Reducing Anxiety and Stress in Primary Care Patients

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794089
• Other study ID #: CDX 18-006
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 30, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Brief anxiety intervention
Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
• Usual PC-MHI care
Anxiety treatment with mental health provider in local primary care clinic

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment	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 (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Scores for items 1-14 are summed to create a total score ranging from 14 to 70; higher scores indicate higher quality of life.	Baseline & Post-Assessment (at 16 weeks)
Other	Engagement in Treatment	This feasibility outcome measure is the number who attended one or more treatment sessions	Post-assessment (16 weeks)
Other	Number of Treatment Sessions Completed	This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase	Post-assessment (16 weeks)
Other	Treatment Satisfaction	The acceptability outcome of treatment satisfaction was assessed using the 8-item version of the Client Satisfaction Questionnaire. This self-report questionnaire has evidence of reliability and validity. Participants indicate their agreement with 8 items on a 4-point Likert scale. Scores are summed to create a total score ranging from 8 to 32; higher scores indicate greater satisfaction with treatment.	Post-assessment (at 16 weeks)
Other	Treatment Credibility	The acceptability outcome of treatment credibility was measured using a 4-item adapted version of the Expectancy Rating Scale, 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. Scores are summed to create a total score ranging from 0 to 40; higher scores indicate greater treatment credibility.	Post-assessment (16 weeks)
Other	Therapeutic Alliance	The acceptability outcome of therapeutic alliance was measured using the 12-item Working Alliance Inventory-Short Form Revised, 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. Scores are summed to create a total score ranging from 12 to 60. This measure has good reliability and validity.	Post-assessment (16 weeks)
Primary	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	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.	Baseline & Post-Assessment (at 16 weeks)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)
Secondary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)