Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study

Generalized Anxiety Disorder Clinical Trial

— EC-II-Ado-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282133
• Other study ID #: 2024-1862
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Universite du Quebec en Outaouais
• Contact: Sylvain C. Lemay, B.A. Psych
• Phone: 819-595-3900
• Email: anxiete[@]uqo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: January 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent - Emotional Problem
• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Universite du Quebec en Outaouais	Gatineau	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Universite du Quebec en Outaouais

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intolerance of Uncertainty Scale (IUS)	Self-report questionnaire	10 weeks
Other	Safety Behaviors Questionnaire (SBQ)	Self-report questionnaire	10 weeks
Other	Treatment Acceptance and Adherence Scale (TAAS)	Self-report questionnaire	3 weeks
Other	Working Alliance Inventory (WAI)	Self-report questionnaire	3 weeks
Primary	Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)	Structured diagnostic interview	10 weeks
Secondary	Worry and Anxiety Questionnaire (WAQ)	Self-report questionnaire	10 weeks
Secondary	Penn State Worry Questionnaire (PSWQ)	Self-report questionnaire	10 weeks
Secondary	Beck Anxiety Inventory (BAI)	Self-report questionnaire	10 weeks
Secondary	Beck Depression Inventory-II (BDI-II)	Self-report questionnaire	10 weeks