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Anxiety is common among primary care patients, but is undertreated. The purpose of this study is to evaluate whether a brief anxiety treatment designed for VA primary care is more effective at reducing anxiety symptoms in Veterans compared to usual care. The investigators will also examine whether Veterans like the brief treatment and whether the treatment can be feasibly delivered in primary care. Forty-eight adult Veteran primary care patients from the Syracuse VAMC who are experiencing anxiety symptoms will be recruited and randomly assigned to receive the brief anxiety treatment or usual care. The brief treatment consists of up to six 30-minute sessions with a cognitive-behavioral skills focus. The investigators will compare anxiety symptom severity between the two groups at baseline and at post-assessment 16 weeks later.
Background/Rationale: Many Veteran primary care patients experience impairing symptoms of anxiety, but rates of treatment are low. Primary Care-Mental Health Integration (PC-MHI), in which mental health clinicians provide brief treatment in the primary care setting, can bridge the gap between demand for, and availability of, anxiety treatment. However, brief anxiety interventions suitable for use in the PC-MHI setting are needed. Developing an effective brief PC-MHI intervention for anxiety would address a gap in VA treatment options and facilitate high quality healthcare that improves treatment engagement, clinical outcomes, and patient experience. To ensure maximum reach, this intervention should accommodate a variety of subthreshold and diagnostic anxiety presentations, as well as comorbid depression.
Objectives: The overall goal of this research program is to develop, refine, and evaluate a brief anxiety intervention that will be acceptable to Veterans and feasible for PC-MHI providers. The primary aim of the current study is to conduct a pilot randomized controlled trial to evaluate feasibility, acceptability, potential implementation barriers and facilitators, and effectiveness of the intervention compared to usual care.
Methods: This will be a pilot hybrid type I effectiveness-implementation randomized controlled trial (N = 35). The primary goal is to evaluate feasibility, acceptability, and effectiveness of the intervention in reducing anxiety symptom severity compared to usual care. The secondary goal is to collect preliminary data on implementation barriers and facilitators that may affect future real-world uptake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief anxiety intervention | Experimental | Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management |
|
| Usual PC-MHI care | Active Comparator | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief anxiety intervention | Behavioral | Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder-7 at Post-Assessment | The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders. | Baseline & Post-Assessment (at 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 at Post-Assessment | The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life. |
Inclusion Criteria:
Exclusion Criteria:
Inability to communicate in English (as assessed by study staff)
Report or demonstrate hearing impairment that would preclude telephone screening (as assessed by study staff)
Inability to demonstrate informed consent
Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness (SMI) in Problem List
Have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2 years OR screen positive for PTSD (3 or more on PC-PTSD-5)
Currently in psychotherapy/counseling for anxiety and/or depression, defined as any of the following within the past 30 days:
Report severe depressive symptoms (20 or more on Patient Health Questionnaire-9)
At imminent risk of suicide
Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days
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| Name | Affiliation | Role |
|---|---|---|
| Robyn L. Shepardson, PhD | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210-2716 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38810782 | Derived | Shepardson RL, Weisberg RB, Wade M, Maisto SA, Funderburk JS. Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential. J Affect Disord. 2024 Sep 15;361:497-507. doi: 10.1016/j.jad.2024.05.107. Epub 2024 May 27. |
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A telephone eligibility screening identified those eligible to participate in the study, based on study eligibility criteria including endorsing current anxiety anxiety symptoms and not already being in psychotherapy for anxiety/depression.
Participants were adult (age 18 years or older) Veterans recruited from primary care clinics at the Syracuse VA Medical Center from April 2019 through October 2020. Eligible participants were identified through case finding from electronic medical records, direct referrals from primary care and behavioral health providers, or referrals from other local behavioral health research studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Anxiety Intervention | Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills |
| FG001 | Usual PC-MHI Care | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who completed the Baseline assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Anxiety Intervention | Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Generalized Anxiety Disorder-7 at Post-Assessment | The primary outcome of anxiety symptom severity will be measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21 indicating severity of anxiety symptoms; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders. | Enrolled participants who completed Post-Assessment at 16 weeks | Posted | Mean | Standard Deviation | score on a scale | Baseline & Post-Assessment (at 16 weeks) |
|
Adverse event data were collected over the course of a participant's study participation, 16 weeks.
n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
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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 | Brief Anxiety Intervention | Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Participant was admitted to the hospital overnight for monitoring of a pre-existing medical condition that was unrelated to the treatment received in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptom exacerbation | Social circumstances | Systematic Assessment | Clinically significant increase in anxiety and depression symptom severity from 2nd to 3rd intervention session. This was unrelated to the intervention or study, rather it was directly related to a psychosocial stressor (father unexpectedly died). |
This was a single-site pilot trial with a small sample size so results should be interpreted with caution. The attrition rate for assessments was slightly higher in the intervention (vs. comparison) condition. However, multi-level modeling analyses made use of all participant data provided. We did not have a follow-up assessment to examine whether treatment gains were maintained over time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robyn L. Shepardson | VA Center for Integrated Healthcare | 315-425-4400 | 53956 | Robyn.Shepardson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2020 | Mar 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Randomized clinical trial with randomization to the intervention condition or control condition
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Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
| Usual PC-MHI care | Behavioral | Anxiety treatment with mental health provider in local primary care clinic |
|
| Baseline & Post-Assessment (at 16 weeks) |
| Depression Anxiety Stress Scale-21 Anxiety Subscale Change | The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid. | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
| Depression Anxiety Stress Scale-21 Depression Subscale Change | The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid. | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
| Depression Anxiety Stress Scale-21 Stress Subscale Change | The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid. | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
| Overall Anxiety Severity and Impairment Scale Change | Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety. | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
| Overall Depression Severity and Impairment Scale Change | Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression. | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
| Baseline & Post-Assessment (at 16 weeks) |
| Engagement in Treatment | This feasibility outcome measure is the number who attended one or more treatment sessions | Post-assessment (16 weeks) |
| Number of Treatment Sessions Completed | This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase | Post-assessment (16 weeks) |
| Treatment Satisfaction | The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment. | Post-assessment (at 16 weeks) |
| Treatment Credibility | The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility. | Post-assessment (16 weeks) |
| Therapeutic Alliance | The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity. | Post-assessment (16 weeks) |
| BG001 | Usual PC-MHI Care | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Generalized Anxiety Disorder-7 | Anxiety symptom severity was measured by the Generalized Anxiety Disorder-7 (GAD-7) self-report questionnaire. Participants rate how much they have been bothered by each of 7 anxiety symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score ranging from 0 to 21; higher scores indicate more severe symptoms. The total score is sensitive to change from treatment across the anxiety disorders. The GAD-7 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders. | Mean | Standard Deviation | scores on a scale |
|
| Patient Health Questionnaire-9 | Depressive symptom severity was measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity. | Mean | Standard Deviation | scores on a scale |
|
Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills |
| OG001 | Usual PC-MHI Care | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic |
|
|
|
| Secondary | Patient Health Questionnaire-9 at Post-Assessment | The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score from 0 to 27 indicating severity of depressive symptoms; higher scores indicate greater severity. The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity. | Enrolled Participants who completed Post-Assessment at 16 weeks | Posted | Mean | Standard Deviation | score on a scale | Baseline & Post-Assessment (at 16 weeks) |
|
|
|
|
| Secondary | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid. | Enrolled participants who completed each assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
|
|
|
|
| Secondary | Depression Anxiety Stress Scale-21 Depression Subscale Change | The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid. | Enrolled participants who completed each assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
|
|
|
|
| Secondary | Depression Anxiety Stress Scale-21 Stress Subscale Change | The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid. | Enrolled participants who completed each assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
|
|
|
|
| Secondary | Overall Anxiety Severity and Impairment Scale Change | Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety. | Enrolled participants who completed each assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
|
|
|
|
| Secondary | Overall Depression Severity and Impairment Scale Change | Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression. | Enrolled participants who completed each assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) |
|
|
|
|
| Other Pre-specified | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life. | Enrolled Participants who completed Post-Assessment at 16 weeks | Posted | Mean | Standard Deviation | score on a scale | Baseline & Post-Assessment (at 16 weeks) |
|
|
|
|
| Other Pre-specified | Engagement in Treatment | This feasibility outcome measure is the number who attended one or more treatment sessions | All participants who enrolled in the study | Posted | Number | participants | Post-assessment (16 weeks) |
|
|
|
|
| Other Pre-specified | Number of Treatment Sessions Completed | This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase | All participants enrolled in the study | Posted | Mean | Standard Deviation | sessions | Post-assessment (16 weeks) |
|
|
|
|
| Other Pre-specified | Treatment Satisfaction | The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment. | All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session | Posted | Mean | Standard Deviation | score on a scale | Post-assessment (at 16 weeks) |
|
|
|
|
| Other Pre-specified | Treatment Credibility | The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, which asks patients to rate, on a Likert scale from 0 (not at all) to 10 (extremely), how logical this type of anxiety treatment seems, how confident they are that the treatment would eliminate anxiety, how confident they would be in recommending the treatment to a friend with anxiety, and how much improvement they expect to result from it. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility. | All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session | Posted | Mean | Standard Deviation | score on a scale | Post-assessment (16 weeks) |
|
|
|
|
| Other Pre-specified | Therapeutic Alliance | The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, which asks patients to rate, on a Likert scale from 1 (seldom) to 5 (always), their experience of the therapist in terms of quality of the relationship bond, agreement on the goals of treatment, and agreement on the tasks of treatment. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity. | All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session | Posted | Mean | Standard Deviation | score on a scale | Post-assessment (16 weeks) |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Usual PC-MHI Care | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic | 0 | 18 | 1 | 18 | 0 | 18 |
|
|
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| DASS-21 Anxiety subscale total at 4 weeks |
|
|
| DASS-21 Anxiety subscale total at 8 weeks |
|
|
| DASS-21 Anxiety subscale total at 12 weeks |
|
|
| DASS-21 Anxiety subscale total at Post Assessment (16 weeks) |
|
|
Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks |
| Mixed Models Analysis |
| 0.022 |
a priori threshold for statistical significance was p<=0.05 |
| Superiority |
Testing null hypothesis of no difference between groups |
| Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks | Mixed Models Analysis | 0.013 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks) | Mixed Models Analysis | 0.049 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| DASS-21 Depression subscale total at 4 weeks |
|
|
| DASS-21 Depression subscale total at 8 weeks |
|
|
| DASS-21 Depression subscale total at 12 weeks |
|
|
| DASS-21 Depression subscale total at Post-assessment (16 weeks) |
|
|
Change in DASS-21 Depression subscale total from Baseline to 8 weeks |
| Mixed Models Analysis |
| <0.001 |
a priori threshold for statistical significance was p<=0.05 |
| Superiority |
Testing null hypothesis of no difference between groups |
| Change in DASS-21 Depression subscale total from Baseline to 12 weeks | Mixed Models Analysis | <0.001 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks) | Mixed Models Analysis | 0.008 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| DASS-21 Stress subscale total at 4 weeks |
|
|
| DASS-21 Stress subscale total at 8 weeks |
|
|
| DASS-21 Stress subscale total at 12 weeks |
|
|
| DASS-21 Stress subscale total at Post-assessment (16 weeks) |
|
|
Change in DASS-21 Stress subscale total from Baseline to 8 weeks |
| Mixed Models Analysis |
| 0.022 |
a priori threshold for statistical significance was p<=0.05 |
| Superiority |
Testing null hypothesis of no difference between groups |
| Change in DASS-21 Stress subscale total from Baseline to 12 weeks | Mixed Models Analysis | 0.032 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks) | Mixed Models Analysis | 0.091 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| OASIS total at 4 weeks |
|
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| OASIS total at 8 weeks |
|
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| OASIS total at 12 weeks |
|
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| OASIS total at Post-assessment (16 weeks) |
|
|
Change in OASIS total score from Baseline to 8 weeks |
| Mixed Models Analysis |
| 0.032 |
a priori threshold for statistical significance was p<=0.05 |
| Superiority |
Testing null hypothesis of no difference between groups |
| Change in OASIS total score from Baseline to 12 weeks | Mixed Models Analysis | 0.007 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| Change in OASIS total score from Baseline to Post assessment (16 weeks) | Mixed Models Analysis | 0.044 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| ODSIS total at 4 weeks |
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| ODSIS total at 8 weeks |
|
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| ODSIS total at 12 weeks |
|
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| ODSIS total at Post-assessment (16 weeks) |
|
|
Change in ODSIS total from Baseline to 8 weeks |
| Mixed Models Analysis |
| 0.148 |
a priori threshold for statistical significance was p<=0.05 |
| Superiority |
Testing null hypothesis of no difference between groups |
| Change in ODSIS total from Baseline to 12 weeks | Mixed Models Analysis | 0.002 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |
| Change in ODSIS total from Baseline to Post-assessment (16 weeks) | Mixed Models Analysis | 0.069 | a priori threshold for statistical significance was p<=0.05 | Superiority | Testing null hypothesis of no difference between groups |