155 studies in Inflammatory Bowel Diseases with a site in Canada, this one is the 43rd largest by planned enrollment of the 118 interventional ones that give a count, is one of 11 that started in 2018, is one of 45 with no phase, and was the 75th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.
Browse Inflammatory Bowel Diseases studies →35 of the 155 studies in Inflammatory Bowel Diseases with a site in Canada are open now. Recruiting first, the newest first:
Palisade Bio · Sites in Canada, United States, Czechia and 9 more countries
Ages 18–75
Eli Lilly and Company · Sites in Canada, United States, Denmark and 4 more countries
Ages 3 wk+ · Women only
University of British Columbia · Sites in Canada
Ages 9–17
University of British Columbia · Sites in Canada
Ages 19+ · Women only · Healthy volunteers
University of Alberta · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 33 · Phase 3 28 · Phase 4 10
First in 2002; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Median enrollment 121 across the 118 interventional studies, 157 across the 36 observational. Of the 91 that completed or were terminated, 32 (35%) have results posted.
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61 of 155 have an industry lead sponsor. The 10 most frequent:
Mount Sinai Hospital, Canada is the lead sponsor of 158 studies on the registry; 32 are open to participants now.
Mount Sinai Hospital, Canada has 8 studies filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
15 of the studies in Inflammatory Bowel Diseases with a site in Canada that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07434310Phase 3Dr. Naveed SiddiquiUse of Dexmedetomidine to Improve Pain Control and Recovery After Laparocopic-Assisted Bowel Surgery in Adults | 2027-07-01 |
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT07814274University of British ColumbiaProspective Intestinal Ultrasound Study for Artificial Intelligence Algorithm Development | 2027-02-01 |
| NCT05722236Jennifer JonesIBD Strong Peer2Peer for Self-Management of Psychological Distress | 2027-03 |
| NCT06548399McMaster UniversityLongitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease | 2027-03-30 |
Add all 15 to your calendar (.ics) → With an account.
Among the 155 studies in Inflammatory Bowel Diseases with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per 100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the second and third decades of life, at a time when vulnerable individuals are entering the prime years of their lives. This age of onset, coupled with the recurrent and frequently relapsing nature of these disorders, can significantly impair the psychological well-being of patients. Therefore, it's not surprising that patients with IBD report a higher burden of depression and anxiety in comparison to the general population. The prevalence of depression and anxiety in patients with IBD have previously been linked to the following: (1) Increased risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and medication adherence; (6) and Increased health care utilization. Although, depression and anxiety are highly treatable conditions, they are often under-recognized and under- treated in patients with IBD. The most common treatments for these disorders are pharmacological agents and psychological treatments. Psychological treatments like Cognitive Behavioral Therapy (CBT) have extensive support for treatment of depression and anxiety. The major advantage of psychological treatments over pharmacological agents is their ability to sustain improved depression and anxiety symptoms in patients post-treatment. As part of this study, we aim to evaluate the following:
Specific Aim #1: Determine whether a psychological intervention, involving web-based CBT, is effective in ameliorating depression and anxiety symptoms in a cohort of adult IBD patients.
Specific Aim #2: Determine the durability effect of the intervention on sustaining improved psychiatric symptoms.
Specific Aim #3: Determine the impact of a psychological on IBD-specific and psychiatric-specific health care utilization.
Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per 100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the second and third decades of life; at a time when vulnerable individuals are entering the prime years of their lives. This age of onset, coupled with the recurrent and frequently relapsing nature of these disorders, can significantly impair the psychological well-being of patients. Therefore, it's not surprising that patients with IBD report a higher burden of depression and anxiety in comparison to the general population.
The rates of depression in patients with IBD, as measured by the National Population Health Survey and the Canadian Community Health Survey, range from 14.7% to 16.3%. These rates are significantly higher than the general Canadian population, in which 5.6% of healthy respondents reported a 12-month prevalence of depression. Moreover, studies among clinical samples of IBD patients have reported rates of depression as high as 35%. The prevalence of depression and anxiety in patients with IBD have previously been linked to the following: (1) Increased risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and medication adherence; (6) and Increased health care utilization.
Although, depression and anxiety are highly treatable conditions, they are often under recognized and under treated in patients with IBD. The most common treatments for these disorders are pharmacological agents and psychological treatments. Psychological treatments like Cognitive Behavioral Therapy (CBT) have extensive support for treatment of depression and anxiety. CBT refers to a group of interventions that share the notion that cognitive factors influence mental disorders and psychological distress, and that maladaptive cognitions contribute to emotional distress and behavioral problems. The major advantage of psychological treatments over pharmacological agents is their ability to sustain improved depression and anxiety symptoms in patients post-treatment.
Considering the prevalence and impact of depression and anxiety disorders in patients with IBD, further research in this area is needed to identify the most effective approaches for screening and treatment of these disorders. Research is also need to ascertain the effects of psychological treatments for depression and anxiety on influencing physiological aspects of IBD. As part of this study, we aim to evaluate the effectiveness of a psychological intervention which incorporates web-based CBT intervention on a cohort of adult IBD patients; by measuring its impact on clinical and self-reported outcomes.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be randomized to the intervention group after they have complete the study screening form. Patients randomized to the intervention group will receive a multifaceted intervention consisting of the following components (administered over an 8 week period): (1) Web-Based Cognitive Behavioral Therapy: (2) Short Questionnaires; (3) Ongoing Nurse Monitoring.
Behavioral: Web-Based Cognitive Behavioral Therapy · Other: Short Questionnaires · Behavioral: Nurse Monitoring · Other: Detailed Questionnaires · Other: Screening Form
Patients will be randomized to the control group after they have completed the study screening form. Patients randomized to the control group will receive the usual standard of care that is available to patients with moderate anxiety or depression. Additionally, control patients will completed detailed questionnaires for assessment of primary and secondary outcomes.
Other: Detailed Questionnaires · Other: Screening Form
Patients will receive access to a 5-week web-based CBT program entitled 'Mood Gym'. The program is derived from traditional, therapist-directed cognitive behavioral therapy. The program consists of 5 modules, and patients will asked to complete 1 module per week over, during weeks 2-6 over their intervention period.
Patients will receive emails to complete bi-weekly, web-based questionnaires at weeks 2, 4, and 6 of their intervention period. The short questionnaires will ask to patients to self-report their Depression (PHQ-9) and Anxiety (GAD-7) symptoms; along with their Crohn's Disease activity (PRO-2) or Ulcerative Colitis Disease Activity (MAYO-6).
Patient responses to the short questionnaires will be monitored by an IBD advanced practice nurse. The IBD nurse will determine if there are elevations in anxiety, depression, and disease activity over the intervention period. Based on patient responses to the short questionnaires, the nurse will follow-up with patients via email or telephone to address patient symptoms. If there are clinically important changes in the patients' disease activity the nurse may also arrange for the patients to receive expedited outpatient follow-up with their gastroenterologist.
Patients will complete a detailed questionnaires at enrollment (i.e. week 1 of enrollment) and also at post-intervention (i.e. week 8 of enrollment). The enrollment questionnaire will query the patients Ulcerative Colitis Disease Activity (MAYO-6) or Crohn's Disease Activity (PRO-2); Quality of Life (SIBDQ); and Patient Satisfaction with Health Care in IBD (CACHE). The post-intervention questionnaire will query the same information as the enrollment questionnaire but will also ask patients to self-report their depression (PHQ-9) and anxiety (GAD-7) symptoms.Quality of Life will be measured using the 10 item Short Inflammatory Bowel Disease Questionnaire (SIBDQ), which has a total score range of 10 to 70, with higher scores indicating better quality of life. Patient Satisfaction with Health Care in IBD will be measured using the 32 item CACHE Questionnaire, which scores from 0 -least satisfaction to 100-highest satisfaction.
Patients will complete a screening form at routine IBD outpatient visits to Mount Sinai Hospital to self-report their depression and generalized anxiety symptoms. Their depression symptoms will be reported on the 9-item Patient Health Questionnaire (PHQ-9), which has a total score ranging from 0 to 27, with scores of 5, 10, 15 and 20 representing cut points for mild, moderate, moderately severe, and severe depression. Their generalized anxiety symptoms will be reported on the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7), which has a total score ranging from 0 to 21, with scores of 5, 10, and 15 representing cut points for mild, moderate, and severe anxiety. Patients who self-report scores of moderate depression AND/OR moderate anxiety will be eligible to participate in this study.
Rates of Moderate Depression (PHQ-9)
Post-intervention rates will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Rates of Moderate Anxiety (GAD-7)
Post-intervention rates will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Rates of Moderate Depression (PHQ-9) and co-morbid Anxiety (GAD-7)
Post-intervention rates will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Difference in Depression Scores (PHQ-9)
Post-intervention Patient Health Questionnaire (PHQ-9) scores will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Difference in Anxiety Scores (GAD-7)
Post-intervention Generalized Anxiety Disorder (GAD-7) scores will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Change in Depression Scores (PHQ-9)
Change in Patient Health Questionnaire (PHQ-9) scores between enrollment and post-intervention will be compared within study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Change in Anxiety Scores (GAD-7)
Change in Generalized Anxiety Disorder (GAD-7) scores between enrollment and post-intervention will be compared within study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Rates of Active IBD (PRO-2 or MAYO-6)
Post-intervention rates will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Rates of Active IBD (PRO-2 or MAYO-6)
Change in rates between enrollment and post-intervention will be compared within study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Difference in Quality of Life Scores (SIBDQ)
Post-intervention Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Difference in Patient Satisfaction Scores (CACHE)
Post-intervention Patient Satisfaction with Health Care in IBD (CACHE) scores will be compared between study groups
Time frame: Post-Intervention (i.e. week 8)
Change in Quality of Life Scores (SIBDQ)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores between enrollment and post-intervention will be compared within study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Change in Patient Satisfaction Scores (CACHE)
Change in Patient Satisfaction with Health Care in IBD (CACHE) scores between enrollment and post-intervention will be compared within study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Rates of IBD-related hospitalizations
Event rates over trial period will be compared between study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Rates of IBD-related surgery over intervention period
Event rates over trial period will be compared between study groups
Time frame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Started Jan 2018 (actual). Primary completion is estimated for May 2019, 16 months after the start.
Of 282 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 16 months is below that.
Counting every sponsor, half of 296 studies reached it within 27 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada →