Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study

NCT ID: NCT06282133

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-01-01

Brief 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.

Conditions

Generalized Anxiety Disorder; Adolescent - Emotional Problem

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioural Experiments for Intolerance of Uncertainty

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

Eligibility Criteria

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universite du Quebec en Outaouais

OTHER

Sponsor Role: lead

Responsible Party

Michel Dugas, Ph.D.

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel J. Dugas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universite du Quebec en Outaouais

Locations

Universite du Quebec en Outaouais

Gatineau, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sylvain C. Lemay, B.A. Psych

Role: CONTACT

anxiete@uqo.ca

819-595-3900 ext. 2501

Michel J. Dugas, Ph.D.

Role: CONTACT

michel.dugas@uqo.ca

819-595-3900 ext. 2509

Facility Contacts

Sylvain C Lemay, B.A.

Role: primary

sylvainclaude.lemay@uqo.ca

+1 819-595-3900 ext. 2501

Other Identifiers

2024-1862

Identifier Type: -

Identifier Source: org_study_id