Task Sharing for Anxiety

Study Overview
=================
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 (n = 5) to patient participants (n = 15).

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 will be five undergraduate students, each working with three patient participants with anxiety (N = 15) 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.

Official Title
-----------------
Testing a Task Sharing Model to Expand Access to Mental Health Services for Anxiety

Conditions
-----------------
Anxiety Disorders, Anxiety

Intervention / Treatment
-----------------
* Behavioral: low-intensity intervention for anxiety


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-intensity behavioral intervention<br>Brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered by a trained lay counselor. | Behavioral: low-intensity intervention for anxiety<br>* Brief (4-6 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention Measure (AIM) | Self-report measure assessing perceived acceptability of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived acceptability. Completed by the trained lay counselors. | Post-implementation (up to 1 year) | 
| Feasibility of Intervention Measure (FIM) | Self-report measure assessing perceived feasibility of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived feasibility. Completed by the trained lay counselors. | Post-implementation (up to 1 year) | 
| Implementation Appropriateness Measure (IAM) | Self-report measure assessing perceived appropriateness of the intervention (an implementation outcome). Scores range from 4-20; higher scores indicate a higher degree of perceived appropriateness. Completed by the trained lay counselors. | Post-implementation (up to 1 year) | 
| Number of patient participants retained in the intervention (out of all of those enrolled), as measured by completion to all study treatment visits. | Retention of patient participants will be measured as an implementation outcome. This will entail quantifying the number of patients who complete the entire course of treatment out of all of those enrolled. | through treatment completion, up to 12 weeks | 
| Change in anxiety symptoms | (Patient outcome) Change between pre- and post-treatment will be assessed using the Structured Interview Guide for the Hamilton Anxiety Scale. This is a clinician-rated measure consisting of 14 items, each defined by a series of symptoms, to measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Total summary score ranges from 0 to 56, with higher scores indicating more severe and frequent symptoms of anxiety. A corresponding interview guide will be used to increase the reliability of the Hamilton Anxiety Scale. This measure has demonstrated sensitivity to change in clinical trials. | change in anxiety between pre- and post-treatment (6 weeks) | 
| Change in avoidance | (Patient outcome) Change in avoidance will be measured using the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a 62-item self report assessment of avoidance. Total scores range from 62 to 372; higher scores reflect higher levels of avoidance. This will be used to measure activation of target mechanism of avoidance. | change in avoidance between pre- and post-treatment (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms (using Beck Anxiety Inventory) | Change in anxiety will also be measured using the Beck Anxiety Inventory (BAI). This is 21-question multiple-choice self-report inventory to measure the severity of anxiety of adults. Total scores range from 0 to 63, with higher scores indicating more severe and frequent symptoms of anxiety. | change in anxiety between pre- and post-treatment (6 weeks) | 
| World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) | This 12-item generic health-status measure assesses functioning across six domains: communication, mobility, self-care, interpersonal, life activities, and participation. Item scores (0 = no difficulty to 4 = extreme difficulty or cannot do) are summed, with higher scores representing greater disability. | change in functioning between pre- and post-treatment (6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
task shifting, task sharing, lay counselor, psychological treatment