Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Anxiety Sensitivity Index (ASI-3) |
A 18-Item self-report measure to assess symptoms of anxiety. Each question is rated on a 5-point scale, where 0 = very little, 1 = a little, 2 = some, 3 = much, and 4 = very much. Greater scores on the scale indicate more severe anxiety symptoms. |
Baseline to Treatment End (30 days) |
|
| Other |
Positive and Negative Affect Schedule (PANAS) |
A 20-Item self-reported assessment of positive (10 items) and negative affect (10 items). Each question is rated on a 5-point scale, where 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit, and 5 = extremely. Greater scores indicate greater positive or negative affect. |
Baseline to Treatment End (30 days) |
|
| Other |
Beck Depression Inventory II (BDI-II) |
A 21-Item self-report measure to assess symptoms of depression. Each question is rated on a 4-point scale, where greater scores indicate greater depressive symptoms. |
Baseline to Treatment End (30 days) |
|
| Other |
Patient Health Questionnaire (PHQ-2) |
A 2-Item health questionnaire that measures the frequency of depressed mood and anhedonia. Each question is rated on a 4-point scale, where 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. Greater scores indicate more severe symptom severity. |
Baseline to Treatment End (30 days) |
|
| Primary |
The Liebowitz Social Anxiety Scale (LSAS) |
A 24-item, self-rated scale to assess social anxiety in situations as well as the level of avoidance of those situations. Each question is rated on a 4-point scale, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Greater scores indicate greater symptom severity. |
Baseline to Treatment End (30 days) |
|
| Secondary |
The Liebowitz Social Anxiety Scale (LSAS) |
A 24-item, self-rated scale to assess social anxiety in situations as well as the level of avoidance of those situations. Each question is rated on a 4-point scale, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Scores above 55 indicate social phobia. |
Bi-weekly time point and at the 6 and 12 month follow-ups |
|
| Secondary |
Generalized Anxiety Disorder - 7 (GAD-7) |
A 7-item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. Scores range from 0-21, where greater scores indicate greater anxiety symptoms. |
Bi-weekly time point and at the 6 and 12 month follow-ups |
|
| Secondary |
Beck Anxiety Inventory (BAI) |
A 21-Item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = mildly but it didn't bother me much, 2 = moderately - it wasn't pleasant at times, and 3 = severely, it bothered me a lot. Higher scores indicate more severe anxiety symptoms. |
Baseline to Treatment End (30 days) |
|
| Secondary |
State-Trait Anxiety Scale (STAI) |
A 40-Item self-report measure to assess symptoms of state and trait anxiety. There are 20 questions for state anxiety and 20 questions assessing trait anxiety. Each question is rate on a 4-point scale, where 1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so. Greater scores indicate more severe anxiety symptoms. |
Baseline to Treatment End (30 days) |
|
| Secondary |
Hamilton Anxiety Rating Scale (HAM-A) |
A 14-Item self-report measure to assess symptoms of anxiety. Each item is scored on a scale of 0 = not present to 4 = severe, with a total score range of 0-56. Greater scores indicate more severe anxiety symptoms. |
Baseline to Treatment End (30 days) |
|
| Secondary |
Depression, Anxiety, and Stress Scale (DASS-21) |
A 21-Item anxiety, depression, and stress measure. Consisted of anxiety, depression, and stress sub-scales. Each question is rated on a 4-point scale, where 0 = did not apply to me at all, 1 = applied to me to some degree, or some of the time, 2 = applied to me to a considerable degree or a good part of time, and 3 = applied to me very much or most of the time. Greater scores indicate greater symptom severity. Anxiety subscale only. |
Baseline to Treatment End (30 days) |
|
| Secondary |
Generalized Anxiety Disorder-7 (GAD-7) |
A 7-item self-report measure to assess symptoms of anxiety. Each question is rated on a 4-point scale, 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. Scores range from 0-21, where greater scores indicate greater anxiety symptoms. |
Baseline to Treatment End (30 days) |
|
