8 Participants Needed

Behavioral Experiments for Generalized Anxiety Disorder

(EC-II-Ado-P Trial)

SC
MJ
Overseen ByMichel J. Dugas, Ph.D.
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Universite du Quebec en Outaouais
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a new treatment for Generalized Anxiety Disorder (GAD) in teenagers. It aims to assist adolescents who struggle with constant worry by teaching them to handle uncertainty better. The treatment, called Behavioral Experiments for Intolerance of Uncertainty, involves practical exercises that challenge the fear of the unknown. Adolescents with GAD as their primary issue who have not recently changed their medication might be a good fit. The goal is to find a simpler, more effective way to manage GAD in teenagers. As an unphased trial, this study offers teenagers a unique opportunity to explore innovative strategies for managing anxiety.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you need to keep the type and dose the same during the study. If you've recently changed your medication, you might need to wait a bit before joining.

What prior data suggests that this protocol is safe for adolescents?

Research has shown that Cognitive-Behavioral Therapy (CBT) methods, like the one used in this study, are generally easy for people to handle. Specifically, exercises that help individuals manage uncertainty have shown promising results. Studies report significant reductions in symptoms of Generalized Anxiety Disorder (GAD) and related issues after treatment. Many participants continue to feel better for at least six months, suggesting the treatment is safe and effective for many. While side effects can occur, they are usually mild and manageable. Overall, evidence supports the safety of this approach in treating anxiety.12345

Why are researchers excited about this trial?

Researchers are excited about the use of behavioral experiments for treating Generalized Anxiety Disorder (GAD) because this approach offers something different from traditional methods like medication and standard cognitive-behavioral therapy (CBT). Unlike standard treatments, which often focus on symptom management or cognitive restructuring, this technique directly challenges the patient's intolerance of uncertainty by testing specific anxious thoughts through real-world experiments. This hands-on approach can empower patients to confront and reduce their anxiety by providing them with direct evidence that contradicts their fears, potentially leading to more durable and meaningful changes in their anxiety levels.

What evidence suggests that this treatment might be an effective treatment for Generalized Anxiety Disorder?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats generalized anxiety disorder (GAD). Studies have found that about 57% of people recover from GAD within a year after receiving cognitive therapy. This trial will focus on a specific part of CBT, Behavioral Experiments for Intolerance of Uncertainty, which has proven especially effective. This treatment helps participants manage anxiety by directly addressing their fear of uncertainty. By challenging thoughts like "uncertainty makes me unable to act," this method reduces worry and anxiety.16789

Who Is on the Research Team?

MJ

Michel J. Dugas, Ph.D.

Principal Investigator

Universite du Quebec en Outaouais

Are You a Good Fit for This Trial?

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)
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Behavioural Experiments (CBT)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Universite du Quebec en Outaouais

Lead Sponsor

Trials
14
Recruited
18,200+

Citations

CBT treatment delivery formats for generalized anxiety ...Previous network meta-analysis demonstrated that CBT was the most effective type of psychotherapy for patients with GAD [2]. Although ...
A 2–8-year follow-up of two randomized controlled trialsA meta-analysis reports a 57 % recovery rate at 12-month follow-up for cognitive therapy for GAD (Hanrahan et al., 2013), while another study found a 31 % ...
Cognitive-Behavioral Treatments for Anxiety and Stress ...Results (18) have indicated that I-CBT is similarly effective at reducing panic disorder symptoms as face-to-face CBT. The results of ...
Psychotherapies for Generalized Anxiety Disorder in AdultsA recent trial showed that the same CBT protocol is equally effective for generalized anxiety disorder when delivered in person or by ...
The Effectiveness of Cognitive Behavior Therapy on ...However, research has shown that only 50% of patients with generalized anxiety disorder have improved with cognitive-behavioral therapy [28].
Behavioral Experiments for Intolerance of UncertaintyResults indicated substantial decreases in GAD symptoms, general psychopathology, and IU by posttreatment that were generally maintained at 6-month follow-up.
Behavioural Experiments for Generalized Anxiety in ...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 ...
CBT treatment delivery formats for generalized anxiety ...Our findings provide evidence for the consideration of group treatment formats as alternative to individual CBT in relieving anxiety symptoms in patients with ...
Pilot Study | Clinical Research Trial Listing ( AdolescentThe 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 ...
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