AnxietyNCT03794089
Reducing Anxiety and Stress in Primary Care Patients
A study testing Brief anxiety intervention and Usual PC-MHI care in people with Anxiety, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Brief anxiety intervention and Usual PC-MHI care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
Official title: Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Brief anxiety intervention, Usual PC-MHI care
- Keywords
- anxiety, primary health care, Veterans
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief anxiety interventionBehavioural
Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
Usual PC-MHI careBehavioural
Anxiety treatment with mental health provider in local primary care clinic
| Study group | Role | What they receive |
|---|---|---|
| Brief anxiety intervention | Experimental | Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management Receives: Behavioral: Brief anxiety intervention |
| Usual PC-MHI care | Active comparator | Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care Receives: Behavioral: Usual PC-MHI care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline & Post-Assessment (at 16 weeks)
Secondary outcomes (6)
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.
Measured: Baseline & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
The secondary outcome of anxiety symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher anxiety symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Depression Subscale Change
The secondary outcome of depression symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher depressive symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Stress Subscale Change
The secondary outcome of stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21) Stress Subscale. Participants indicate how much each of 7 items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Scores are summed and multiplied by 2 to create a total score ranging from 0 to 42; higher scores indicate higher stress symptoms. This measure has good psychometric properties in both clinical and non-clinical samples. The DASS-21 reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia), which are highly comorbid.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Overall Anxiety Severity and Impairment Scale Change
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (Cronbach's alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment from anxiety.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Overall Depression Severity and Impairment Scale Change
Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability (Cronbach's alpha = .92 in community sample of adults) and validity. Participants indicate the frequency and intensity of depressive symptoms, difficulty engaging in activities, and interference with work/school/home activities and social functioning on a Likert scale from 0 to 4. Scores are summed to create a total score ranging from 0 to 20; higher scores indicate greater symptom severity and functional impairment due to depression.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Apr 2019
- Primary completion17 Mar 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with randomization to the intervention condition or control condition
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robyn L. Shepardson, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794089
- Sponsor's protocol ID
- CDX 18-006
- Status last verified
- Jul 2023
- First submitted
- 2 Jan 2019
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shepardson RL, Weisberg RB, Wade M, Maisto SA, Funderburk JS. Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential. J Affect Disord. 2024 Sep 15;361:497-507. doi: 10.1016/j.jad.2024.05.107. Epub 2024 May 27.
PubMed 38810782
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
- ClinicalTrials.gov ID
- NCT03794089
- Acronym / sponsor ID
- CDX 18-006
- Conditions
- Anxiety
- Keywords
- anxiety, primary health care, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with randomization to the intervention condition or control condition
| Arm | Type | Receives |
|---|---|---|
| Brief anxiety intervention | Experimental | Behavioral: Brief anxiety interventionModular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management |
| Usual PC-MHI care | Active comparator | Behavioral: Usual PC-MHI careAppointment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- Inability to communicate in English (as assessed by study staff)
- Report or demonstrate hearing impairment that would preclude telephone screening (as assessed by study staff)
- Inability to demonstrate informed consent
- Have a diagnosis of obsessive-compulsive disorder (OCD) or serious mental illness (SMI) in Problem List
- Have an encounter diagnosis of post-traumatic stress disorder (PTSD) within the past 2 years OR screen positive for PTSD (3 or more on PC-PTSD-5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief anxiety interventionModular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills | Behavioural | Brief anxiety intervention |
| Usual PC-MHI careAnxiety treatment with mental health provider in local primary care clinic | Behavioural | Usual PC-MHI care |
Primary outcome
Generalized Anxiety Disorder-7 at Post-Assessment
Time frame: 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.
6 secondary outcomes
Patient Health Questionnaire-9 at Post-Assessment
Time frame: Baseline & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Depression Subscale Change
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Depression Anxiety Stress Scale-21 Stress Subscale Change
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Overall Anxiety Severity and Impairment Scale Change
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Overall Depression Severity and Impairment Scale Change
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38810782Shepardson RL, Weisberg RB, Wade M, Maisto SA, Funderburk JS. Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential. J Affect Disord. 2024 Sep 15;361:497-507. doi: 10.1016/j.jad.2024.05.107. Epub 2024 May 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn L. Shepardson, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief anxiety intervention and Usual PC-MHI care in people with Anxiety, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 at Post-Assessment (time frame: Baseline & Post-Assessment (at 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.