Behavioral Experiments for Generalized Anxiety Disorder

(EC-II-Ado-P Trial)

Overseen By Michel J. Dugas, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Universite du Quebec en Outaouais

Must not be taking: Herbal products

Disqualifiers: Substance use, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 10 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michel J. Dugas, Ph.D.

Principal Investigator

Universite du Quebec en Outaouais

Eligibility Criteria

This trial is for adolescents who have been diagnosed with Generalized Anxiety Disorder (GAD). They should be experiencing excessive worry and anxiety that impacts their daily life. The study aims to help those struggling with the uncertainty that comes with GAD.

Inclusion Criteria

Willingness to maintain stable medication status during participation in the study

Absence of evidence of suicidal intent (based on clinical judgment)

Absence of current participation in other clinical trials (i.e., psychotherapeutic services)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA) targeting intolerance to uncertainty

10 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Evaluations at 4 different times

Treatment Details

Interventions

• Behavioural Experiments for Intolerance of Uncertainty

Trial Overview The pilot study tests a new psychological treatment called Behavioural Experiments for Intolerance of Uncertainty in Adolescents (EC-IIA). It focuses on helping participants manage uncertainty to reduce anxiety, rather than avoiding uncertain situations.

Participant Groups

Group I: Behavioural Experiments (CBT) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Universite du Quebec en Outaouais

Lead Sponsor

Trials

14

Recruited

18,200+