What is the mechanism of action of this treatment?

The most common treatments for anxiety include Cognitive Behavioral Therapy (CBT) and Selective Serotonin Reuptake Inhibitors (SSRIs). CBT works by helping patients identify and change negative thought patterns and behaviors, thereby reducing anxiety symptoms. SSRIs increase serotonin levels in the brain, which can improve mood and reduce anxiety. Understanding these mechanisms is crucial for anxiety patients as it helps them comprehend how these treatments can alleviate their symptoms, leading to better adherence and more effective management of their condition.

What side effects are associated with this type of intervention?

Behavioral therapies, such as Cognitive Behavioral Therapy (CBT), are commonly used to treat anxiety and are generally well-tolerated with minimal side effects. Some patients may experience temporary increases in anxiety or emotional discomfort as they confront feared situations or thoughts during therapy sessions. Additionally, there may be initial resistance or discomfort with the therapeutic process. However, these side effects are typically short-lived and decrease as therapy progresses.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for anxiety disorders, including selective serotonin reuptake inhibitors (SSRIs) like paroxetine and sertraline, and benzodiazepines such as alprazolam. These medications are often used when rapid symptom relief is needed or when behavioral therapies alone are insufficient. While the FDA has not specifically approved low-intensity behavioral interventions for anxiety, cognitive-behavioral therapy (CBT) is widely recognized and recommended as an effective treatment. The ongoing study of low-intensity behavioral interventions aims to provide a more accessible form of therapy, potentially expanding treatment options for those with mild-to-moderate anxiety disorders.

What other types of research exist?

Promising novel alternatives to Low-Intensity Behavioral Intervention for anxiety patients include: 1) Digital Cognitive Behavioral Therapy (CBT), which leverages online platforms to deliver therapy; 2) Mindfulness-Based Cognitive Therapy (MBCT), which combines mindfulness strategies with cognitive therapy; 3) Virtual Reality Exposure Therapy (VRET), which uses virtual environments to expose patients to anxiety-provoking stimuli in a controlled manner; and 4) Pharmacotherapy advancements, such as new anxiolytic medications or off-label use of existing drugs showing efficacy in recent trials.

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Low-Intensity Behavioral Intervention for Anxiety

N/A

Waitlist Available

Research Sponsored by University of Nevada, Las Vegas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-implementation (up to 1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a simple therapy for people with mild-to-moderate anxiety, especially in underserved areas. The therapy is delivered by trained non-specialists and helps reduce avoidance behaviors.

Who is the study for?

This trial is for adults over 18 with mild-to-moderate anxiety who can attend in-person visits at UNLV, speak English, and have a certain score on the Beck Anxiety Inventory. It's not for those getting psychotherapy, with active suicidal thoughts, severe psychological conditions like psychosis or bipolar disorder, cognitive impairments, substance abuse issues (except depression), or using anti-anxiety meds.

What is being tested?

The study tests a low-intensity behavioral intervention for anxiety delivered by trained lay counselors to see if it's feasible and effective. Fifteen participants will receive this treatment to assess its impact on their anxiety levels.

What are the potential side effects?

Since this is a behavioral intervention rather than medication-based therapy, typical drug side effects are not expected. However, participants may experience discomfort discussing personal experiences related to anxiety during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-implementation (up to 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-implementation (up to 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-implementation (up to 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure (AIM)

Change in anxiety symptoms

Change in avoidance

+3 more

Secondary study objectives

Change in anxiety symptoms (using Beck Anxiety Inventory)

World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)

Other study objectives

Sustained change in anxiety symptoms

Sustained change in avoidance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Low-intensity behavioral interventionExperimental Treatment1 Intervention

Brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered by a trained lay counselor.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for anxiety include Cognitive Behavioral Therapy (CBT) and Selective Serotonin Reuptake Inhibitors (SSRIs). CBT works by helping patients identify and change negative thought patterns and behaviors, thereby reducing anxiety symptoms. SSRIs increase serotonin levels in the brain, which can improve mood and reduce anxiety. Understanding these mechanisms is crucial for anxiety patients as it helps them comprehend how these treatments can alleviate their symptoms, leading to better adherence and more effective management of their condition.

Problem-Focused Psychodynamic Psychotherapies.Psychotherapy for panic disorder.