Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Hamilton Depression Rating Scale (HRSD-24) |
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson & Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
16-item Quick Inventory for Depression (QIDS-C16) |
Change in rater-assessed depression as measured by the 16-item Quick Inventory for Depression (QIDS-C16) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Total scores range from 0-27 with higher scores indicating more severe levels of depression. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Beck Depression Inventory (BDI) |
Change in self-assessed depression as measured by the Beck Depression Inventory (BDI) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The BDI is a 21-item self-report measure of depression symptoms. Total scores range from 0-63 with higher scores indicating more severe levels of depression. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Dysfunctional Attitudes Scale Form 18B (DAS-18B) |
Change in dysfunctional attitudes as measured by change in the Dysfunctional Attitudes Scale Form 18B (DAS-18B) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Each item is endorsed on a 7-point scale (Range: 0-7) such that a total score of 126 is possible with higher scores indicating dysfunctional beliefs which are held more strongly. The total score is comprised of two subscales (perfectionism (Range 0-56); need for social approval (Range 0-21)), which are summed along with 7 other items to calculate the total scale score. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Metacognitions Questionnaire (MCQ-30) |
Change in metacognitive beliefs as measured by change in the Metacognitions Questionnaire (MCQ-30) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The 30-item scale has a range of 30-120. The scale is comprised of five subscales (range for each = 6-24): (1) Positive Beliefs (PB) about worry (6 items); (2) Negative Beliefs (NB) about thoughts concerning uncontrollability and danger (6 items), and (3) beliefs about the need to control thoughts (Need for Control [NFC],6 items); (4) Cognitive Confidence (6 items) and Cognitive Self-Consciousness (6 items). Higher scores indicate more strongly held metacognitive beliefs. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Rosenberg Self-Esteem Scale |
Change in self-esteem as measured by change in the Rosenberg Self-Esteem scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Ruminative Responses Scale |
Change in rumination as measured by the Ruminative Responses Scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
World Health Organization Quality of Life-BREF - Item 1 |
Change in global quality of life as measured by change on item 1 on the World Health Organization Quality of Life-BREF from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Responses on the item range from 1 (very bad quality of life) to 5 (very good quality of life). |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Remission rate |
Remission rate at post-assesment (8 weeks) and follow-up (5 months) as measured by the Hamilton Depression Rating Scale (HDRS score = 8) |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
EurQoL Group 5Q 5D 5L |
Change in health status as assessed by change in percentage of participants experiencing health-related difficulties in 5 domains and change in overall health quality as assessed by change on the Visual Analogue rating Scale (VAS; range 0-100; higher scores indicate better quality of life) from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Trail-Making Test, Part B |
Change in executive functioning as measured by change in the Trail-Making Test, Part B (TMT-B) time to completion from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). A maximum of 300 seconds is allowed and shorter time indicating better performance. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Trail-Making Test, Part A |
Change in Information processing speed as measured by change in the the Trail-Making Test A (TMT-A) time to completion from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). A maximum of 300 seconds is allowed and shorter time indicating better performance. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Rivermead Behavioral Memory Test |
Change in memory functioning as measured by change in Rivermead Behavioral Memory Test (RBMT) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Total scores range from 0-24 with higher scores indicating better memory performance. |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
|
| Secondary |
Stroop Color-Word Task |
Change in executive functions as measured by the Stroop Color-Word test from baseline to post-assessment (8 weeks) and follow-up (5 months). The Stroop Color-Word test is comprised of three trials: Word Reading, Color Naming and Color-Word (CW) Naming. Per the Golden administration guidelines, total score for each subscale is the number of items completed within 45 seconds. For each condition, a raw score of 100 is possible (with a higher score indicating a better performance). For the current study, the Interference score will also be calculated, which is the difference between the expected CW Naming score and the predicted CW Naming score (which is predicted based on age and education; range is -29 to 30 such that larger scores indicate better performance). |
Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) |
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