- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398016
Task Sharing for Anxiety
May 25, 2022 updated by: University of Nevada, Las Vegas
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 (n = 5) to patient participants (n = 15).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brenna Renn, PhD
- Phone Number: 702-895-0569
- Email: treatment@unlv.edu
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89154
- University of Nevada Las Vegas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low-intensity behavioral intervention
Brief behavioral intervention for mild-to-moderate symptoms of anxiety.
Delivered by a trained lay counselor.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM)
Time Frame: Post-implementation (up to 1 year)
|
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)
Time Frame: Post-implementation (up to 1 year)
|
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)
Time Frame: Post-implementation (up to 1 year)
|
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.
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.
|
through treatment completion, up to 12 weeks
|
Change in anxiety symptoms
Time Frame: change in anxiety between pre- and post-treatment (6 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 anxiety between pre- and post-treatment (6 weeks)
|
Change in avoidance
Time Frame: change in avoidance between pre- and post-treatment (6 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.
|
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)
Time Frame: change in anxiety between pre- and post-treatment (6 weeks)
|
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)
Time Frame: change in functioning between pre- and post-treatment (6 weeks)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change in anxiety between pre-treatment and follow-up (12 weeks)
|
Sustained change in avoidance
Time Frame: change in avoidance between pre-treatment and follow-up (12 weeks)
|
(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.
|
change in avoidance between pre-treatment and follow-up (12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2023
Primary Completion (ANTICIPATED)
January 1, 2024
Study Completion (ANTICIPATED)
April 1, 2024
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 25, 2022
First Posted (ACTUAL)
May 31, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNLV-2022-263
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Disorders
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
-
Loma Linda UniversityCompletedParental/Caregiver Anxiety | Child's AnxietyUnited States
-
Institut National de la Santé Et de la Recherche...UnknownAnxiety Disorders | Anxiety | Anxiety and FearFrance
Clinical Trials on low-intensity intervention for anxiety
-
Suzhou Municipal HospitalThe First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsNot yet recruiting
-
NYU Langone HealthCompletedGeneralized Anxiety Disorder | Social Anxiety | Panic DisorderUnited States
-
University of TorontoUnknownPostpartum WomenCanada
-
Centre for Addiction and Mental HealthThe Hospital for Sick Children; University of Toronto; Trillium Health Centre; Medical...CompletedPsychosis | Cardiovascular Risk Factor | Metabolic DiseaseCanada
-
Fundación Pública Andaluza Progreso y SaludUnknown
-
Hellenic Anticancer SocietyNational and Kapodistrian University of AthensCompleted
-
The University of Hong KongRecruiting
-
University of UtahDepartment of Health and Human ServicesCompletedObesity | Diabetes | Physical ActivityUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedQuality of Life | Cancer | Fatigue | Anxiety | Sleep Disturbance | Depressive Symptoms | Recurrent DiseaseUnited States
-
VA Office of Research and DevelopmentCompletedStroke | Cerebrovascular AccidentUnited States