Clinical trial NCT05398016: Strategies for Treating Anxiety Research Study
Official title: Testing a Task Sharing Model to Expand Access to Mental Health Services for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Anxiety
Keywords: task sharing
task shifting
lay counselor
psychological treatment
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits.
timeFrame: through treatment completion, up to 12 weeks
measure: Change in Anxiety Symptoms
timeFrame: change in anxiety between pre- and post-treatment (6-8 weeks)
measure: Change in Avoidance
timeFrame: change in avoidance between pre- and post-treatment (6-8 weeks)
measure: Sustained Change in Anxiety Symptoms
timeFrame: change in anxiety between pre-treatment and follow-up (12 weeks)
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Post-implementation (up to 1 year)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Post-implementation (up to 1 year)
measure: Implementation Appropriateness Measure (IAM)
timeFrame: Post-implementation (up to 1 year)
measure: World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: change in functioning between pre- and post-treatment (6-8 weeks)
Other outcomes:
measure: Sustained Change in Avoidance
timeFrame: change in avoidance between pre-treatment and follow-up (12 weeks)
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Brenna Renn, PhD
role: PRINCIPAL_INVESTIGATOR
References: