Trial · NCT04989972
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Beck Anxiety Inventory BAI | Screening to week 16 | Measures 21 items in physical and cognitive anxiety ranges 0-7 mild, to 26-63 severe Questionnaire BDI-11 |
| Primary | Changes in Beck Depression Inventory 02 - BDI-II | screening to week 16 | Measures 21 items in the presence and severity of depressive symptoms 0-9 no depression, 10 -18 mild depression, 19-29 moderate to severe depression |
| Secondary | Change in the European Quality of life 5 dimensions- EQ-5D | screening to week 16 | changes between the intervention PSIL-428 and placebo groups for mobility, self-care, pain \& discomfort, usual activities and anxiety \& depression |
| Secondary | Cognitive flexibility, using the Stroop Color & Word Test (SCWT) | Screening to week 16 | Changes in cognition between the PSIL-428 and placebo groups in the reading of words as compared to identifying \& naming colors. A stopwatch is used and the test-taker reads color words or names ink colors from different pages as quickly as possible. An interference score, cognitive flexibility, creativity and reaction to cognitive pressure are measured |
| Secondary | Changes in resilience using the Brief Resiliency Scale | Screening to 16 weeks | assesses the ability of the individual to bounce back or recover from stress a score of one means low resiliency and a score of 5 means high resiliency |
| Secondary | Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test | screen to 16 weeks | Uses two card packs, having 4 stimulus cards and 64 response cards measures attention, perseverance , abstract thinking and set shifting. |
| Secondary | The incidence of adverse events | Screening to 16 weeks | The number of reported cases of adverse events |
| Secondary | The severity of adverse events | Screening to 16 weeks | Adverse events which range from mild,moderate, severe and lethal |
| Secondary | Incidence of abnormal blood pressure | Screening to 16 weeks | Blood pressure which is consistently above and below120/80 |
| Secondary | Incidence of abnormal heart rate | Screening to 16 weeks | The incidence of atrial fibrillation, supraventricular tachycardia or bradycardia |
| Secondary | incidence of irregular heart rate | Screening to 16 weeks | incidence of arrhythmias |
| Secondary | incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale | Screening to 16 weeks | Measures Suicidal Ideation items 1-5; Suicidal Behavior 6-10 and both Suicidal Ideation and Behavior Items 1-10 |
| Secondary | Change in the number of steps | Screening to Week 16 | Wearable and or mobile devices |
| Secondary | Changes in concomitant medication | Screening to 16 weeks | Recently prescribed medication |
| Secondary | Changes in volume of Alcohol | screening to 16 weeks | self reports |
| Secondary | Changes in the number of cigarettes | screening to 16 weeks | self reports |
| Secondary | Changes in the number of cannabis joints | Screening to 16 weeks | Self reports |
| Secondary | Changes in other over the counter medication | Screening to 16 weeks | Self Reports |
| Secondary | Changes in Estradiol | Screening to 16 weeks | Salivary panel profile values |
| Secondary | Changes in Testosterone | Screening to 16 weeks | Salivary panel profile vales |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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