Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1 |
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
Baseline to 1-Month Post Experimental Session 2 (End of Stage 1) |
|
Secondary |
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2 |
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
End of Stage 1 to End of Stage 2 |
|
Secondary |
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up |
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
Baseline to 12 months post-final experimental session |
|
Secondary |
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1 |
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. |
Baseline to 1-Month Post Experimental Session 2 (End of Stage 1) |
|
Secondary |
Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2 |
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. |
End of Stage 1 to End of Stage 2 |
|
Secondary |
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up |
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. |
Baseline to 12 month post-final experimental session |
|
Secondary |
Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1 |
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning. |
Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) |
|
Secondary |
Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2 |
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning. |
End of Stage 1 to End of Stage 2 |
|
Secondary |
Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up |
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning. |
Baseline to 12 months post-final experimental session |
|
Secondary |
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1 |
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms. |
Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) |
|
Secondary |
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2 |
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms. |
End of Stage 1 to End of Stage 2 |
|
Secondary |
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up |
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms. |
Baseline to 12 months post-final experimental session |
|
Secondary |
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1 |
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality. |
Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) |
|
Secondary |
Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2 |
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality. |
End of Stage 1 to End of Stage 2 |
|
Secondary |
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up |
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality. |
Baseline to 12 months post-final experimental session |
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