An interventional study of Behavioural experiments for intolerance of uncertainty (BE-IU) in Generalized Anxiety Disorder, sponsored by Universite du Quebec en Outaouais. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Universite du Quebec en Outaouais · Not applicable, Interventional, and Treatment
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Among 50 studies in Generalized Anxiety Disorder with a site in Canada — 7 open to participants now, 11 under way, none of them phase 3. Generalized Anxiety Disorder · Canada.
Among the 50 studies in Generalized Anxiety Disorder with a site in Canada, this one is the 29th largest by enrollment of the 45 interventional ones that give a count, is one of 4 that started in 2018, is one of 32 with no phase, and was the 22nd registered.
518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.
Browse Generalized Anxiety Disorder studies →7 of the 50 studies in Generalized Anxiety Disorder with a site in Canada are open now. Recruiting first, the newest first:
Claudio N Soares · Sites in Canada
Ages 18–60
Fraser Health · Sites in Canada
Ages 19+
Queen's University · Sites in Canada
Ages 18–65
Universite du Quebec en Outaouais · Sites in Canada
Ages 14–18 · Healthy volunteers
Dr. Rafael Freire · Sites in Canada
Ages 18–65
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 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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50 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 83 across 440 interventional studies indexed under Generalized Anxiety Disorder.
Median enrollment 63 across the 45 interventional studies, 380 across the 5 observational. Of the 34 that completed or were terminated, 3 (9%) have results posted.
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6 of 50 have an industry lead sponsor. The 10 most frequent:
Universite du Quebec en Outaouais is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Universite du Quebec en Outaouais has 3 studies filed under Generalized Anxiety Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Generalized Anxiety Disorder with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06856161Fraser HealthA Novel Blood Test as a Biomarker in Mental Health | 2027-03-15 |
| NCT05574140McGill University Health Centre/Research Institute of the McGill University Health CentreBreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders | 2027-05-01 |
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Among the 50 studies in Generalized Anxiety Disorder with a site in Canada, from their registry updates:
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Generalized Anxiety Disorder (GAD) is a chronic condition that is characterized by excessive and uncontrollable worry and anxiety. In Canada, 3 to 4% of the population suffer from GAD at any point in time. These individuals have a lowered quality of life and are at risk for many medical conditions such as coronary heart disease and cancer. Research suggests that both pharmacological and psychological approaches are effective for treating GAD in the short-term; however, psychological treatments appear to offer the greatest long-term benefits. There exist a number of effective psychological treatments for GAD, most of which fall into the category of cognitive-behavioural therapy or CBT. In the 1990s, a group of Canadian investigators developed a CBT protocol for GAD that included four components. Data from five clinical trials suggest that one of the four components is particularly important for treatment success: experiencing uncertainty rather than avoiding it in everyday life. Stated differently, learning to tolerate and deal with uncertainty appears to be the key to decreasing worry and anxiety. Given this finding, the investigators have developed a new treatment that exclusively targets intolerance of uncertainty: Behavioural Experiments for Intolerance of Uncertainty or BE-IU. The goal of the current proposal is to test the efficacy of BE-IU (6 weekly treatment sessions) by comparing it to a Waiting List (WL) control condition (6 weeks). A total of 50 participants with a primary diagnosis of GAD will be randomly assigned to either BE-IU or WL and will be assessed at 4 time points ranging from pre-treatment to 12-month follow-up. The conditions will be compared in terms of treatment efficacy and mechanisms. The investigators will also examine the predictors of change during the 12-months following treatment. The proposed study will produce data on the efficacy and mechanisms of a treatment for GAD that is less costly, less complex and easier to disseminate than treatments that are currently available.
Exclusion Criteria:
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Behavioural experiments involve selecting a specific thought to be tested (e.g., "uncertainty makes me unable to act") and designing a detailed experiment to test out the thought.
Behavioral: Behavioural experiments for intolerance of uncertainty (BE-IU)
6 week wait (with assessments) before being transferred to the experimental condition.
CBT
Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)
Structured diagnostic interview
Time frame: 8 weeks
Penn State Worry Questionnaire
16-item self-report questionnaire measuring trait worry. Only the total score is reported (range: 16 to 80). Higher values represent a worse outcome.
Time frame: 8 weeks
Worry and Anxiety Questionnaire
11-item self-report questionnaire measuring diagnostic criteria for generalized anxiety disorder. Only the total score is reported (range: 7 to 35). Higher values represent a worse outcome.
Time frame: 8 weeks
Beck Anxiety Inventory
21-item self-report questionnaire measuring anxiety over the past week. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.
Time frame: 8 weeks
Beck Depression Inventory-II
21-item self-report questionnaire measuring depressive symptoms over the past 2 weeks. Only the total score is reported (range: 0 to 63). Higher values represent a worse outcome.
Time frame: 8 weeks
Intolerance of Uncertainty Scale
27-item self-report questionnaire measuring negative beliefs about uncertainty. Only the total score is reported (range: 27 to 135). Higher values represent a worse outcome.
Time frame: 8 weeks
Safety Behaviours Questionnaire
18-item self-report questionnaire measuring the use of avoidance and safety behaviors. Only the total score is reported (range: 18 to 90). Higher values represent a worse outcome.
Time frame: 8 weeks
Heart rate variability
Heart rate monitoring with chest strap and Polar watch
Time frame: 8 weeks
Acceptance and Action Questionnaire, second edition
10-item self-report questionnaire measuring acceptance of internal experiences and commitment to valued action. Only the total score is reported (range 10 to 70). Higher values represent a better outcome.
Time frame: 8 weeks
Pain Catastrophizing Scale
13-item self-report questionnaire measuring negative beliefs about pain. Only the total score is reported (range: 0 to 52). Higher values represent a worse outcome.
Time frame: 8 weeks
Agression Questionnaire
12-item self-report questionnaire measuring the tendency to become angry. Only the total score is reported (range: 12 to 60). Higher values represent a worse outcome.
Time frame: 8 weeks
Ran from Feb 2018 to primary completion in Jul 2020, 28 months.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 28 months is close to that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Universite du Quebec en Outaouais