Back to results

Reducing Anxiety and Stress in Primary Care Patients

Primary Purpose

Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief anxiety intervention

Usual PC-MHI care

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, primary health care, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Syracuse VA Medical Center, Syracuse, NY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief anxiety intervention

Usual PC-MHI care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03794089

First Posted

January 2, 2019

Last Updated

July 19, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03794089

Brief Title

Reducing Anxiety and Stress in Primary Care Patients

Official Title

Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

March 17, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

anxiety, primary health care, Veterans

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial with randomization to the intervention condition or control condition

Masking

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

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brief anxiety intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual PC-MHI care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Brief anxiety intervention

Intervention Description

Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills

Intervention Type

Behavioral

Intervention Name(s)

Usual PC-MHI care

Intervention Description

Anxiety treatment with mental health provider in local primary care clinic

Primary Outcome Measure Information:

Title

Generalized Anxiety Disorder-7 at Post-Assessment

Description

Time Frame

Baseline & Post-Assessment (at 16 weeks)

Secondary Outcome Measure Information:

Title

Patient Health Questionnaire-9 at Post-Assessment

Description

Time Frame

Baseline & Post-Assessment (at 16 weeks)

Title

Depression Anxiety Stress Scale-21 Anxiety Subscale Change

Description

Time Frame