Anxiety DisordersSTARSNCT05398016
Strategies for Treating Anxiety Research Study
A study testing low-intensity intervention for anxiety in people with Anxiety Disorders and Anxiety, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Anxiety
- What is being tested?
- low-intensity intervention for anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: Testing a Task Sharing Model to Expand Access to Mental Health Services for Anxiety
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).
Read the 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.
- Conditions
- Anxiety Disorders, Anxiety
- Being tested
- low-intensity intervention for anxiety
- Keywords
- task sharing, task shifting, lay counselor, psychological treatment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity intervention for anxietyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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"). Receives: Behavioral: low-intensity intervention for anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change in anxiety between pre-treatment and follow-up (12 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change in functioning between pre- and post-treatment (6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start8 Jan 2024
- Primary completion18 Jul 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot trial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenna Renn, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398016
- Sponsor's protocol ID
- UNLV-2022-263
- Acronym
- STARS
- Status last verified
- Mar 2025
- First submitted
- 19 May 2022
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Task Sharing Model to Expand Access to Mental Health Services for Anxiety
- ClinicalTrials.gov ID
- NCT05398016
- Acronym / sponsor ID
- STARS / UNLV-2022-263
- Conditions
- Anxiety Disorders, Anxiety
- Keywords
- task sharing, task shifting, lay counselor, psychological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot trial
| Arm | Type | Receives |
|---|---|---|
| Low-intensity behavioral intervention | Experimental | Behavioral: low-intensity intervention for anxietyBrief behavioral intervention for mild-to-moderate symptoms of anxiety. Delivered via weekly sessions by a trained lay counselor ("coach"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-intensity intervention for anxietyBrief (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). | Behavioural | Low-intensity behavioral intervention |
Primary outcome
Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits.
Time frame: through treatment completion, up to 12 weeks
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.
Change in Anxiety Symptoms
Time frame: change in anxiety between pre- and post-treatment (6-8 weeks)
(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 Avoidance
Time frame: change in avoidance between pre- and post-treatment (6-8 weeks)
(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.
Sustained Change in Anxiety Symptoms
Time frame: change in anxiety between pre-treatment and follow-up (12 weeks)
(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.
4 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: Post-implementation (up to 1 year)
Feasibility of Intervention Measure (FIM)
Time frame: Post-implementation (up to 1 year)
Implementation Appropriateness Measure (IAM)
Time frame: Post-implementation (up to 1 year)
World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: change in functioning between pre- and post-treatment (6-8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenna Renn, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity intervention for anxiety in people with Anxiety Disorders and Anxiety, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits. (time frame: through treatment completion, up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.