Reducing Anxiety and Stress in Primary Care Patients

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.