Anxiety, Anxiety Disorders
Conditions
Keywords
task sharing, task shifting, lay counselor, psychological treatment
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).
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.
Interventions
BEHAVIORALlow-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).
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Change in Anxiety Symptoms | 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. |
| Number of Patient Participants Retained in the Intervention (Out of All of Those Enrolled), as Measured by Completion to All Study Treatment Visits. | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) | change in functioning between pre- and post-treatment (6-8 weeks) | 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. |
| Acceptability of Intervention Measure (AIM) | 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. |
| Feasibility of Intervention Measure (FIM) | 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. |
| Implementation Appropriateness Measure (IAM) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sustained Change in Avoidance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 21 |
| Coach Participants Nonspecialists who were trained and supervised to deliver the experimental intervention with the patient participants. Referred to as coaches. | 6 |
| Total | 27 |
Baseline characteristics
| Characteristic | Patient Participants | Total | Coach Participants |
|---|---|---|---|
| Age, Continuous | 28.9 years | 28.9 years | — |
| Age, Customized 18 years of age or older | 21 Participants | 27 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 24 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Generalized Anxiety Disorder (GAD-7) scale | 11.9 units on a scale STANDARD_DEVIATION 2.8 | 11.9 units on a scale STANDARD_DEVIATION 2.8 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 12 Participants | 3 Participants |
| Region of Enrollment United States | 21 Participants | 27 Participants | 6 Participants |
| Sex: Female, Male Female | 18 Participants | 23 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 6 |
| other Total, other adverse events | 0 / 21 | 0 / 6 |
| serious Total, serious adverse events | 0 / 21 | 0 / 6 |
Outcome results
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.
Time frame: change in anxiety between pre- and post-treatment (6-8 weeks)
Population: per protocol analysis of completers (n = 17)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coach Participants | Change in Anxiety Symptoms | 4.69 scores on scale | Standard Deviation 4.44 |
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.
Time frame: change in avoidance between pre- and post-treatment (6-8 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coach Participants | Change in Avoidance | 6.68 scores on scale | Standard Deviation 23.64 |
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.
Time frame: through treatment completion, up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coach 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 Participants |
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.
Time frame: change in anxiety between pre-treatment and follow-up (12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coach Participants | Sustained Change in Anxiety Symptoms | 4.75 scores on scale | Standard Deviation 4.4 |
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.
Time frame: Post-implementation (up to 1 year)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Coach Participants | Acceptability of Intervention Measure (AIM) | 4.88 scores on 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.
Time frame: Post-implementation (up to 1 year)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Coach Participants | Feasibility of Intervention Measure (FIM) | 5 scores on scale |
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.
Time frame: Post-implementation (up to 1 year)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Coach Participants | Implementation Appropriateness Measure (IAM) | 4.88 scores on a scale |
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.
Time frame: change in functioning between pre- and post-treatment (6-8 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coach Participants | World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) | 4.600 score on a scale | Standard Deviation 10.99 |
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.
Time frame: change in avoidance between pre-treatment and follow-up (12 weeks)
Population: per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coach Participants | Sustained Change in Avoidance | 11.71 scores on scale | Standard Deviation 10.93 |