Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study

NCT06282133 | Recruiting

• 1 other identifier: 2024-1862
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive-behavioural therapy

Outcome Measures

Primary Outcomes (1)

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)

  Structured diagnostic interview

  10 weeks

Secondary Outcomes (4)

• Worry and Anxiety Questionnaire (WAQ)

  10 weeks

• Penn State Worry Questionnaire (PSWQ)

  10 weeks

• Beck Anxiety Inventory (BAI)

  10 weeks

• Beck Depression Inventory-II (BDI-II)

  10 weeks

Other Outcomes (4)

• Intolerance of Uncertainty Scale (IUS)

  10 weeks

• Safety Behaviors Questionnaire (SBQ)

  10 weeks

• Treatment Acceptance and Adherence Scale (TAAS)

  3 weeks

Study Arms (1)

Behavioural Experiments (CBT)

EXPERIMENTAL

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

Interventions

Behavioural Experiments for Intolerance of Uncertainty 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.

Also known as: CBT

Behavioural Experiments (CBT)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

Sponsors & Collaborators

• Universite du Quebec en Outaouais: lead

Study Sites (1)

Universite du Quebec en Outaouais

Gatineau, Quebec, J8X 3X7, Canada

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Michel J. Dugas, Ph.D.

  Universite du Quebec en Outaouais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain C. Lemay, B.A. Psych

CONTACT

819-595-3900; anxiete@uqo.ca

Michel J. Dugas, Ph.D.

CONTACT

819-595-3900; michel.dugas@uqo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Open trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CA (1)