Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study (EC-II-Ado-P)

Behavioural Experiments for Intolerance of Uncertainty: A Novel Treatment for Generalized Anxiety Disorder in Adolescents - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder; Adolescent - Emotional Problem
• Intervention / Treatment: Behavioral: Behavioural Experiments for Intolerance of Uncertainty

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvain C. Lemay, B.A. Psych; Phone Number: 2501 819-595-3900; Email: anxiete@uqo.ca
• Study Contact Backup: Name: Michel J. Dugas, Ph.D.; Phone Number: 2509 819-595-3900; Email: michel.dugas@uqo.ca

Study Locations

• Canada
  • Quebec
    • Gatineau, Quebec, Canada, J8X 3X7
      • Recruiting
      • Universite du Quebec en Outaouais
      • Contact: Sylvain C Lemay, B.A.; Phone Number: 2501 +1 819-595-3900; Email: sylvainclaude.lemay@uqo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adolescents aged between 14 and 18 years; 2) primary diagnosis of Generalized Anxiety Disorder (GAD); 3) no change in type or dose of medication in the 4 to 12 weeks preceding entry into the study (4 weeks for benzodiazepines, 12 weeks for antidepressants, hypnotics, and psychostimulants); 4) willingness to maintain stable medication status during participation in the study; 5) absence of consumption of herbal products known to have effects on the central nervous system in the 2 weeks preceding entry into the study; 6) absence of evidence of suicidal intent (based on clinical judgment); 7) absence of evidence of current substance use, current or past schizophrenia, bipolar disorder, or organic mental disorder; 8) absence of current participation in other clinical trials (i.e., psychotherapeutic services); 9) absence of concurrent psychotherapy during the trial treatment phase; 10) absence of evidence of anxiety symptoms due to a general medical condition based on clinical judgment (e.g., clinical hyperthyroidism, hypoglycemia, anemia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioural Experiments (CBT); Behavioural experiments involve selecting a specific thought to test (for example, "uncertainty makes me incapable of acting") and designing a detailed experiment to challenge this thought.	Behavioral: Behavioural Experiments for Intolerance of Uncertainty; Behavioural experiments involve selecting a specific thought to test (for example, "uncertainty makes me incapable of acting") and designing a detailed experiment to challenge this thought.; Other Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)	Structured diagnostic interview	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worry and Anxiety Questionnaire (WAQ)	Self-report questionnaire	10 weeks
Penn State Worry Questionnaire (PSWQ)	Self-report questionnaire	10 weeks
Beck Anxiety Inventory (BAI)	Self-report questionnaire	10 weeks
Beck Depression Inventory-II (BDI-II)	Self-report questionnaire	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerance of Uncertainty Scale (IUS)	Self-report questionnaire	10 weeks
Safety Behaviors Questionnaire (SBQ)	Self-report questionnaire	10 weeks
Treatment Acceptance and Adherence Scale (TAAS)	Self-report questionnaire	3 weeks
Working Alliance Inventory (WAI)	Self-report questionnaire	3 weeks

Collaborators and Investigators

• Sponsor: Universite du Quebec en Outaouais
• Investigators: Principal Investigator: Michel J. Dugas, Ph.D., Universite du Quebec en Outaouais

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive-behavioural therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2024-1862

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No