Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
IL-6 Saliva Elisa |
Tests for levels human Interleukin-6 |
Change from Week 1 to twice during Week 5 conducted before and after TSST |
|
Primary |
Salimetrics Cortisol EIA Test |
Tests for salivary cortisol levels |
Change from Week 1 to twice during Week 5 conducted before and after TSST |
|
Secondary |
Generalized Anxiety Disorder 7 (GAD-7)- Spitzer et al. 2006 |
Assesses anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. Scores above 10 are considered to be in the clinical range. |
Within first four weeks before study commences, then change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
Somatic Symptom Scale 8 (SSS-8)- Gierk et al. 2014 (A brief version of the popular Patient Health Questionnaire - 15) |
Assesses presence and severity of common somatic symptoms. A score of 0 to 3 points were classified as "no to minimal" severity, a score of 4 to 7 points as "low," a score of 8 to 11 points as "medium," a score of 12 to 15 points as "high," and a score of 16 points or higher as "very high." |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
Pittsburgh Sleep Quality Index (PSQI)- Buysse 1989 |
Assesses sleep quality. The PSQI includes a scoring key for calculating a patient's seven sub scores, each of which can range from 0 to 3. The sub scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
5 Facet Mindfulness Questionnaire Short Form (FFMQ)- Bohlmeijer et al. 2011 |
Assesses 5 facets of mindfulness- observation, description, awareness of actions, non-judgement and non-reaction. Items scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores were computed by summing the scores on the individual items. Facet scores range from 8 to 40 (except for the nonreactivity facet, which ranges from 7 to 35), with higher scores indicating more mindfulness. |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
Perceived Stress Scale 10 (PSS-10)- Cohen, Kamarck and Mermelstein 2016 |
Assesses perceptions of stress. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
Patient Health Questionnaire 9 (PHQ-9)- Kroenke et al. 1999 |
Measures depression severity. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 0- not at all, 1- several days, 2- more than half the days, 3- nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27. 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
Oldenburg Burnout Inventory (OBI)- Demerouti & Bakker 2007 |
Assesses burnout via disengagement and exhaustion. The subject is presented with a series of 16 statements, which they may agree or disagree with and is asked to indicate the degree of agreement or disagreement. The 16 items are divided between two subscales, the items are also summed to form two sub-totals. Disengagement items: 1, 3, 6, 7, 9, 11, 13 and 15; Exhaustion items: 2, 4, 5, 8, 10, 12, 14 and 16. For items 2, 3, 4, 6, 8, 9, 11 and 12, the scale is reversed, with Strongly Agree answers scoring 4 and Strongly Disagree answers scoring 1. A total OLBI score can be reached by summing the two sub-totals. The higher the score, the greater the level of burnout. Some therapists may categorize the OLBI scores under low, medium or high but no widespread consensus exists. |
Change from Week 1, to during Week 5, and then to 6 week follow-up |
|
Secondary |
The DSM-5 Level 1 Cross-Cutting Symptom Measure (DSM5_Level 1) |
Consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Nineteen of the 25 items on the measure are each rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The higher the score the more severity of the symptoms. The suicidal ideation, suicide attempt, and substance abuse items are each rated on a "Yes, No, or Don't Know" scale. |
Within first four weeks before study commences |
|