An interventional study of low-intensity intervention for anxiety in Anxiety Disorders and Anxiety, sponsored by University of Nevada, Las Vegas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Treatment
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).
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 27 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
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
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: change in anxiety between pre-treatment and follow-up (12 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: Post-implementation (up to 1 year)
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. Each item is scored on a 5-point scale (0 = no difficulty to 4 = extreme difficulty or cannot do). The scores for each item are summed to create a total score. A total score is possible from 0-48, with 48 representing the highest level of disability.
Time frame: change in functioning between pre- and post-treatment (6-8 weeks)
Sustained Change in Avoidance
(Patient outcome) Sustained change in avoidance after treatment (12 weeks follow-up; this is 6 weeks after treatment end) 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.
Time frame: change in avoidance between pre-treatment and follow-up (12 weeks)
| Milestone | Patient Participants | Coach Participants |
|---|---|---|
| Started | 21 | 6 |
| Completed | 17 | 6 |
| Not completed | 4 | 0 |
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.
| scores on scale | Coach Participants |
|---|---|
| Acceptability of Intervention Measure (AIM) | 4.88 (4 to 5) |
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.
| scores on scale | Coach Participants |
|---|---|
| Feasibility of Intervention Measure (FIM) | 5 (5 to 5) |
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.
| scores on a scale | Coach Participants |
|---|---|
| Implementation Appropriateness Measure (IAM) | 4.88 (4 to 5) |
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.
| Participants | Patient Participants |
|---|---|
| Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits. | 17 |
(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.
| scores on scale | Patient Participants |
|---|---|
| Change in Anxiety Symptoms | 4.69 ± 4.44 |
(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.
| scores on scale | Patient Participants |
|---|---|
| Change in Avoidance | 6.68 ± 23.64 |
This 12-item generic health-status measure assesses functioning across six domains: communication, mobility, self-care, interpersonal, life activities, and participation. Each item is scored on a 5-point scale (0 = no difficulty to 4 = extreme difficulty or cannot do). The scores for each item are summed to create a total score. A total score is possible from 0-48, with 48 representing the highest level of disability.
| score on a scale | Patient Participants |
|---|---|
| World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) | 4.600 ± 10.99 |
(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.
| scores on scale | Patient Participants |
|---|---|
| Sustained Change in Anxiety Symptoms | 4.75 ± 4.40 |
(Patient outcome) Sustained change in avoidance after treatment (12 weeks follow-up; this is 6 weeks after treatment end) 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.
| scores on scale | Patient Participants |
|---|---|
| Sustained Change in Avoidance | 11.71 ± 10.93 |
Collected over Active treatment (6-8 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Participants | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Coach Participants | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| Mean | 28.9 (19 to 42) | — | 28.9 (19 to 42) |
| Age, Customized(Participants) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| 18 years of age or older | 21 | 6 | 27 |
| Sex: Female, Male(Participants) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| Female | 18 | 5 | 23 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 19 | 5 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 1 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 3 | 12 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(Participants) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| United States | 21 | 6 | 27 |
| Generalized Anxiety Disorder (GAD-7) scale(units on a scale) | Patient Participants | Coach Participants | Total |
|---|---|---|---|
| Mean | 11.9 ± 2.8 | — | 11.9 ± 2.8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified participant data will be shared with investigators whose proposed data use has been approved through requests to the Principal Investigator. These requests will be considered after publication of the main outcome paper from the project.
Supporting information: Study protocol, Icf
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Nevada, Las Vegas