Strategies for Treating Anxiety Research Study

NCT05398016 | Completed Results

• 1 other identifier: UNLV-2022-263
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety Disorders; Anxiety

Keywords

task sharing; task shifting; lay counselor; psychological treatment

Outcome Measures

Primary Outcomes (4)

• 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 (6-8 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 (6-8 weeks)

• Sustained Change in Anxiety Symptoms

  (Patient outcome) Change in anxiety between baseline (pre-treatment) and follow-up (12 weeks; 6 week after intervention end) 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-treatment and follow-up (12 weeks)

Secondary Outcomes (4)

• Acceptability of Intervention Measure (AIM)

  Post-implementation (up to 1 year)

• Feasibility of Intervention Measure (FIM)

  Post-implementation (up to 1 year)

• Implementation Appropriateness Measure (IAM)

  Post-implementation (up to 1 year)

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

  change in functioning between pre- and post-treatment (6-8 weeks)

Other Outcomes (1)

• Sustained Change in Avoidance

  change in avoidance between pre-treatment and follow-up (12 weeks)

Study Arms (1)

Low-intensity behavioral intervention

EXPERIMENTAL

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

Behavioral: low-intensity intervention for anxiety

Interventions

low-intensity intervention for anxiety 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).

Low-intensity behavioral intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Brenna Renn, PI
• Organization: University of Nevada Las Vegas

brenna.renn@unlv.edu

7028950569

Study Officials

• Brenna Renn, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pilot trial

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: January 8, 2024
• Primary Completion: July 18, 2024
• Study Completion: December 6, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon publication of main outcomes paper; estimated Jan 2026; will remain available indefinitely
• Access Criteria: Requirements: Scientific rationale: A strong justification for why the data is needed and how it will contribute to scientific advancement. Ethical considerations: A demonstration that the research plan is ethically sound and that potential risks to participants are minimized. Data security and privacy: Measures to ensure the confidentiality and security of the data. Commitment to responsible use: A pledge to use the data ethically and responsibly, in accordance with the study's protocol and relevant regulations.

Locations

US (1)