Anxiety
Conditions
Keywords
anxiety, primary health care, Veterans
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBrief anxiety intervention
Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
BEHAVIORALUsual PC-MHI care
Anxiety treatment with mental health provider in local primary care clinic
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
Intervention model description
Randomized clinical trial with randomization to the intervention condition or control condition
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Veteran seen in the Syracuse VA Medical Center primary care clinic in the past year * Screen positive for current (past 2 weeks) clinically significant anxiety symptoms (8 on Generalized Anxiety Disorder-7)
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 * defined as not being able to comprehend the study description as assessed by study staff and/or not being able to answer the comprehension of consent questions * have a diagnosis of dementia or severe cognitive impairment (defined by primary care provider or self-report, or having a diagnosis in Problem List) * screen positive for cognitive impairment (3 or more errors on cognitive screener) * Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness (SMI) in Problem List * i.e., psychotic disorders, bipolar disorder * 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: * attending specialty mental health sessions \[excluding a single intake session\] * attending 2 or more Primary Care-Mental Health Integration sessions * Being hospitalized for mental health treatment * Report severe depressive symptoms (20 or more on Patient Health Questionnaire-9) * At imminent risk of suicide * defined as being identified as imminent risk based on study staff's suicide risk assessment \[verified by the PI\] and in need of intensive treatment * e.g., hospitalization\] to ensure safety * Started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 at Post-Assessment | Baseline & Post-Assessment (at 16 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 at Post-Assessment | Baseline & Post-Assessment (at 16 weeks) | 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. |
| Depression Anxiety Stress Scale-21 Anxiety Subscale Change | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) | 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. |
| Depression Anxiety Stress Scale-21 Depression Subscale Change | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) | 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. |
| Depression Anxiety Stress Scale-21 Stress Subscale Change | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) | 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. |
| Overall Anxiety Severity and Impairment Scale Change | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) | 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. |
| Overall Depression Severity and Impairment Scale Change | Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment | Post-assessment (16 weeks) | This feasibility outcome measure is the number who attended one or more treatment sessions |
| Number of Treatment Sessions Completed | Post-assessment (16 weeks) | This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase |
| Treatment Satisfaction | Post-assessment (at 16 weeks) | 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. |
| Treatment Credibility | Post-assessment (16 weeks) | 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. |
| Therapeutic Alliance | Post-assessment (16 weeks) | 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. |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Baseline & Post-Assessment (at 16 weeks) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Brief Anxiety Intervention | Total | Usual PC-MHI Care |
|---|---|---|---|
| Age, Continuous | 49.29 years STANDARD_DEVIATION 15.76 | 47.37 years STANDARD_DEVIATION 16.21 | 45.56 years STANDARD_DEVIATION 16.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Generalized Anxiety Disorder-7 | 12.76 scores on a scale STANDARD_DEVIATION 4.41 | 12.34 scores on a scale STANDARD_DEVIATION 3.72 | 11.94 scores on a scale STANDARD_DEVIATION 3 |
| Patient Health Questionnaire-9 | 11.18 scores on a scale STANDARD_DEVIATION 4.54 | 10.97 scores on a scale STANDARD_DEVIATION 4.76 | 10.78 scores on a scale STANDARD_DEVIATION 5.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 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 | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 27 Participants | 16 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 1 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 1 / 18 |
Outcome results
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.
Time frame: Baseline & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed Post-Assessment at 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Generalized Anxiety Disorder-7 at Post-Assessment | GAD-7 total at Post (16 weeks) | 4.6 score on a scale | Standard Deviation 5.2 |
| Brief Anxiety Intervention | Generalized Anxiety Disorder-7 at Post-Assessment | GAD-7 total at Baseline | 12.5 score on a scale | Standard Deviation 4.2 |
| Usual PC-MHI Care | Generalized Anxiety Disorder-7 at Post-Assessment | GAD-7 total at Baseline | 12.0 score on a scale | Standard Deviation 3.1 |
| Usual PC-MHI Care | Generalized Anxiety Disorder-7 at Post-Assessment | GAD-7 total at Post (16 weeks) | 9.1 score on a scale | Standard Deviation 5.2 |
Comparison: comparisons of groups at post-assessment controls for baseline GAD-7 total scoresp-value: 0.035ANCOVA
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed each assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 8 weeks | 7.0 score on a scale | Standard Deviation 6.3 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 12 weeks | 4.8 score on a scale | Standard Deviation 4.7 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 4 weeks | 10.4 score on a scale | Standard Deviation 7.3 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at Post Assessment (16 weeks) | 4.9 score on a scale | Standard Deviation 5 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at Baseline | 12.4 score on a scale | Standard Deviation 9.4 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at Post Assessment (16 weeks) | 9.6 score on a scale | Standard Deviation 7.7 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at Baseline | 10.1 score on a scale | Standard Deviation 9.5 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 4 weeks | 9.4 score on a scale | Standard Deviation 8.3 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 8 weeks | 10.1 score on a scale | Standard Deviation 8.6 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Anxiety Subscale Change | DASS-21 Anxiety subscale total at 12 weeks | 9.9 score on a scale | Standard Deviation 7.4 |
Comparison: Change in DASS-21 Anxiety subscale total from Baseline to 4 weeksp-value: 0.393Mixed Models Analysis
Comparison: Change in DASS-21 Anxiety subscale total from Baseline to 8 weeksp-value: 0.022Mixed Models Analysis
Comparison: Change in DASS-21 Anxiety subscale total from Baseline to 12 weeksp-value: 0.013Mixed Models Analysis
Comparison: Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)p-value: 0.049Mixed Models Analysis
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed each assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 4 weeks | 8.1 score on a scale | Standard Deviation 5.6 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 12 weeks | 4.5 score on a scale | Standard Deviation 4.3 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 8 weeks | 6.0 score on a scale | Standard Deviation 4.8 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at Post-assessment (16 weeks) | 4.9 score on a scale | Standard Deviation 4.9 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at Baseline | 15.6 score on a scale | Standard Deviation 9.9 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at Post-assessment (16 weeks) | 9.9 score on a scale | Standard Deviation 12.6 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at Baseline | 12.2 score on a scale | Standard Deviation 9.5 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 4 weeks | 11.1 score on a scale | Standard Deviation 11.2 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 8 weeks | 11.9 score on a scale | Standard Deviation 9.6 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Depression Subscale Change | DASS-21 Depression subscale total at 12 weeks | 10.8 score on a scale | Standard Deviation 10.8 |
Comparison: Change in DASS-21 Depression subscale total from Baseline to 4 weeksp-value: 0.008Mixed Models Analysis
Comparison: Change in DASS-21 Depression subscale total from Baseline to 8 weeksp-value: <0.001Mixed Models Analysis
Comparison: Change in DASS-21 Depression subscale total from Baseline to 12 weeksp-value: <0.001Mixed Models Analysis
Comparison: Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)p-value: 0.008Mixed Models Analysis
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed each assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 4 weeks | 16.9 score on a scale | Standard Deviation 8 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 12 weeks | 10.5 score on a scale | Standard Deviation 8 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at Baseline | 18.7 score on a scale | Standard Deviation 8.6 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at Post-assessment (16 weeks) | 7.6 score on a scale | Standard Deviation 9.2 |
| Brief Anxiety Intervention | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 8 weeks | 11.7 score on a scale | Standard Deviation 6.9 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at Post-assessment (16 weeks) | 14.1 score on a scale | Standard Deviation 10.3 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at Baseline | 17.8 score on a scale | Standard Deviation 6.9 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 4 weeks | 17.3 score on a scale | Standard Deviation 11.2 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 8 weeks | 17.0 score on a scale | Standard Deviation 10.4 |
| Usual PC-MHI Care | Depression Anxiety Stress Scale-21 Stress Subscale Change | DASS-21 Stress subscale total at 12 weeks | 16.4 score on a scale | Standard Deviation 11 |
Comparison: Change in DASS-21 Stress subscale total from Baseline to 4 weeksp-value: 0.44Mixed Models Analysis
Comparison: Change in DASS-21 Stress subscale total from Baseline to 8 weeksp-value: 0.022Mixed Models Analysis
Comparison: Change in DASS-21 Stress subscale total from Baseline to 12 weeksp-value: 0.032Mixed Models Analysis
Comparison: Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)p-value: 0.091Mixed Models Analysis
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed each assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Overall Anxiety Severity and Impairment Scale Change | OASIS total at Post-assessment (16 weeks) | 4.1 score on a scale | Standard Deviation 3.8 |
| Brief Anxiety Intervention | Overall Anxiety Severity and Impairment Scale Change | OASIS total at Baseline | 9.4 score on a scale | Standard Deviation 3.9 |
| Brief Anxiety Intervention | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 4 weeks | 6.2 score on a scale | Standard Deviation 3.3 |
| Brief Anxiety Intervention | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 8 weeks | 5.5 score on a scale | Standard Deviation 3.4 |
| Brief Anxiety Intervention | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 12 weeks | 4.8 score on a scale | Standard Deviation 3.7 |
| Usual PC-MHI Care | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 12 weeks | 8.2 score on a scale | Standard Deviation 4 |
| Usual PC-MHI Care | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 8 weeks | 8.0 score on a scale | Standard Deviation 4.6 |
| Usual PC-MHI Care | Overall Anxiety Severity and Impairment Scale Change | OASIS total at Baseline | 9.4 score on a scale | Standard Deviation 2.8 |
| Usual PC-MHI Care | Overall Anxiety Severity and Impairment Scale Change | OASIS total at Post-assessment (16 weeks) | 7.4 score on a scale | Standard Deviation 3.8 |
| Usual PC-MHI Care | Overall Anxiety Severity and Impairment Scale Change | OASIS total at 4 weeks | 8.2 score on a scale | Standard Deviation 3.8 |
Comparison: Change in OASIS total score from Baseline to 4 weeksp-value: 0.058Mixed Models Analysis
Comparison: Change in OASIS total score from Baseline to 8 weeksp-value: 0.032Mixed Models Analysis
Comparison: Change in OASIS total score from Baseline to 12 weeksp-value: 0.007Mixed Models Analysis
Comparison: Change in OASIS total score from Baseline to Post assessment (16 weeks)p-value: 0.044Mixed Models Analysis
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Population: Enrolled participants who completed each assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Overall Depression Severity and Impairment Scale Change | ODSIS total at 4 weeks | 4.3 score on a scale | Standard Deviation 3.7 |
| Brief Anxiety Intervention | Overall Depression Severity and Impairment Scale Change | ODSIS total at 12 weeks | 2.7 score on a scale | Standard Deviation 3.3 |
| Brief Anxiety Intervention | Overall Depression Severity and Impairment Scale Change | ODSIS total at 8 weeks | 3.9 score on a scale | Standard Deviation 3.5 |
| Brief Anxiety Intervention | Overall Depression Severity and Impairment Scale Change | ODSIS total at Post-assessment (16 weeks) | 3.0 score on a scale | Standard Deviation 3.7 |
| Brief Anxiety Intervention | Overall Depression Severity and Impairment Scale Change | ODSIS total at Baseline | 6.5 score on a scale | Standard Deviation 4.3 |
| Usual PC-MHI Care | Overall Depression Severity and Impairment Scale Change | ODSIS total at Post-assessment (16 weeks) | 5.0 score on a scale | Standard Deviation 4.8 |
| Usual PC-MHI Care | Overall Depression Severity and Impairment Scale Change | ODSIS total at Baseline | 6.2 score on a scale | Standard Deviation 4.5 |
| Usual PC-MHI Care | Overall Depression Severity and Impairment Scale Change | ODSIS total at 4 weeks | 5.3 score on a scale | Standard Deviation 4.4 |
| Usual PC-MHI Care | Overall Depression Severity and Impairment Scale Change | ODSIS total at 8 weeks | 5.6 score on a scale | Standard Deviation 5.5 |
| Usual PC-MHI Care | Overall Depression Severity and Impairment Scale Change | ODSIS total at 12 weeks | 6.2 score on a scale | Standard Deviation 5.3 |
Comparison: Change in ODSIS total from Baseline to 4 weeksp-value: 0.328Mixed Models Analysis
Comparison: Change in ODSIS total from Baseline to 8 weeksp-value: 0.148Mixed Models Analysis
Comparison: Change in ODSIS total from Baseline to 12 weeksp-value: 0.002Mixed Models Analysis
Comparison: Change in ODSIS total from Baseline to Post-assessment (16 weeks)p-value: 0.069Mixed Models Analysis
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.
Time frame: Baseline & Post-Assessment (at 16 weeks)
Population: Enrolled Participants who completed Post-Assessment at 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Patient Health Questionnaire-9 at Post-Assessment | PHQ-9 total at Baseline | 10.5 score on a scale | Standard Deviation 5 |
| Brief Anxiety Intervention | Patient Health Questionnaire-9 at Post-Assessment | PHQ-9 total at Post (16 weeks) | 5.1 score on a scale | Standard Deviation 4.7 |
| Usual PC-MHI Care | Patient Health Questionnaire-9 at Post-Assessment | PHQ-9 total at Baseline | 10.8 score on a scale | Standard Deviation 5.2 |
| Usual PC-MHI Care | Patient Health Questionnaire-9 at Post-Assessment | PHQ-9 total at Post (16 weeks) | 7.6 score on a scale | Standard Deviation 6.4 |
Comparison: comparisons of groups at post-assessment controls for baseline PHQ-9 total scoresp-value: 0.231ANCOVA
Other Pre-specified
Engagement in Treatment
This feasibility outcome measure is the number who attended one or more treatment sessions
Time frame: Post-assessment (16 weeks)
Population: All participants who enrolled in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brief Anxiety Intervention | Engagement in Treatment | 15 participants |
| Usual PC-MHI Care | Engagement in Treatment | 13 participants |
Comparison: Testing null hypothesis of no difference between groupsp-value: 0.402Fisher Exact
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
Time frame: Post-assessment (16 weeks)
Population: All participants enrolled in the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Anxiety Intervention | Number of Treatment Sessions Completed | 4.7 sessions | Standard Deviation 2.2 |
| Usual PC-MHI Care | Number of Treatment Sessions Completed | 1.8 sessions | Standard Deviation 1.6 |
Comparison: Testing the null hypothesis of no difference between groupsp-value: <0.001t-test, 2 sided
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.
Time frame: Baseline & Post-Assessment (at 16 weeks)
Population: Enrolled Participants who completed Post-Assessment at 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Anxiety Intervention | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Q-LES-Q-SF total at Baseline | 44.9 score on a scale | Standard Deviation 8.5 |
| Brief Anxiety Intervention | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Q-LES-Q-SF total at Post (16 weeks) | 49.9 score on a scale | Standard Deviation 8.1 |
| Usual PC-MHI Care | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Q-LES-Q-SF total at Post (16 weeks) | 48.7 score on a scale | Standard Deviation 10 |
| Usual PC-MHI Care | Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment | Q-LES-Q-SF total at Baseline | 43.8 score on a scale | Standard Deviation 7.4 |
Comparison: comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scoresp-value: 0.928ANCOVA
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.
Time frame: Post-assessment (16 weeks)
Population: All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Anxiety Intervention | Therapeutic Alliance | 55.00 score on a scale | Standard Deviation 5.54 |
| Usual PC-MHI Care | Therapeutic Alliance | 42.62 score on a scale | Standard Deviation 9.73 |
Comparison: Testing the null hypothesis of no difference between groupsp-value: 0.002t-test, 2 sided
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.
Time frame: Post-assessment (16 weeks)
Population: All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Anxiety Intervention | Treatment Credibility | 34.20 score on a scale | Standard Deviation 5.51 |
| Usual PC-MHI Care | Treatment Credibility | 22.31 score on a scale | Standard Deviation 11.49 |
Comparison: Testing the null hypothesis of no difference between groupsp-value: 0.004t-test, 2 sided
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.
Time frame: Post-assessment (at 16 weeks)
Population: All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Anxiety Intervention | Treatment Satisfaction | 29.80 score on a scale | Standard Deviation 2.82 |
| Usual PC-MHI Care | Treatment Satisfaction | 24.23 score on a scale | Standard Deviation 5.69 |
Comparison: Testing the null hypothesis of no difference between groupsp-value: 0.006t-test, 2 sided