- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552108
A Single-Component CBT for GAD
Behavioural Experiments for Intolerance of Uncertainty: A Single-Component Treatment for Generalized Anxiety Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Gatineau, Quebec, Canada, J8X 3X7
- Universite du Quebec en Outaouais
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) at least 18 years of age; 2) principal diagnosis of GAD; 3) no change in medication type or dose in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for antidepressants and hypnotics); 4) willingness to keep medication status stable while participating in the study; 5) no use of herbal products known to have CNS effects in the 2 weeks before study entry; 6) no evidence of suicidal intent (based on clinical judgement); 7) no evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder; 8) no current participation in other trials; 9) no concurrent psychotherapy during treatment phase of trial; 10) no evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycaemia, anaemia).
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioural experiments (CBT)
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.
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Other Names:
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No Intervention: Waiting list
12 week wait (with assessments) before being transferred to the experimental condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician's Severity Rating (CSR) of Anxiety Disorders Interview Schedule (ADIS)
Time Frame: 12 weeks
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Structured diagnostic interview
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penn State Worry Questionnaire (PSWQ)
Time Frame: 12 weeks
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Self-report questionnaire
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12 weeks
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Worry and Anxiety Questionnaire (WAQ)
Time Frame: 12 weeks
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Self-report questionnaire
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12 weeks
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Beck Anxiety Inventory (BAI)
Time Frame: 12 weeks
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Self-report questionnaire
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12 weeks
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Beck Depression Inventory-II (BDI-II)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intolerance of Uncertainty Scale (IUS)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Safety Behaviours Questionnaire (SBQ)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Heart rate variability (HRV)
Time Frame: 14 weeks
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Heart rate monitoring with chest strap and Polar watch
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14 weeks
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Acceptance and Action Questionnaire-2 (AAQ-2)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Pain Catastrophizing Scale (PCS)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 14 weeks
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Self-report questionnaire
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14 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michel J Dugas, Ph.D., Universite du Quebec en Outaouais
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQuebecOutaouais
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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