Reducing Anxiety and Stress in Primary Care Patients

NCT03794089 | Completed Results

• 1 other identifier: CDX 18-006
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

anxiety; primary health care; Veterans

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline & Post-Assessment (at 16 weeks)

Secondary Outcomes (6)

• Patient Health Questionnaire-9 at Post-Assessment

  Baseline & Post-Assessment (at 16 weeks)

• Depression Anxiety Stress Scale-21 Anxiety Subscale Change

  Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

• Depression Anxiety Stress Scale-21 Depression Subscale Change

  Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

• Depression Anxiety Stress Scale-21 Stress Subscale Change

  Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

• Overall Anxiety Severity and Impairment Scale Change

  Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

Other Outcomes (6)

• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment

  Baseline & Post-Assessment (at 16 weeks)

• Engagement in Treatment

  Post-assessment (16 weeks)

• Number of Treatment Sessions Completed

  Post-assessment (16 weeks)

Study Arms (2)

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

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

Behavioral: Usual PC-MHI care

Interventions

Brief anxiety intervention BEHAVIORAL

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

Brief anxiety intervention

Usual PC-MHI care BEHAVIORAL

Anxiety treatment with mental health provider in local primary care clinic

Usual PC-MHI care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

Related Publications (1)

• 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.

  PMID: 38810782 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

This was a single-site pilot trial with a small sample size so results should be interpreted with caution. The attrition rate for assessments was slightly higher in the intervention (vs. comparison) condition. However, multi-level modeling analyses made use of all participant data provided. We did not have a follow-up assessment to examine whether treatment gains were maintained over time.

Results Point of Contact

• Title: Dr. Robyn L. Shepardson
• Organization: VA Center for Integrated Healthcare

Robyn.Shepardson@va.gov

315-425-4400

Study Officials

• Robyn L. Shepardson, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline assessment, monthly follow-up assessments, and post assessment will be conducted by research assistants who are masked to participant condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial with randomization to the intervention condition or control condition

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: April 1, 2019
• Primary Completion: March 17, 2021
• Study Completion: December 30, 2021
• Last Updated: July 27, 2023
• Results First Posted: June 7, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)