protocolSection identificationModule nctId: NCT06282133, orgStudyIdInfo id: 2024-1862, briefTitle: Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study, acronym: EC-II-Ado-P, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universite du Quebec en Outaouais, class: OTHER, descriptionModule briefSummary: Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety.Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments., conditionsModule conditions: Generalized Anxiety Disorder, conditions: Adolescent - Emotional Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural Experiments for Intolerance of Uncertainty, outcomesModule primaryOutcomes measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5), secondaryOutcomes measure: Worry and Anxiety Questionnaire (WAQ), secondaryOutcomes measure: Penn State Worry Questionnaire (PSWQ), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Beck Depression Inventory-II (BDI-II), otherOutcomes measure: Intolerance of Uncertainty Scale (IUS), otherOutcomes measure: Safety Behaviors Questionnaire (SBQ), otherOutcomes measure: Treatment Acceptance and Adherence Scale (TAAS), otherOutcomes measure: Working Alliance Inventory (WAI), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universite du Quebec en Outaouais, status: RECRUITING, city: Gatineau, state: Quebec, zip: J8X 3X7, country: Canada, contacts name: Sylvain C Lemay, B.A., role: CONTACT, phone: +1 819-595-3900, phoneExt: 2501, email: sylvainclaude.lemay@uqo.ca, geoPoint lat: 45.47723, lon: -75.70164, hasResults: False