Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
Phase: NA
Conditions: Anxiety
Sponsor: VA Office of Research and Development

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Project Title: Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention 
 
IRB Protocol Date:   
3/30/2020 (IRB version 9) 
 
 
ClinicalTrials.gov ID#:  
NCT03794089 
 
Principal Investigator:  
Robyn L. Shepardson, Ph.D. 
Clinical Research Psychologist 
Center for Integrated Healthcare 
Syracuse VA Medical Center 
 
 
 
 
 
 

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Study Protocol with Statistical Analysis Plan 
 
BACKGROUND 
Anxiety disorders and symptoms are common among Veteran primary care patients.1-3 Anxiety has a 
significant impact on the lives of Veteran primary care patients,1-3 including functional impairment,4-5 decreased 
quality of life,6 increased risk for suicidal ideation and attempts,7 and increased health care utilization.1,8 The 
impact of anxiety within the primary care setting is even greater given the high degree of comorbidity with 
depression.9 Approximately 55% of primary care patients with anxiety disorders have current major depressive 
disorder,4,5 and 52% reported depressive symptoms of at least moderate severity, among a sample of 
treatment seeking primary care Veterans with significant anxiety symptoms.  
 
Anxiety is under-treated in primary care.10-12 As few as 15% of VHA patients complete ≥1 session of behavioral 
treatment in the 12 months following a new anxiety diagnosis.13 Reasons for under-treatment of anxiety in 
primary care are varied. PACT providers may be pressed for time, struggle with identification and treatment of 
complex subthreshold symptoms and comorbid presentations, and face competing demands for clinical 
attention that prohibit the use of full-length anxiety-treatment protocols.14 Although a large percentage of 
patients prefer psychological treatments over pharmacotherapy,15-16 pharmacological treatments are the most 
common intervention offered in primary care.  
 
VHA developed the PC-MHI initiative to improve the identification and treatment of mental health problems in 
the primary care setting.18-19 Most patients with anxiety who seek treatment do so in primary care.20,21 VHA PC-
MHI providers are most often psychologists or social workers,22 who have expertise in psychological 
treatments. Offering anxiety treatment within PC-MHI improves the patient-centeredness of care by meeting 
patients where they are at (i.e., in primary care) and accommodating patient preference for psychological 
treatment over pharmacotherapy.15,16 Facilitating patient-centered care for Veterans is one of the primary long-
term goals of PACT23 and VHA as a whole.24 PC-MHI providers can fill a critical need within PACT by providing 
Veterans with patient-centered anxiety treatment. 
 
Established treatments for anxiety disorders have garnered empirical support for delivery in specialty mental 
health settings.25 However, these treatments are not readily translated to PC-MHI. Existing protocols were 
developed for a higher frequency and longer duration of treatment (e.g., 12-15 weekly 50-minute sessions) 
than that used in PC-MHI (e.g., 1-6 biweekly to monthly 30-minute sessions).26,27 Most existing treatments are 
disorder-specific (e.g., CBT for panic disorder28). However, choosing treatments based on specific anxiety 
disorders is not practical in PC-MHI given that primary care patients often exhibit subthreshold anxiety 
symptoms, meet diagnostic criteria for multiple anxiety disorders29, or are given a diagnosis of anxiety not 
otherwise specified.13 Furthermore, PC-MHI providers do not conduct comprehensive diagnostic assessments. 
In addition, 55% of primary care patients with an anxiety disorder also report current major depressive 
disorder.4,5 In sum, a critical need remains for brief, evidence-based interventions that are feasible within the 
PC-MHI format and applicable across the spectrum of anxiety presentations, including comorbid depressive 
symptoms.17,30,78  
 
To address this gap in care, my program of research has comprised several studies building toward the current 
study: identifying Veteran primary care patients’ anxiety treatment preferences, examining usual care for 
anxiety in PC-MHI, examining perceived feasibility of various anxiety intervention techniques among PC-MHI 
providers, and adapting and refining the treatment manual for the brief PC-MHI intervention for anxiety. We 
developed the manual by adapting evidence-based techniques from extant anxiety treatment protocols to fit 
the unique scope and format of the PC-MHI setting. We also incorporated our prior findings on primary care 
Veterans’ anxiety treatment preferences to ensure the intervention is Veteran-centered.76 In the most recent 
study, we obtained preliminary feedback on the treatment manual from Veterans who received the intervention 
as well as PC-MHI providers who were asked to consider feasibility for real-world clinical practice. We used 
this stakeholder feedback to refine the treatment manual. Now we are ready to evaluate the intervention in a 
formal trial. Therefore, in the current study we will evaluate the effectiveness of the intervention (compared to 
PC-MHI usual care) in reducing symptoms of anxiety and depression. Secondary outcomes include functional 
impairment and quality of life as well as several potential mediating variables. We will include healthcare 
utilization (mental health, primary care, emergency department visits) as an exploratory outcome because 
individuals with anxiety disorders are known to have higher healthcare utilization,83 which is costly to the 

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healthcare system.  
 
Specific Aims 
The current study is a pilot hybrid effectiveness-implementation RCT. The primary aim is to evaluate feasibility, 
acceptability, and effectiveness of the brief anxiety intervention compared to PC-MHI usual care. As this is a 
pilot study, the emphasis is on evaluating feasibility and acceptability77, although we will also examine 
preliminary effectiveness by comparing the effects of the intervention to those of PC-MHI usual care on the 
primary outcome of anxiety symptom severity. The secondary aim is to identify potential barriers and 
facilitators to implementation in real-world clinical practice. 
 
METHOD 
Study design  
We will evaluate the intervention through a RCT using a hybrid I effectiveness-implementation design79 with 
PC-MHI usual care as the comparison condition. We elected to conduct an effectiveness trial (with less 
restrictive eligibility criteria), rather than an efficacy trial, because we are not creating a brand-new treatment, 
but rather adapting existing evidence-based techniques into a new intervention package in a format suitable for 
PC-MHI. We selected PC-MHI usual care as the comparison condition given our interest in determining 
whether the intervention is superior to current routine PC-MHI practices. The hybrid I design is appropriate79 
because the brief anxiety intervention has strong face validity and a base of indirect evidence (from brief CBT 
for anxiety used in specialty mental health and PC-MHI), although it still needs to be evaluated for 
effectiveness in its current format. Further, addressing implementation earlier in the process will help to reduce 
the lag in translating research to practice, which is highly valued in VHA. 
 
Participants  
Participants will be adult Veteran primary care patients (N=35) at the Syracuse VA Medical Center. Eligibility 
criteria are as follows: 
 
Inclusion criteria:  
(1) age 18 years or older  
(2) Veteran seen in the Syracuse VAMC primary care clinic in the past year  
(3) screen positive for current (past 2 weeks) clinically significant anxiety symptoms (≥8 on GAD-7) 
 
Exclusion criteria:  
(1) inability to communicate in English (as assessed by study staff)  
(2) report or demonstrate hearing impairment that would preclude telephone screening (as assessed by study 
staff)  
(3) (a) 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),  
OR (b) have a diagnosis of dementia or severe cognitive impairment (defined by primary care provider or 
self-report, or having a diagnosis in Problem List),  
OR (c) screen positive for cognitive impairment (≥3 errors on screener)  
(4) (a) have a diagnosis of obsessive-compulsive disorder (OCD), or serious mental illness (SMI, i.e., psychotic 
disorders, bipolar disorder) in Problem List,  
OR (b) have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2 years OR 
screen positive for PTSD (≥3 on PC-PTSD-5)  
(5) currently in psychotherapy/counseling for anxiety and/or depression (defined as any of the following within 
the past 30 days: (a) attending ≥1 specialty mental health sessions [excluding intake sessions], (b) 
attending ≥2 PC-MHI sessions, or (c) being hospitalized for mental health treatment) 
(6) report severe depressive symptoms (≥20 on PHQ-9)  
(7) 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) 
(8) started or had dosage change in psychotropic medication for anxiety or depression in the past 30 days 
 
Rationale for exclusions: We will exclude Veterans with SMI and/or cognitive impairment given that their 
mental health and/or other treatment needs are likely to be greater than those of Veterans without such 

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conditions, and our focus is on the wider population of primary care patients. We will exclude those with PTSD 
and OCD because (a) our focus is anxiety disorders likely to respond to brief treatment, (b) these disorders are 
no longer considered anxiety disorders in DSM-5,31 (c) they typically require a higher treatment dosage, and 
(d) the intervention will not cover trauma- or OCD-specific education. We will exclude those who were 
hospitalized for mental health reasons in the last 30 days or are currently in psychotherapy/counseling for 
anxiety and/or depression to eliminate confounding treatments. We will not exclude patients on the basis of 
receiving medication management from psychiatric prescribers. We will exclude those with severe depressive 
symptoms due to the focus of this intervention being primarily on anxiety, but we will not exclude those with 
mild, moderate, or moderately severe symptoms (based on PHQ-9) given that the intervention will have at 
least one module on depression and will attend to mood throughout. We will exclude those at imminent risk of 
suicide for safety reasons, but we will not exclude patients based on mild to moderate risk (ongoing risk 
assessment and safety plans will be used as needed). We will allow patients to be on medication for anxiety 
and/or depression, provided it was started or the dosage was stabilized at least 30 days prior.32 We will ask 
those excluded for this reason if they would like to be contacted to be re-screened for eligibility once the 
dosage has been stable for 30 days. 
 
Recruitment 
Recruitment will occur using four methods that we have used in previous work: (1) direct referrals from primary 
care or PC-MHI providers when patients report bothersome anxiety symptoms, (2) flyers in primary care clinic 
waiting rooms that briefly describe the study and invite interested Veterans with anxiety symptoms to contact 
us for more information, (3) referrals from other ongoing local behavioral health research studies, and (4) case-
finding followed by letters (sent with primary care provider approval) describing the study sent to patients with 
anxiety diagnoses in their (a) Problem List or (b) primary care encounter diagnosis who were seen in the last 
month alerting them that research staff may call them in 7-14 days to explain the study (letters will include a 
telephone number to call to opt out of any future contact if the Veteran prefers not to be called). We expect the 
latter method to identify the most participants. We will also use case finding for patients referred from primary 
care to the outpatient mental health clinic for anxiety. There are several other local behavioral health research 
studies, and patients who are ineligible for other studies may be interested in a referral to this study if it seems 
appropriate. For the case finding recruitment method, potential participants will be identified via data pull from 
CPRS. Thus, we are seeking a waiver of HIPAA authorization for recruitment. We will pull data for all living 
Veterans who meet inclusion criteria 1 and 2 and have an anxiety diagnosis in (a) their Problem List or (b) 
recent primary care encounter, but do not meet exclusion criteria 3, 4, 5, or 8.  
 
In addition to VISN2 data pull or study staff chart review of the VA electronic medical record, recruitment lists 
may be obtained through the VA Informatics and Computing Infrastructure (VINCI). Recruitment lists are 
generated through VINCI with an IRB-approved data request to the VA Corporate Data Warehouse, where 
data are prepared and placed into a secure database for use only by approved members of the study team.  
 
Procedure 
Overview: Following an initial telephone screening, eligible Veterans who provide written informed consent to 
participate will complete a baseline assessment. They will be randomized to either the intervention condition or 
the control condition (PC-MHI usual care). Participants will then complete a brief telephone assessment every 
4 weeks and a post-assessment at 16 weeks. 
 
Eligibility screening: Research staff will call Veterans identified via any recruitment method to explain the study 
and screen for eligibility. Eligibility screening will be conducted over the telephone to reduce participant burden. 
(If Veterans specifically request in-person eligibility screening, we will accommodate their preference). We are 
requesting a waiver of documentation of written consent for the eligibility screening only. We will describe the 
study and obtain verbal consent to participate in the eligibility screening, which includes comprehension of 
consent questions to ensure Veterans understand the screening purpose and procedure. (Prior to the baseline 
assessment, we will obtain written informed consent for participation in the remainder of the study). The 
eligibility screening will take approximately 15 minutes. To reduce participant burden, screening will be 
discontinued once any of the exclusion criteria are met. RAs will exclude those who demonstrate inability to 
communicate in English, hearing impairment that would preclude telephone screening, or cognitive impairment 
that would preclude providing informed consent as appropriate during the eligibility screening process. The 
eligibility screening begins with basic demographic questions (age, gender, race, and ethnicity). RAs will then 

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administer a brief screener for cognitive impairment.57 Veterans who make ≥3 errors on the screener are 
ineligible. RAs will screen Veterans for current anxiety symptoms using the GAD-744 self-report questionnaire, 
a validated measure that is widely used in VHA PC-MHI and is a good screening tool for Generalized Anxiety 
Disorder, Panic Disorder, and Social Anxiety Disorder.33 RAs will next administer the PHQ-946 to assess 
current depressive symptoms. Veterans who are ineligible due to scoring ≥20 (severe) on the PHQ-9 will be 
asked if they want a referral to PC-MHI or specialty mental health for depression treatment. For any Veteran 
who reports suicidal ideation on PHQ-9 item 9, RAs will follow the detailed suicide risk assessment protocol as 
appropriate to evaluate and ensure safety (assessments will be reviewed with the PI for clinical supervision). 
RAs will next administer the PC-PTSD-558; Veterans who score ≥3 on PC-PTSD-5 are ineligible and will be 
asked if they want a referral to PC-MHI for further assessment/treatment. RAs will then assess for receipt of 
psychotherapy/counseling for anxiety and/or depression in the last 30 days and mental health hospitalization in 
the past 30 days. RAs will then assess starting, or having a dosage change in, psychotropic medications for 
anxiety or depression in the last 30 days. Veterans who have started a new medication for anxiety or 
depression, or had a dosage change in the past 30 days will be ineligible; however, we will offer to rescreen 
them once the dosage has been stable for 30 days if they would like to be reconsidered. 
 
If the Veteran is ineligible to participate in this study but may be eligible for other local behavioral health 
research studies (e.g., Veteran screens ineligible for this study due to PTSD symptoms and thus may be 
eligible for current PTSD studies), we will ask them if they are interested in hearing about other studies going 
on at the local VA. If they are interested in more information, we will help connect the Veteran participant with 
the research team. 
 
Veterans who are interested and eligible based on the eligibility screening will be scheduled for a baseline 
assessment. At this time, RAs will further describe the study and obtain written informed consent to participate, 
along with a HIPAA Authorization. Participants will then complete the baseline assessment, consisting of a 
demographic questionnaire and self-report measures of anxiety, depression, and other relevant mental health 
constructs (see Measures section below and Table 1 for summary of measures), a medication and mental 
health treatment history interview. The RA assessor will be blinded to condition. This appointment will require 
approximately 75-90 minutes, and participants will be compensated $40 for their time. Participants will be paid 
via either direct deposit (electronic fund transfer) or a Direct Express® prepaid debit card. At the baseline 
session, participants will be given an information sheet with relevant phone numbers for VA behavioral health 
services as well as crisis resources including the Veterans Crisis Line; this is simply for future reference for 
them. Given occasional difficulties contacting participants, if we are unable to reach someone by telephone, we 
will send a letter requesting a return call if still interested in learning about or continuing with the study. 
 
For all participants, treatment initiation and completion (or dropout/withdrawal notes as applicable) notes will be 
entered into CPRS as required. For participants in the intervention condition, progress notes will be entered 
into CPRS for treatment sessions.  
 
Modifications to the baseline process during the COVID-19 outbreak: 
To address public health concerns during the outbreak of covid-19, the baseline assessment will be modified to 
prioritize the health and safety of Veteran patients. The modifications will include the completion of the baseline 
assessment using one of VA’s current telehealth modalities (telephone or VA Video Connect). If using VA 
Video Connect, research staff will work with interested and eligible Veterans to establish the VA Video Connect 
option in preparation for the telehealth appointment. At any VA Video Connect appointments, study staff will 
follow standard VA Video Connect procedures to create a confidential medical virtual room. At the beginning of 
the appointment, we will verify the participant’s current location and phone number to ensure if any disruptions 
occur, we can re-contact the Veteran and provide assistance.  
Before the scheduled baseline assessment, a research assistant will mail two copies each of the 
Informed Consent Form and the HIPAA Authorization form to the participant before the scheduled assessment, 
along with a postage-paid, pre-addressed envelope so they can send the signed informed consent and HIPAA 
authorization forms back to study research staff at the Syracuse VAMC. The packet will also include copies of 
the response options for the questionnaires as well as an information sheet with relevant phone numbers for 
VA behavioral health services and crisis resources including the Veterans Crisis Line. The participant will be 
able to reference these materials during the informed consent process and will be asked to sign both forms 
during the telehealth appointment prior to completing any baseline questionnaires. Participants will be asked to 

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send back the signed informed consent and HIPAA authorization within the self-addressed envelope. No 
intervention sessions or follow-up assessments will occur until this documentation is received. All consent and 
authorization forms will be stored in the same locked file cabinets in the same offices as usual/ previously 
approved. All other assessments will occur via telephone, which is already an option in our standard protocol. 
 
Randomization: Participants will be randomized to the intervention or usual care using a stratified random 
assignment based on anxiety severity (GAD-7 score of <15 vs ≥15 [≥15 indicates severe symptoms]44) as well 
as depression severity (PHQ-9 score of <15 vs 15-19 [15-19 indicates moderately severe symptoms]46). 
Patients with comorbid anxiety and depression symptoms are more functionally impaired than patients with 
either anxiety or depression alone, so it is important to balance out the proportion of patients with worse 
depressive symptoms across the two conditions.  
 
Usual care condition: Usual care will involve the Veteran receiving an appointment with a PC-MHI provider at 
his/her primary care clinic. At this encounter, providers can choose to deliver whatever interventions they deem 
appropriate. In addition, providers and Veterans can collaboratively decide whether and when they would like 
to meet again during the 16-week period of the active portion of the study. These sessions will be audiotaped 
so we can determine what intervention techniques were used in usual care treatment. Independent raters (RAs 
with mental health background and intervention training), will review at least a subset of the usual care session 
recordings and complete a treatment session recording form to identify the interventions used and the overall 
quality of delivery. If the audio recorder should fail during the session, the usual care provider will be asked to 
complete the Content (interventions) portion of the recording form as a self-report measure as soon as 
possible after the session to try to capture the information, whereas the Delivery portion of the form would be 
omitted.  
 
Intervention condition: The intervention will be conducted in up to six 30-minute in-person sessions. The first 
session will occur within two weeks of randomization to minimize potential for changes in health status. 
Sessions will ideally occur approximately biweekly, but to allow flexibility for Veteran scheduling preferences, 
may be scheduled anywhere from weekly to monthly. Because the intervention will be modular and Veteran-
centered, it will be flexible in terms of number of sessions, and this will be determined by the patient and 
therapist, as in real-world PC-MHI clinical practice. (For the purposes of the research study timeline, if all six 
sessions are indicated, they will occur as close to biweekly as possible). Participants will be seen in primary 
care exam rooms to be consistent with routine PC-MHI practice. Requests for telephone sessions will be 
accommodated (if possible based on module content) after the initial session. During the covid-19 outbreak, 
telehealth modalities including telephone and VA Video Connect will be used for both initial and follow-up 
sessions per VA clinical guidance to minimize in-person appointments to reduce unnecessary exposure and 
risk. At the beginning of each session, participants will complete self-report measures of anxiety and 
depression for as part of measurement-based care.80 Participants who endorse >0 on the PHQ-9 item 9 about 
morbid/suicidal ideation item will be assessed further according to our suicide risk assessment protocol. 
Therapists will keep track of which modules were completed and in what order on the post-session checklist.  
 
Therapists: Usual care providers will be local PC-MHI providers. The intervention will be delivered by study 
therapists to reduce the risk of contamination of usual care with the intervention. Study therapists will be 
advanced doctoral students, predoctoral interns, or postdoctoral fellows in psychology or related mental health 
fields who have clinical experience in the PC-MHI setting. Study therapists will be trained by the PI on the 
intervention, including an initial training workshop followed by ongoing weekly/biweekly clinical supervision. All 
intervention sessions will be audio-taped for supervision and training purposes as well as fidelity assessment. 
Independent raters (RAs with mental health background and intervention training), will review the tapes and 
complete a treatment fidelity checklist. (If the audio recorder should fail during an intervention session, the 
study therapist will complete the Fidelity portion of the checklist as a self-report measure as soon as possible 
after the session to try to capture the information, whereas the Delivery portion of the checklist would be 
omitted.) Therapists will receive regular feedback to ensure adherence to essential protocol elements as well 
as competent delivery (e.g., empathy, collaborative spirit). 
 
Follow-up assessments: Participants will complete brief follow-up assessments via telephone approximately 
every 4 weeks between the baseline and post-assessment. An RA who is blinded to condition (and is not the 
interventionist) will administer 3 self-report measures at 4 weeks, 8 weeks, and 12 weeks. Telephone 

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administration was chosen to improve feasibility and reduce burden on participants. (If a Veteran prefers to 
complete these assessments in-person, for example if they are coming in to the VA anyway for another 
appointment, we will accommodate their preference.) These assessments will be brief with only 3 measures 
(total of 31 items) and will allow us to capture symptoms of anxiety, stress, and depression as well as 
functional impairment regularly throughout the study period so we can examine how quickly changes occur 
with treatment. We are interested in the necessary dose to achieve improvement, and these follow-up 
assessments will permit evaluation of whether changes may occur prior to completing the full intervention (e.g., 
after only 1-2 vs. 3-4 vs. maximum dose of 6 sessions). In addition, having more regular contact with research 
staff to complete assessments should help to improve retention in the study over time. These assessments will 
take approximately 10-15 minutes, and participants will be compensated $10 for each one they complete. 
 
Post-assessment: At approximately 16 weeks, participants will return for an in-person post-assessment. An RA 
who is blinded to condition (and was not the interventionist) will administer the self-report measures (see 
Measures section below and Table 1 for summary). (If necessary or per patient preference, the post-
assessment may be conducted via telephone.) After completion of all the aforementioned blinded measures, 
the RA will open a sealed envelope, which will reveal the participant’s condition. The RA will then administer 
the treatment satisfaction, treatment credibility, and therapeutic alliance self-report measures for all participants 
who attended at least one treatment session (regardless of condition), and for those in the intervention 
condition only, the semi-structured acceptability interview. The session will take approximately 90-120 minutes, 
and participants will be compensated $50. Participants will also be provided with a resource information sheet 
and appropriate referrals if interested in obtaining further treatment (e.g., specialty mental health care). 
 
Process evaluation: As part of our hybrid I effectiveness-implementation trial approach, we will conduct a 
mixed methods process evaluation81 of the implementation of the intervention. The goal is to inform future 
implementation rather than evaluate a specific implementation strategy.79 Quantitative data will include 
acceptability including patient satisfaction and credibility, and feasibility including session attendance. We will 
also compare patient perception of therapeutic alliance across conditions. Qualitative data will include patient 
interviews at post-assessment and informal study therapist feedback throughout (e.g., aspects of the 
intervention or modules that may be challenging to deliver in brief sessions). At the end of the study or 
whenever a study therapist is leaving the study team, they will be asked to anonymously complete the Study 
Therapist Debriefing, which includes acceptability, appropriateness, and feasibility84 for the VA PC-MHI setting 
as well as questions implementation barriers and facilitators and training needs.  
 
Intervention Content 
The treatment manual is grounded in evidence-base practice, employs a modular approach, and is applicable 
across a range of anxiety symptom presentations (i.e., type [e.g., generalized anxiety, social anxiety, panic 
symptoms] and severity [subthreshold, mild, moderate]). The treatment type (individual), format (face-to-face, 
for at least the initial session), setting (VHA primary care), and provider (PC-MHI) were selected based on 
Veterans’ clear preferences for this type, format, location, and provider in our prior research.43 To develop the 
treatment manual for this study, we adapted content from extant evidence-based anxiety treatment protocols to 
fit PC-MHI practice. We selected intervention techniques from cognitive-behavioral therapy (CBT) that have 
demonstrated efficacy in treating anxiety,25 including psychoeducation,34 relaxation training,35 cognitive 
restructuring,25 and exposure,25 as well as behavioral activation36 for depression. We also drew on techniques 
from Acceptance and Commitment Therapy (e.g., values, mindfulness) because it has strong empirical support 
for reducing anxiety,37 and evidence-based CBT techniques to address insomnia38 because our pilot data 
indicated Veterans place a high priority on sleep. All of the included intervention techniques have been used 
within modules in prior studies of primary care-based anxiety treatment with good results.32,39,40,41 We adapted 
the scope of existing interventions to fit into the PACT population-based model of care and the brief format 
necessary for PC-MHI.42 The manual emphasizes a psycho-educational approach, focusing on key concepts 
that can be easily taught to a wide audience, and teaching self-management skills26 to empower patients using 
behavioral techniques that can be quickly demonstrated in session and assigned for at-home practice (e.g., 5-
minute deep breathing exercise for relaxation). Consistent with prior research,32,39,40,41 we employed a modular 
approach in the treatment manual to facilitate tailoring the content to individual patients, which will increase 
patient-centeredness. The choice and order of modules used within the intervention will be a collaborative 
decision between the therapist and patient based on patient preference in combination with therapist clinical 
recommendations. The content and format of the intervention were tailored to Veterans’ anxiety treatment 

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preferences43 as much as possible to enhance treatment engagement. We also incorporated findings from our 
prior research with PC-MHI providers regarding feasibility of implementing anxiety intervention techniques in 
real-world practice. Although the intervention focuses primarily on anxiety, it includes a module targeting 
comorbid depressive symptoms, given high comorbidity of major depression among primary care patients with 
anxiety.4,5 This module is optional and will be used as clinically indicated. At the beginning of each session, 
participants will complete self-report measures of anxiety and depression symptoms as part of measurement-
based care.80 (Participants who endorse >0 on the PHQ-9 item 9 will be assessed further according to our 
suicide risk assessment protocol.) 
 
Measures  
See Table 1 for a summary of all measures and time of administration.  
 
Demographics collected during the telephone screen will include: sex, age, race, ethnicity. Additional 
demographic information collected at the baseline assessment will include: marital status, living situation, 
employment status, educational level, household income, distance from VAMC, smart phone status, internet 
access and comfort, non-VA primary care provider, and military service history. 
 
Cognitive impairment will be assessed during eligibility screening using the six-item screener for cognitive 
impairment.57 This measure was adapted from the widely used Mini Mental Status Examination to provide a 
brief screening tool for cognitive impairment for use in clinical research studies. Participants are given three 
objects to recall (apple, table, penny) after repeating them once and then asked three temporal orientation 
items (day of the week, month, year). The scale is unobtrusive and was designed for easy telephone or in-
person administration. A cutoff score of ≥3 errors yields high sensitivity and specificity for cognitive impairment 
and dementia.57 
 
The primary outcome of anxiety symptom severity will be measured by the GAD-744 self-report questionnaire, a 
validated measure that is widely used in VHA PC-MHI, in part due to its applicability across the anxiety 
disorders beyond GAD as well as its brevity. Participants rate how much they have been bothered by each 
problem 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 indicating severity of anxiety symptoms: minimal (0-4), mild (5-9), moderate (10-14), and 
severe (15-21).44 The total score is sensitive to change from treatment across the anxiety disorders.45 The 
GAD-7 (α = .92 in primary care sample) has demonstrated construct and criterion validity and is a good 
screening tool for GAD, SAD, and PD.33  
 
Depressive symptom severity will be measured by the PHQ-9 self-report questionnaire,46 a validated measure 
that is widely used in VHA primary care and PC-MHI as part of mandated annual depression screenings. 
Participants rate how often they have been bothered by each problem over the past two weeks on a Likert 
scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score indicating severity 
of depressive symptoms: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe 
(20-27). A cut-point of 10 is recommended for identifying cases of depression. The total score of the PHQ-9 is 
sensitive to change from treatment.47 The PHQ-9 (α = .86 in primary care samples) demonstrates construct 
and criterion validity.46  
 
Presence of probable PTSD will be assessed during eligibility screening using the Primary Care PTSD Screen 
for DSM-5 (PC-PTSD-5),58 a six-item measure that was designed specifically for use in primary care. The first 
item assesses whether the individual has had any exposure to a Criterion A trauma. If not, the additional 5 
items are not administered. If the individual indicates past trauma exposure, 5 items assess the presence or 
absence (yes/no) of 5 PTSD symptoms in the past month (nightmares/intrusive thoughts, avoidance of 
triggers, hypervigilance, detachment, trauma-specific blame/guilt). The PC-PTSD-5 has good diagnostic 
accuracy and was rated as very easy to understand and complete in primary care. A cutoff score of ≥3 was 
found to be the optimal score for balancing high sensitivity and specificity.58 This measure is very similar to the 
Primary Care PTSD Screen (PC-PTSD) that is currently used for annual PTSD screening of all Veterans 
receiving VA primary care services.59 However, there are 2 key differences.58 First, the PC-PTSD-5 items were 
updated to reflect the latest understanding of PTSD symptoms, resulting in the addition of a fifth item. Second, 
the PC-PTSD-5 begins with an item assessing whether the individual has experienced a true traumatic event. 
In contrast, the PC-PTSD asks about “any experience that was so frightening, horrible, or upsetting,” which can 

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be interpreted widely; as a result, many individuals respond to the items with respect to an upsetting or 
stressful event, such as a divorce, which is stressful but does not meet the clinical definition of a trauma. With 
this change, the PC-PTSD-5 reduces the potential for false positive screens. 
 
Readiness to change will be assessed with a 1-item readiness ruler (adapted61) that asks respondents to 
indicate how ready they are to make a change to improve their anxiety, that is, how ready they are to try out 
new skills learned in treatment for anxiety at home, outside of appointments. The scale ranges from 1 (not 
ready to change) to 10 (already trying to change). Scores of 1-2 suggest being not ready to change, 3-4 
suggest being unsure if ready to change; 5 suggests being at least somewhat ready to change. 
 
Medication and treatment history will be assessed at baseline using a brief interview covering lifetime use of 
mental health treatment. 
 
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and 
Impairment Scale (OASIS),48 which measures symptom severity and functional impairment across anxiety 
disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (α = .84 in primary care 
sample) and validity in primary care patients.49 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 4.48   
 
Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and 
Impairment Scale (ODSIS),51 which measures symptom severity and functional impairment across depressive 
disorders and subthreshold symptoms. Adapted from the OASIS48 to apply to depression, the 5-item scale 
demonstrates reliability (α = .92 in community sample of adults) and validity.51 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.  
 
Stress symptoms, as well as anxiety and depressive symptoms, will be measured with the Depression Anxiety 
Stress Scale-21 (DASS-21),62 which consists of three 7-item subscales: depression, anxiety, and stress. 
Participants indicate how much each of 21 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). This measure has good psychometric 
properties in both clinical and non-clinical samples.63 This measure reliably distinguishes between symptoms of 
anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly 
comorbid. This measure will be administered during the follow-up assessments rather than the GAD-7 and 
PHQ-9 because the GAD-7 and PHQ-9 will be administered at every session to participants in the intervention 
condition as part of measurement-based care and may therefore be subject to assessment reactivity if we also 
administer it during monthly follow-up assessments. 
 
Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form 
(Q-LES-Q-SF),52 which measures overall enjoyment and satisfaction with various aspects of life. The 16-item 
scale is reliable (α=.86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. 
 
Exploratory/tertiary outcomes 
 
Sleep will be measured using the Insomnia Severity Index (ISI),64 which consists of 7 items evaluating 
perceived insomnia (e.g., severity, satisfaction with sleep pattern, interference with daily functioning) over the 
past week. Response options range from 0 (none/not at all) to 4 (very/very much). The ISI has good evidence 
of reliability and validity in clinical and community samples.65 It is responsive to insomnia treatment65 and 
performs well as screening tool for insomnia.64  
 
Pain intensity and interference will be measured using the PEG,66 which is an ultra-brief, 3-item measure. 
Participants indicate their pain intensity, pain interference with enjoyment of life, and pain interference with 
general activity in the past week on a scale from 0 (no pain/does not interfere) to 10 (pain as bad as you can 
imagine/interferes completely). The PEG has good reliability and validity and is sensitive to change.66 This 
measure will be included because chronic pain is extremely prevalent in the VHA primary care population and 
is associated with greater psychological distress,67 and it may impact treatment engagement or effectiveness. 
 

page 10 of 16 
Behavioral activation/engagement will be measured using the Behavioral Activation for Depression Scale-Short 
Form (BADS-SF),70 which consists of 9 items assessing changes in activation. Participants rate how true each 
item was for them over the past week on a scale from 0 (not at all) to 6 (completely). The BADS-SF has good 
reliability and validity. 70  
 
Behavioral avoidance will be measured using the Behavioral Avoidance subscale of the Multidimensional 
Experiential Avoidance Questionnaire (MEAQ),71 which consists of 11 items assessing overt situational 
avoidance of unpleasant emotions. Participants rate how much they agree with each item on a scale from 1 
(strongly disagree) to 6 (strongly agree). 
 
Healthcare utilization will be assessed using self-report items about non-VA appointments (primary care, 
emergency department, and mental health visits) at baseline (6 months prior to baseline) and post-assessment 
(4 months while in study). We will also conduct a chart review in CPRS to obtain objective data (e.g., patient’s 
presenting complaint, diagnoses, GAD-7/PHQ-9 scores, and other indicators of whether appointments were 
related to anxiety symptoms) from progress notes of VA appointments (primary care, emergency department, 
and mental health visits) in the 6 months prior to study enrollment, the 4 months in the study, and the 6 months 
following study completion.  
 
Addition to our assessments in response to the COVID-19 outbreak:  
Given the relevance of the COVID-19 outbreak to the study’s primary outcome of anxiety, we have included a 
few questions related to COVID-19 in the baseline, follow-up, and post assessments so that we can 
understand whether this public health situation had a systematic impact on the study results. The baseline 
questions assess from March 16, 2020 (when the first case was detected in Onondaga County) to the date of 
the baseline, and the post questions assess from the baseline to the date of the post. The single item added to 
the 4, 8, and 12 week assessments references the past week consistent with the other measures given in 
those assessments. Items added to the acceptability interview will help us understand whether delivery by 
telehealth modalities impacted treatment engagement (in either condition). 
 
Treatment related outcomes 
 
Treatment satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ), an 8-item self-report 
questionnaire with evidence of reliability (α = .93) and validity.54 Each item rating and the total CSQ score will 
be used to evaluate participants' satisfaction with the treatment they received. 
 
Treatment credibility will be assessed at post-assessment using a 4-item adapted version55 of the Expectancy 
Rating Scale (ERS),56 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.  
 
Therapeutic alliance will be assessed at post-assessment using the 12-item Working Alliance Inventory-Short 
Form Revised (WAI-SR),85 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. This measure has good reliability and validity.85,86  
 
Acceptability will be assessed by an acceptability interview, which we adapted from our prior work. The semi-
structured interview is designed to assess Veterans’ satisfaction with and perceived helpfulness of specific 
components of the intervention (including handouts), or for those who did not attend any intervention sessions, 
what prevented them from attending and how we could improve the way the treatment is described to appeal 
more to Veterans. It will be used to identify barriers and facilitators to engagement, adherence, and retention to 
guide future implementation efforts.  
 
 
 
 
 

page 11 of 16 
Table 1: Summary of Measures and Time of Administration 
Measure 
Construct 
Telephone 
screening 
Baseline 
Each 
interventi
on 
session 
Follow-up 
assessm
ent 
(telephon
e) 
Post-
assessm
ent 
Demographics 
Demographics 
x 
x 
 
 
 
6-item screener 
Cognitive impairment 
x 
 
 
 
 
GAD-7 
Anxiety symptom severity 
x 
x 
x  
 
x 
PHQ-9 
Depressive symptom severity 
x 
x 
x  
 
x 
PC-PTSD-5 
Probable PTSD (screen) 
x 
 
 
 
 
Treatment history  Counseling/therapy and 
medication use 
x (past 
month) 
x 
(lifetime) 
 
 
 
Readiness ruler 
Readiness to change  
 
x 
 
 
 
OASIS 
Impairment due to anxiety 
 
x 
 
x 
x 
ODSIS 
Impairment due to depression 
 
x 
 
x 
x 
DASS-21 
Stress / Anxiety / Depression  
 
x 
 
x 
x 
Q-LES-Q-SF 
Quality of life 
 
x 
 
 
x 
ISI 
Insomnia 
 
x 
 
 
x 
BADS-SF 
Behavioral activation 
 
x 
 
 
x 
MEAQ-BA 
Behavioral avoidance 
 
x 
 
 
x 
PEG 
Pain intensity/interference 
 
x 
 
 
x 
Healthcare visits 
Healthcare utilization 
 
x 
 
 
x 
COVID-19 
COVID-19 questions 
 
x 
 
x 
x 
CSQ 
Treatment satisfaction 
 
 
 
 
x 
ERS 
Treatment credibility 
 
 
 
 
x 
WAI-SR 
Therapeutic alliance 
 
 
 
 
x 
Interview 
Acceptability of intervention 
 
 
 
 
x 
 
DATA SAFETY, MANAGEMENT, AND SECURITY  
All research staff will be trained by the PI in the responsible conduct of research, including privacy, 
confidentiality, HIPAA and IRB regulations, as well as recruitment procedures, conduct of telephone screening, 
and data entry, management, and analysis. RAs participate in mandated IRB training as well as internal 
training on informed consent. Research staff are trained on maintaining confidentiality and the security of the 
data with supervision by the PI. All study staff are up-to-date with VA Privacy and Information Security and 
Rules of Behavior training. Only current, IRB-approved research staff will have access to the data; if study staff 
leave the research team at any point, their access to data will be terminated. All data will be kept strictly 
confidential and secure per American Psychological Association (APA) ethical standards and IRB 
requirements.  
 
Research staff conducting eligibility screenings and research assessments will alert the PI to any safety 
concerns. All research staff are trained by the PI in data collection regarding mental health topics and suicide 
risk assessment. In addition to the PI, other licensed independent mental health providers will be available as 
back-up on call clinicians to ensure safety in the event of urgent clinical concerns. For patients receiving the 
anxiety intervention, session data (i.e. response to PHQ-9 item 9 suicidal ideation question) will be monitored 
regularly by the PI to ensure patient safety during the treatment. The PI will notify the IRB, in writing, 
immediately, of all serious and unexpected adverse events, regardless of whether or not the event was related 
to the study. The PI supervises periodic internal audits to ensure data integrity and management in accordance 
with VA guidelines and IRB regulations. 
 
Data collection tools such as questionnaires will be labeled with a random identification number, rather than 
the name, so there will be no way to connect a participant to his/her specific responses without the key. The 
key with participant names and linked ID numbers will be stored separately from study data to maintain 
confidentiality and protect participants’ privacy.  
 

page 12 of 16 
Data will be used for research purposes only. All data will be stored securely within the VA. No data will be 
removed from VA premises. Data will be stored in paper (e.g., field notes, questionnaires) and electronic (e.g., 
data from CPRS) form. Paper data will be stored in locked file cabinets located in locked offices in the Center 
for Integrated Healthcare’s main offices. Electronic data will be stored on the VA secure server in password-
protected files. Data obtained through VINCI is stored on secure VA VINCI servers, until it is downloaded by 
the study team to store on the local secure server. To ensure the protection of Veteran data, VINCI maintains 
compliance with the guidelines in VA Handbook 1200.12 and all other applicable VA and VHA policies and 
regulations. Data will not be transmitted outside VA at all. Identifiable data will not be transmitted within VA, 
with the possible exception of being uploaded to VINCI or sent via encrypted VA email to IRB-approved staff 
for data analysis. Excel, SAS, SPSS, and Atlas.ti (licenses owned by the Center for Integrated Healthcare 
and/or accessible through VINCI) may be used for data cleaning and analysis. After data analysis is complete, 
results from group or aggregate data may be reported in research publications; however, no identifiable data 
will be included. Data will be maintained as defined in the VHA Records Control Schedule and destroyed at the 
appropriate time in accordance with these regulations and IRB guidelines. 
 
STATISTICAL ANALYSIS PLAN 
The data will be screened for missing cases, outlier scores, and non-normal response distributions. 
Assumptions underlying statistical models will be assessed by examining standardized residuals, influence 
diagnostics, and homogeneity of variance (e.g. among groups). Descriptive statistics will be calculated for all 
variables. Analyses will be conducted using the intention-to-treat approach; participants who are randomized 
will be analyzed according to their assigned group regardless of amount of treatment received. The a priori 
alpha level for all analyses is 0.05. 
The primary outcome is anxiety symptom severity, measured by GAD-7 scores. The primary analysis 
will be an analysis of covariance (ANCOVA) controlling for baseline GAD-7 score. Secondary analyses will use 
the same approach to evaluate effects on other pre-post outcomes (PHQ-9 and Q-LES-Q-SF). We will adjust 
for baseline scores, thus reducing the residual variance, and theoretically giving us increased power.  
 
Multilevel modeling (MLM) will be used for outcomes with multiple (>2) assessment points (OASIS, 
ODSIS, DASS-21 subscales). MLM will be used to test the primary null hypothesis that no differences exist in 
the rate of change in outcomes between the intervention group and PCMHI usual care group against the two-
sided alternative that differences do exist. A composite equation consisting of within- and between-person 
effects will be used to analyze our data. The within-person (level 1) equation estimates participants' unique 
intercept (time=0) and outcome trajectory. The between-person (level 2) equation estimates the average initial 
status at time 0 and rate of change in the outcome. Random effects include an intercept and slope. Both level-
1 and 2 (subject) residuals are assumed to be normally distributed.  
 
 
 
 
 

page 13 of 16 
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