Trial Outcomes & Findings for Reducing Anxiety and Stress in Primary Care Patients (NCT NCT03794089)
NCT ID: NCT03794089
Last Updated: 2023-07-27
Results Overview
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.
COMPLETED
NA
35 participants
Baseline & Post-Assessment (at 16 weeks)
2023-07-27
Participant Flow
Participants were adult (age 18 years or older) Veterans recruited from primary care clinics at the Syracuse VA Medical Center from April 2019 through October 2020. Eligible participants were identified through case finding from electronic medical records, direct referrals from primary care and behavioral health providers, or referrals from other local behavioral health research studies.
A telephone eligibility screening identified those eligible to participate in the study, based on study eligibility criteria including endorsing current anxiety anxiety symptoms and not already being in psychotherapy for anxiety/depression.
Participant milestones
| Measure |
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
Completed 4-week Assessment
|
16
|
18
|
|
Overall Study
Completed 8-week Assessment
|
14
|
18
|
|
Overall Study
Completed 12-week Assessment
|
13
|
17
|
|
Overall Study
COMPLETED
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Reducing Anxiety and Stress in Primary Care Patients
Baseline characteristics by cohort
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.29 years
STANDARD_DEVIATION 15.76 • n=5 Participants
|
45.56 years
STANDARD_DEVIATION 16.88 • n=7 Participants
|
47.37 years
STANDARD_DEVIATION 16.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Generalized Anxiety Disorder-7
|
12.76 scores on a scale
STANDARD_DEVIATION 4.41 • n=5 Participants
|
11.94 scores on a scale
STANDARD_DEVIATION 3.00 • n=7 Participants
|
12.34 scores on a scale
STANDARD_DEVIATION 3.72 • n=5 Participants
|
|
Patient Health Questionnaire-9
|
11.18 scores on a scale
STANDARD_DEVIATION 4.54 • n=5 Participants
|
10.78 scores on a scale
STANDARD_DEVIATION 5.08 • n=7 Participants
|
10.97 scores on a scale
STANDARD_DEVIATION 4.76 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed 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 has demonstrated reliability and validity and is a good screening tool for multiple anxiety disorders.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=11 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=17 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Generalized Anxiety Disorder-7 at Post-Assessment
GAD-7 total at Baseline
|
12.5 score on a scale
Standard Deviation 4.2
|
12.0 score on a scale
Standard Deviation 3.1
|
|
Generalized Anxiety Disorder-7 at Post-Assessment
GAD-7 total at Post (16 weeks)
|
4.6 score on a scale
Standard Deviation 5.2
|
9.1 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline & Post-Assessment (at 16 weeks)Population: Enrolled Participants who completed 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 validity.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=11 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=17 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Patient Health Questionnaire-9 at Post-Assessment
PHQ-9 total at Baseline
|
10.5 score on a scale
Standard Deviation 5.0
|
10.8 score on a scale
Standard Deviation 5.2
|
|
Patient Health Questionnaire-9 at Post-Assessment
PHQ-9 total at Post (16 weeks)
|
5.1 score on a scale
Standard Deviation 4.7
|
7.6 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed each assessment
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
DASS-21 Anxiety subscale total at Baseline
|
12.4 score on a scale
Standard Deviation 9.4
|
10.1 score on a scale
Standard Deviation 9.5
|
|
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
DASS-21 Anxiety subscale total at 4 weeks
|
10.4 score on a scale
Standard Deviation 7.3
|
9.4 score on a scale
Standard Deviation 8.3
|
|
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
DASS-21 Anxiety subscale total at 8 weeks
|
7.0 score on a scale
Standard Deviation 6.3
|
10.1 score on a scale
Standard Deviation 8.6
|
|
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
DASS-21 Anxiety subscale total at 12 weeks
|
4.8 score on a scale
Standard Deviation 4.7
|
9.9 score on a scale
Standard Deviation 7.4
|
|
Depression Anxiety Stress Scale-21 Anxiety Subscale Change
DASS-21 Anxiety subscale total at Post Assessment (16 weeks)
|
4.9 score on a scale
Standard Deviation 5.0
|
9.6 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed each assessment
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Depression Anxiety Stress Scale-21 Depression Subscale Change
DASS-21 Depression subscale total at Baseline
|
15.6 score on a scale
Standard Deviation 9.9
|
12.2 score on a scale
Standard Deviation 9.5
|
|
Depression Anxiety Stress Scale-21 Depression Subscale Change
DASS-21 Depression subscale total at 4 weeks
|
8.1 score on a scale
Standard Deviation 5.6
|
11.1 score on a scale
Standard Deviation 11.2
|
|
Depression Anxiety Stress Scale-21 Depression Subscale Change
DASS-21 Depression subscale total at 8 weeks
|
6.0 score on a scale
Standard Deviation 4.8
|
11.9 score on a scale
Standard Deviation 9.6
|
|
Depression Anxiety Stress Scale-21 Depression Subscale Change
DASS-21 Depression subscale total at 12 weeks
|
4.5 score on a scale
Standard Deviation 4.3
|
10.8 score on a scale
Standard Deviation 10.8
|
|
Depression Anxiety Stress Scale-21 Depression Subscale Change
DASS-21 Depression subscale total at Post-assessment (16 weeks)
|
4.9 score on a scale
Standard Deviation 4.9
|
9.9 score on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed each assessment
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Depression Anxiety Stress Scale-21 Stress Subscale Change
DASS-21 Stress subscale total at 12 weeks
|
10.5 score on a scale
Standard Deviation 8.0
|
16.4 score on a scale
Standard Deviation 11.0
|
|
Depression Anxiety Stress Scale-21 Stress Subscale Change
DASS-21 Stress subscale total at Post-assessment (16 weeks)
|
7.6 score on a scale
Standard Deviation 9.2
|
14.1 score on a scale
Standard Deviation 10.3
|
|
Depression Anxiety Stress Scale-21 Stress Subscale Change
DASS-21 Stress subscale total at Baseline
|
18.7 score on a scale
Standard Deviation 8.6
|
17.8 score on a scale
Standard Deviation 6.9
|
|
Depression Anxiety Stress Scale-21 Stress Subscale Change
DASS-21 Stress subscale total at 4 weeks
|
16.9 score on a scale
Standard Deviation 8.0
|
17.3 score on a scale
Standard Deviation 11.2
|
|
Depression Anxiety Stress Scale-21 Stress Subscale Change
DASS-21 Stress subscale total at 8 weeks
|
11.7 score on a scale
Standard Deviation 6.9
|
17.0 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed each assessment
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Overall Anxiety Severity and Impairment Scale Change
OASIS total at Baseline
|
9.4 score on a scale
Standard Deviation 3.9
|
9.4 score on a scale
Standard Deviation 2.8
|
|
Overall Anxiety Severity and Impairment Scale Change
OASIS total at 4 weeks
|
6.2 score on a scale
Standard Deviation 3.3
|
8.2 score on a scale
Standard Deviation 3.8
|
|
Overall Anxiety Severity and Impairment Scale Change
OASIS total at 8 weeks
|
5.5 score on a scale
Standard Deviation 3.4
|
8.0 score on a scale
Standard Deviation 4.6
|
|
Overall Anxiety Severity and Impairment Scale Change
OASIS total at 12 weeks
|
4.8 score on a scale
Standard Deviation 3.7
|
8.2 score on a scale
Standard Deviation 4.0
|
|
Overall Anxiety Severity and Impairment Scale Change
OASIS total at Post-assessment (16 weeks)
|
4.1 score on a scale
Standard Deviation 3.8
|
7.4 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, & Post-Assessment (at 16 weeks)Population: Enrolled participants who completed each assessment
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Overall Depression Severity and Impairment Scale Change
ODSIS total at Baseline
|
6.5 score on a scale
Standard Deviation 4.3
|
6.2 score on a scale
Standard Deviation 4.5
|
|
Overall Depression Severity and Impairment Scale Change
ODSIS total at 4 weeks
|
4.3 score on a scale
Standard Deviation 3.7
|
5.3 score on a scale
Standard Deviation 4.4
|
|
Overall Depression Severity and Impairment Scale Change
ODSIS total at 8 weeks
|
3.9 score on a scale
Standard Deviation 3.5
|
5.6 score on a scale
Standard Deviation 5.5
|
|
Overall Depression Severity and Impairment Scale Change
ODSIS total at 12 weeks
|
2.7 score on a scale
Standard Deviation 3.3
|
6.2 score on a scale
Standard Deviation 5.3
|
|
Overall Depression Severity and Impairment Scale Change
ODSIS total at Post-assessment (16 weeks)
|
3.0 score on a scale
Standard Deviation 3.7
|
5.0 score on a scale
Standard Deviation 4.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline & Post-Assessment (at 16 weeks)Population: Enrolled Participants who completed 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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=11 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=17 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment
Q-LES-Q-SF total at Baseline
|
44.9 score on a scale
Standard Deviation 8.5
|
43.8 score on a scale
Standard Deviation 7.4
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form at Post-Assessment
Q-LES-Q-SF total at Post (16 weeks)
|
49.9 score on a scale
Standard Deviation 8.1
|
48.7 score on a scale
Standard Deviation 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-assessment (16 weeks)Population: All participants who enrolled in the study
This feasibility outcome measure is the number who attended one or more treatment sessions
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Engagement in Treatment
|
15 participants
|
13 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-assessment (16 weeks)Population: All participants enrolled in the study
This feasibility measure is the number of treatment sessions completed during the 16-week active treatment phase
Outcome measures
| Measure |
Brief Anxiety Intervention
n=17 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Number of Treatment Sessions Completed
|
4.7 sessions
Standard Deviation 2.2
|
1.8 sessions
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-assessment (at 16 weeks)Population: All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=10 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=13 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Treatment Satisfaction
|
29.80 score on a scale
Standard Deviation 2.82
|
24.23 score on a scale
Standard Deviation 5.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-assessment (16 weeks)Population: All participants who completed the Post-assessment (at 16 weeks) and reported attending at least one treatment session
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=10 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=13 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Treatment Credibility
|
34.20 score on a scale
Standard Deviation 5.51
|
22.31 score on a scale
Standard Deviation 11.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-assessment (16 weeks)Population: All participants who completed Post-assessment (16 weeks) and reported attending at least one treatment session
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.
Outcome measures
| Measure |
Brief Anxiety Intervention
n=10 Participants
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=13 Participants
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Therapeutic Alliance
|
55.00 score on a scale
Standard Deviation 5.54
|
42.62 score on a scale
Standard Deviation 9.73
|
Adverse Events
Brief Anxiety Intervention
Usual PC-MHI Care
Serious adverse events
| Measure |
Brief Anxiety Intervention
n=17 participants at risk
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 participants at risk
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.00%
0/17 • Adverse event data were collected over the course of a participant's study participation, 16 weeks.
n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected over the course of a participant's study participation, 16 weeks.
n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
|
Other adverse events
| Measure |
Brief Anxiety Intervention
n=17 participants at risk
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
Brief anxiety intervention: Modular anxiety intervention, tailored for Veterans, with emphasis on adaptive coping skills
|
Usual PC-MHI Care
n=18 participants at risk
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
Usual PC-MHI care: Anxiety treatment with mental health provider in local primary care clinic
|
|---|---|---|
|
Social circumstances
Symptom exacerbation
|
5.9%
1/17 • Number of events 1 • Adverse event data were collected over the course of a participant's study participation, 16 weeks.
n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
|
0.00%
0/18 • Adverse event data were collected over the course of a participant's study participation, 16 weeks.
n/a (same definitions as clinicaltrials.gov). Adverse event collection included systematic assessment (e.g., anxiety and depressive symptoms assessed at each treatment session in intervention condition and at each study assessment) and non-systematic assessment (e.g., participant self-report, information in participant medical record).
|
Additional Information
Dr. Robyn L. Shepardson
VA Center for Integrated Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place