NCT03794089

Reducing Anxiety and Stress in Primary Care Patients

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Brief anxiety intervention in Anxiety in 35 participants. Completed in 30 December 2021.

Timeline

1 April 2019

Primary endpoint
17 March 2021

30 December 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	35
Start date	1 April 2019
Primary completion	17 March 2021
Estimated completion	30 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Brief anxiety intervention
• Usual PC-MHI care

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Generalized Anxiety Disorder-7 at Post-Assessment Primary · 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 total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	12.5	± 4.2
Usual PC-MHI Care	12.0	± 3.1

GAD-7 total at Post (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	4.6	± 5.2
Usual PC-MHI Care	9.1	± 5.2

Patient Health Questionnaire-9 at Post-Assessment Secondary · 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 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

PHQ-9 total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	10.5	± 5.0
Usual PC-MHI Care	10.8	± 5.2

PHQ-9 total at Post (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	5.1	± 4.7
Usual PC-MHI Care	7.6	± 6.4

Depression Anxiety Stress Scale-21 Anxiety Subscale Change Secondary · Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

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 (pa

DASS-21 Anxiety subscale total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	12.4	± 9.4
Usual PC-MHI Care	10.1	± 9.5

DASS-21 Anxiety subscale total at 4 weeks

Group	Value	95% CI
Brief Anxiety Intervention	10.4	± 7.3
Usual PC-MHI Care	9.4	± 8.3

DASS-21 Anxiety subscale total at 8 weeks

Group	Value	95% CI
Brief Anxiety Intervention	7.0	± 6.3
Usual PC-MHI Care	10.1	± 8.6

DASS-21 Anxiety subscale total at 12 weeks

Group	Value	95% CI
Brief Anxiety Intervention	4.8	± 4.7
Usual PC-MHI Care	9.9	± 7.4

DASS-21 Anxiety subscale total at Post Assessment (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	4.9	± 5.0
Usual PC-MHI Care	9.6	± 7.7

Depression Anxiety Stress Scale-21 Depression Subscale Change Secondary · Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

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 an

DASS-21 Depression subscale total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	15.6	± 9.9
Usual PC-MHI Care	12.2	± 9.5

DASS-21 Depression subscale total at 4 weeks

Group	Value	95% CI
Brief Anxiety Intervention	8.1	± 5.6
Usual PC-MHI Care	11.1	± 11.2

DASS-21 Depression subscale total at 8 weeks

Group	Value	95% CI
Brief Anxiety Intervention	6.0	± 4.8
Usual PC-MHI Care	11.9	± 9.6

DASS-21 Depression subscale total at 12 weeks

Group	Value	95% CI
Brief Anxiety Intervention	4.5	± 4.3
Usual PC-MHI Care	10.8	± 10.8

DASS-21 Depression subscale total at Post-assessment (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	4.9	± 4.9
Usual PC-MHI Care	9.9	± 12.6

Depression Anxiety Stress Scale-21 Stress Subscale Change Secondary · Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)

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

DASS-21 Stress subscale total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	18.7	± 8.6
Usual PC-MHI Care	17.8	± 6.9

DASS-21 Stress subscale total at 4 weeks

Group	Value	95% CI
Brief Anxiety Intervention	16.9	± 8.0
Usual PC-MHI Care	17.3	± 11.2

DASS-21 Stress subscale total at 8 weeks

Group	Value	95% CI
Brief Anxiety Intervention	11.7	± 6.9
Usual PC-MHI Care	17.0	± 10.4

DASS-21 Stress subscale total at 12 weeks

Group	Value	95% CI
Brief Anxiety Intervention	10.5	± 8.0
Usual PC-MHI Care	16.4	± 11.0

DASS-21 Stress subscale total at Post-assessment (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	7.6	± 9.2
Usual PC-MHI Care	14.1	± 10.3

Overall Anxiety Severity and Impairment Scale Change Secondary · 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 (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; hi

OASIS total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	9.4	± 3.9
Usual PC-MHI Care	9.4	± 2.8

OASIS total at 4 weeks

Group	Value	95% CI
Brief Anxiety Intervention	6.2	± 3.3
Usual PC-MHI Care	8.2	± 3.8

OASIS total at 8 weeks

Group	Value	95% CI
Brief Anxiety Intervention	5.5	± 3.4
Usual PC-MHI Care	8.0	± 4.6

OASIS total at 12 weeks

Group	Value	95% CI
Brief Anxiety Intervention	4.8	± 3.7
Usual PC-MHI Care	8.2	± 4.0

OASIS total at Post-assessment (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	4.1	± 3.8
Usual PC-MHI Care	7.4	± 3.8

Overall Depression Severity and Impairment Scale Change Secondary · 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 (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 sca

ODSIS total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	6.5	± 4.3
Usual PC-MHI Care	6.2	± 4.5

ODSIS total at 4 weeks

Group	Value	95% CI
Brief Anxiety Intervention	4.3	± 3.7
Usual PC-MHI Care	5.3	± 4.4

ODSIS total at 8 weeks

Group	Value	95% CI
Brief Anxiety Intervention	3.9	± 3.5
Usual PC-MHI Care	5.6	± 5.5

ODSIS total at 12 weeks

Group	Value	95% CI
Brief Anxiety Intervention	2.7	± 3.3
Usual PC-MHI Care	6.2	± 5.3

ODSIS total at Post-assessment (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	3.0	± 3.7
Usual PC-MHI Care	5.0	± 4.8

Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment Secondary · 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 (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.

Q-LES-Q-SF total at Baseline

Group	Value	95% CI
Brief Anxiety Intervention	44.9	± 8.5
Usual PC-MHI Care	43.8	± 7.4

Q-LES-Q-SF total at Post (16 weeks)

Group	Value	95% CI
Brief Anxiety Intervention	49.9	± 8.1
Usual PC-MHI Care	48.7	± 10.0

Engagement in Treatment Secondary · Post-assessment (16 weeks)

This feasibility outcome measure is the number who attended one or more treatment sessions

Group	Value	95% CI
Brief Anxiety Intervention	15
Usual PC-MHI Care	13

Number of Treatment Sessions Completed Secondary · Post-assessment (16 weeks)

This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase

Group	Value	95% CI
Brief Anxiety Intervention	4.7	± 2.2
Usual PC-MHI Care	1.8	± 1.6

Treatment Satisfaction Secondary · Post-assessment (at 16 weeks)

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.

Group	Value	95% CI
Brief Anxiety Intervention	29.80	± 2.82
Usual PC-MHI Care	24.23	± 5.69

Treatment Credibility Secondary · Post-assessment (16 weeks)

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.

Group	Value	95% CI
Brief Anxiety Intervention	34.20	± 5.51
Usual PC-MHI Care	22.31	± 11.49

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over the course of a participant's study participation, 16 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brief Anxiety Intervention

Serious: 0/17 (0%)

Deaths: 0/17

Usual PC-MHI Care

Serious: 1/18 (6%)

Deaths: 0/18

Serious adverse events (1 terms)

Reaction	System	Brief Anxiety Intervention	Usual PC-MHI Care
Hospitalization	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Brief Anxiety Intervention	Usual PC-MHI Care
Symptom exacerbation	Social circumstances	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT03794089 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brief modular anxiety intervention for primary care: Hybrid I pilot randomized controlled trial of feasibility, acceptability, effectiveness, and implementation potential.
   Shepardson RL, Weisberg RB, Wade M, Maisto SA, et al · · 2024 · cited 3× · PMID 38810782 · DOI 10.1016/j.jad.2024.05.107