Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Baseline in Symptoms on the Trauma Symptoms Checklist at Week 12 and 16. |
The Trauma Symptom Checklist is a validated, self-reported instrument assessing the frequency of a variety of trauma and trauma-related symptoms in the last month. Subscales include anxiety, depression, dissociation, sexual abuse trauma index, sexual problems, and sleep disturbances. Possible scores range from 0 (never occurring) to 3 (often occurring). Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Primary |
Change in Baseline in health and mental health ratings on the Medical Outcomes Study Questionnaire Short Form 36 Survey at Week 12 and 16. |
Questionnaire Short Form 36 Survey is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The Questionnaire Short Form 36 Survey has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Secondary |
Change in Baseline Alcohol Consumption on the Alcohol Use Disorders Identification Test (AUDIT questionnaire at week 12 and 16 |
The Alcohol Consumption on the Alcohol Use Disorders Identification Test questionnaire is designed to help in the self assessment of alcohol consumption and to point out any implications for the person's health and wellbeing now and in the future. Scores for each question range from 0 to 4, with the first response for each question (e.g., never) scoring 0, the second (e.g., less than monthly) scoring 1, the third (e.g., monthly) scoring 2, the fourth (e.g., weekly) scoring 3, and the last response (eg. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). Lower scores = less alcohol consumption, higher scores = higher alcohol consumption. Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Secondary |
Change in Baseline Resilience self-evaluation on the Brief Resilience Scale at week 12 and 16 |
The Brief Resilience Scale assesses the ability to bounce back or recover from stress. The scale consists of 6 questions, with questions 1, 3, and 5 that range from 1 (strongly disagree) to 5 (strongly agree). Questions 2, 4, 6 are rated inversely. Scoring includes adding the responses varying from 1-5 for all six items giving a range from 6-30. Divide the total sum by the total number of questions answered. Lower scores = less perceived resiliency, higher scores = higher perceived resiliency. Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Secondary |
Change in Baseline Stress on the Perceived Stress Scale at week 12 and 16 |
The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Lower scores = less perceived stress, higher scores = higher perceived stress. Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Secondary |
Change in Baseline Pessimism/Optimism on the Life Orientation Test at week 12 and 16 |
The Life Orientation Test is a 10-item scale that measures how optimistic or pessimistic people feel about the future. Of the 10 items, 3 items measure optimism, 3 items measure pessimism, and 4 items serve as fillers. Respondents rate each item on a 4-point scale: 0 = strongly disagree, 1 = disagree, 2 = neutral, 3 = agree, and 4 = strongly agree. Lower scores = more pessimistic, higher scores = more optimistic Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
|
| Secondary |
Change in Baseline on the perceived socials support Multidimensional Scale of Perceived Social Support at week 12 and 16 |
The Multidimensional Scale of Perceived Social Support is a brief research tool designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale. Respondents rate each item from a 1-7 scale, with lower scores = less perceived social support, higher scores = more perceived social support. Change = (Week 12 and 16 score - Baseline Score). |
Baseline and Weeks 12 and 16 |
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