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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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"). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenna Renn, PhD | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada Las Vegas | Las Vegas | Nevada | 89154 | United States |
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.
Upon publication of main outcomes paper; estimated Jan 2026; will remain available indefinitely
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Participants | Low-intensity behavioral intervention: Brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach"). |
| FG001 | Coach Participants | Adults with advanced undergraduate standing or baccalaureate who complete required training and consent to serve as supervised coaches (nonspecialist providers), delivering the brief intervention to patient participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Participants | Adults (18+) with clinically elevated symptoms of anxiety who received brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach"). |
| BG001 | Coach Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was collected and analyzed for patient participants only to characterize the sample. Age was not collected as a continuous variable for coach participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Mean | Full Range | scores on scale | Post-implementation (up to 1 year) |
|
|
Active treatment (6-8 weeks)
Patient participants were non-systematically assessed for adverse events, such as self-reporting in treatment sessions or as follow-up questions if they self-reported such information in routine assessments. Coach participants were non-systematically assessed for serious adverse events in weekly coach supervision meetings, such as self-reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Participants | Adults (18+) with clinically elevated symptoms of anxiety who received brief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach"). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenna Renn, PI | University of Nevada Las Vegas | 7028950569 | brenna.renn@unlv.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2023 | Mar 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2025 | Mar 31, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Single arm pilot trial
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| change in anxiety between pre-treatment and follow-up (12 weeks) |
| 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) |
| 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. | change in functioning between pre- and post-treatment (6-8 weeks) |
| change in avoidance between pre-treatment and follow-up (12 weeks) |
Nonspecialists who were trained and supervised to deliver the experimental intervention with the patient participants. Referred to as "coaches." |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Age, Customized | Proportion of participants aged 18 and older | Count of Participants | Participants |
|
| Sex: Female, Male | Data were collected as gender with multiple options. | Data were collected as gender with multiple options. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Generalized Anxiety Disorder (GAD-7) scale | The 7-item Generalized Anxiety Disorder scale (GAD-7) collects participant-reported anxiety symptom severity and frequency across seven symptoms (e.g., worry, psychosomatic symptoms). Items are score on a 4-point scale, 0=not at all to 3=nearly every day. Total summary scores range from 0-21, with higher scores indicating greater severity (worse) anxiety. This was only collected on patient participants. The GAD-7 was not collected from coach (interventionist) participants. | participant-reported anxiety symptom severity; only collected on patient participants | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | 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. | Posted | Mean | Full Range | scores on scale | Post-implementation (up to 1 year) |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | scores on a scale | Post-implementation (up to 1 year) |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | through treatment completion, up to 12 weeks |
|
|
|
| Primary | 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. | per protocol analysis of completers (n = 17) | Posted | May 2025 | Mean | Standard Deviation | scores on scale | change in anxiety between pre- and post-treatment (6-8 weeks) |
|
|
|
| Primary | 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. | per protocol analysis | Posted | Mean | Standard Deviation | scores on scale | change in avoidance between pre- and post-treatment (6-8 weeks) |
|
|
|
| Secondary | 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. | per protocol analysis | Posted | Mean | Standard Deviation | score on a scale | change in functioning between pre- and post-treatment (6-8 weeks) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on scale | change in anxiety between pre-treatment and follow-up (12 weeks) |
|
|
|
| Other Pre-specified | 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. | per protocol analysis | Posted | Mar 2025 | Mean | Standard Deviation | scores on scale | change in avoidance between pre-treatment and follow-up (12 weeks) |
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Coach Participants | Nonspecialists who were trained and supervised to deliver the experimental intervention with the patient participants. Referred to as "coaches." | 0 | 6 | 0 | 6 | 0 | 6 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|