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Reducing Anxiety and Stress in Primary Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794089
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Brief anxiety intervention Behavioral: Usual PC-MHI care Not Applicable

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 = 48). The primary goal is to evaluate feasibility, acceptability, and effectiveness of the intervention in reducing anxiety symptom severity compared to usual care. The secondary goal is to collect preliminary data on implementation barriers and facilitators that may affect future real-world uptake.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial with randomization to the intervention condition or control condition
Masking: Single (Outcomes Assessor)
Masking Description: Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
Primary Purpose: Treatment
Official Title: Reducing Anxiety and Stress in Primary Care Patients: Pilot RCT of a Brief Intervention (CDA 15-262)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Brief anxiety intervention
Modular anxiety intervention designed for PC-MHI, up to six 30-minute sessions occurring approximately every 2 weeks, patients select modules of interest to them to complete, emphasis on psycho-education and cognitive-behavioral coping strategies for self-management
Behavioral: Brief anxiety intervention
Modular anxiety intervention, tailored for Veterans, with emphasis on healthy active coping skills

Active Comparator: Usual PC-MHI care
Appointment with PC-MHI provider at local primary care clinic, providers delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PC-MHI care
Behavioral: Usual PC-MHI care
Anxiety treatment with mental health provider in local primary care clinic




Primary Outcome Measures :
  1. Generalized Anxiety Disorder-7 Change [ 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 indicating severity of anxiety symptoms (minimal, mild, moderate, severe). 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 :
  1. Patient Health Questionnaire-9 Change [ Time Frame: Baseline & Post-Assessment (at 16 weeks) ]
    The secondary outcome of depressive symptom severity will be measured by the Patient Health Questionnaire-9 (PHQ-9) self-report questionnaire, a validated measure that is widely used in VA primary care. Participants rate how often they have been bothered by each of 9 symptoms over the last 2 weeks on a Likert scale from 0 (not at all) to 3 (nearly every day). Scores are summed to create a total score indicating severity of depressive symptoms (minimal, mild, moderate, moderately severe, severe). The total score is sensitive to change from treatment. The PHQ-9 has demonstrated reliability and validity.

  2. Depression Anxiety Stress Scale-21 Change [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) ]
    The secondary outcome of depression, anxiety, and stress symptoms will be measured with the Depression Anxiety Stress Scale-21 (DASS-21), 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. This measure reliably distinguishes between symptoms of anxiety (panic/worry), stress (tension/agitation), and depression (low mood/anhedonia) which are highly comorbid. At 4, 8, and 12 weeks this measure will be obtained by telephone.

  3. Overall Anxiety Severity and Impairment Scale Change [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) ]
    Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability ( = .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. At 4, 8, and 12 weeks this measure will be obtained by telephone.

  4. Overall Depression Severity and Impairment Scale Change [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks) ]
    Functional impairment from depressive symptoms will be measured using the Overall Depression Severity and Impairment Scale (ODSIS), which measures symptom severity and functional impairment across depressive disorders and subthreshold symptoms. Adapted from the OASIS to apply to depression, the 5-item scale demonstrates reliability ( = .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. At 4, 8, and 12 weeks this measure will be obtained by telephone.


Other Outcome Measures:
  1. Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form Change [ Time Frame: Baseline & Post-Assessment (at 16 weeks) ]
    Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable ( = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794089


Contacts
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Contact: Robyn L Shepardson, PhD (315) 425-4400 ext 53956 Robyn.Shepardson@va.gov

Locations
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United States, New York
Syracuse VA Medical Center, Syracuse, NY Recruiting
Syracuse, New York, United States, 13210
Contact: Robyn L Shepardson, PhD    315-425-4400 ext 53956    Robyn.Shepardson@va.gov   
Principal Investigator: Robyn L. Shepardson, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Robyn L. Shepardson, PhD Syracuse VA Medical Center, Syracuse, NY
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03794089    
Other Study ID Numbers: CDX 18-006
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators update this after consulting VA HSR&D policies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
anxiety
primary health care
Veterans
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders