Strategies for Treating Anxiety Research Study

NCT ID: NCT05398016

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-12-06

Brief Summary

This single-arm pilot clinical trial will evaluate the feasibility, acceptability, and engagement of target mechanism, and preliminary impact of a low-intensity behavioral intervention for mild-to-moderate anxiety disorders. Treatment will delivered by trained lay counselors ("coaches;" n = 5-6) to 2-5 patient participants each depending on enrollment and scheduling (n = up to 25).

Detailed Description

Anxiety is the most common adult mental health condition. Left untreated, it is costly and imparts significant personal and public health burden. Evidence-based psychotherapy (EBP) is an acceptable and effective first-line treatment; however, rural, low-income, and other underserved areas suffer from provider shortages, rendering such treatment largely unavailable. International contexts are beginning to address this problem using provider task sharing, in which low-intensity behavioral health services are delivered by non-specialist health workers (i.e., those with no prior training as a mental health professional). This approach is designed to improve access to care, particularly for those with mild-to-moderate symptoms, and free up limited expert resources. What is lacking is a brief, evidence-based, low-intensity behavioral intervention for mild-to-moderate anxiety disorders as well as an implementation blueprint (e.g., identifying appropriate clinical setting, stakeholder needs, supervision requirements, other counselor and clinic supports) needed to successfully implement and sustain such a novel service model in U.S. contexts. This study will begin to address the above problem in two phases, while creating the foundation for a longterm research program and external funding applications. The primary objective of this work is to develop and preliminarily test a brief intervention for anxiety appropriate for primary care and other non-specialty contexts. Investigators will test the intervention and delivery method via a small, single-arm pilot clinical trial. Non-specialists "coaches" will be trained undergraduate or post-baccalaureate student "coaches" (approx. 5-6 to accommodate patient participant scheduling), each working with three patient participants with anxiety (N = up to 25) to provide preliminary data on fidelity, feasibility, acceptability, preliminary clinical outcomes, and engagement of the target clinical mechanism of avoidance. The activities of these aims will develop community and clinical partnerships for testing and future implementation of low-intensity treatment paradigms.

Conditions

Anxiety Disorders; Anxiety

Study Design

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

Study Groups

Low-intensity behavioral intervention

Brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach").

Group Type: EXPERIMENTAL

low-intensity intervention for anxiety

Intervention Type: BEHAVIORAL

Brief (6-8 weekly 30-min sessions) delivery of a structured behavioral treatment for mild-to-moderate anxiety. Treatment will be based on principles of cognitive behavioral therapy (CBT).

Interventions

low-intensity intervention for anxiety

Brief (6-8 weekly 30-min sessions) delivery of a structured behavioral treatment for mild-to-moderate anxiety. Treatment will be based on principles of cognitive behavioral therapy (CBT).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years,
• score on Beck Anxiety Inventory (BAI) ≥ 16,
• ability to speak English
• willing and able to attend in-person study visits at UNLV
• community dwelling

Exclusion Criteria

• other psychological conditions rendering the person unlikely to benefit from a brief treatment, including psychosis, bipolar disorder, cognitive impairment, and substance abuse or dependence (comorbid depression permitted);
• active suicidal ideation or intent;
• concurrent receipt of regular individual psychotherapy;
• use of anxiolytic medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenna Renn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Las Vegas

Locations

University of Nevada Las Vegas

Las Vegas, Nevada, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UNLV-2022-263

Identifier Type: -

Identifier Source: org_study_id