COVID-19 and Brain: Cognition and Mental Health
NCT05307549, Completed, University of Barcelona
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | COVID-19 and Brain: Cognition and Mental Health | ClinicalTrials.gov |
| NCT number | NCT05307549 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 200 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Barcelona | ClinicalTrials.gov |
| Conditions | COVID-19 | ClinicalTrials.gov |
| First posted | 2022-04-01 | ClinicalTrials.gov |
| Last updated | 2023-05-30 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Differences between groups in auditory attention | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Auditory attention is measured with Digit Span Forward. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in working memory | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Working memory is measured with Digit Span Backward. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in language | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Language is measured with the Boston Naming Test. It consists of 60 line drawings of objects of graded difficulty, ranging from very common things to less familiar objects. The total score is the sum of correct answers. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in verbal memory | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in visual memory | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Visual memory is measured with the Rey-Osterrieth Complex Figure (ROCF) test. The participants are asked to copy complex geometric shapes and then reproduce them from memory. A delayed recall is also tested. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in psychomotor speed | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Processing speed is measured with Coding subtest of WAIS. Participants are asked to use a key to put in the appropriate symbols for a list of numbers. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in perceptual reasoning | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Perceptual reasoning is measured with Matrix reasoning subtest of WAIS. Participants are asked to choose which of some possible options the missing picture is from matrix of abstract pictures. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in executive function | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | A composite score is made with the z-scores of phonemic (sum of the three letters) and semantic fluency, Trail Making Test B (time) and STROOP test (color-word interference total items in 120 seconds). | ClinicalTrials.gov |
| Primary | Differences between groups in social cognition | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Social cognition is measured with the Reading the Mind in the Eyes Test. Participants are asked to choose the emotional state that best describes the eyes, choosing between one of four possible emotions in the 36 photographs of male and female eyes depicting emotional states. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in anxiety | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in depression | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome. | ClinicalTrials.gov |
| Primary | Differences between groups in Post-traumatic Stress Disorder | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Post-Traumatic Stress Disorder is measured with The Post-Traumatic Stress Disorder Checklist (PCL-5), a 20-item questionnaire corresponding to the DSM-5 symptom criteria for PTSD, which scores each criterion as "not at all" (0 points) to "extremely" (4 points). The ratings of items are added together to calculate the total score (range=0-80). Higher scores mean a worse outcome. | ClinicalTrials.gov |
| Secondary | Differences between groups in Fatigue | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Fatigue is measured with the Chalder Fatigue Scale, an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item " less than usual" (0) to " much more than usual" (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue. | ClinicalTrials.gov |
| Secondary | Differences between groups in Quality of Life | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Quality of life is measured with a 12-item World Health Organization Disability Assessment Schedule-II (WHODAS-II). Patients are asked to state the level of difficulty experienced, considering how they usually do the activity. The scale scores each item as "none" (1) to "cannot do" (5). The total score is calculated with an SPSS syntax, and the range varies from 0 to 100, with higher scores reflecting more significant disability. (WHODAS-II) | ClinicalTrials.gov |
| Secondary | Differences between groups in White Matter integrity | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | White matter integrity: tractography measured by MRI | ClinicalTrials.gov |
| Secondary | Differences between groups in brain Volumetry | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Grey and white matter volume measured by MRI | ClinicalTrials.gov |
| Secondary | Differences between groups in Resting-state connectivity | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | Resting state brain activity using fMRI | ClinicalTrials.gov |
| Secondary | Differences between groups in plasmatic Interleukin- 6 (IL-6) | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | The plasma levels of IL-6 are measured with enzyme-linked immunosorbent assay (ELISA) Kit | ClinicalTrials.gov |
| Secondary | Differences between groups in plasmatic D-Dimer | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | The plasma levels of D-Dimer are measured with ELISA Kit | ClinicalTrials.gov |
| Secondary | Differences between groups in plasmatic Nerve Growth Factor (NGF) | At the time of inclusion of the participant, between 3 and 12 months from the start of COVID-19 | The plasma levels of NGF are measured with ELISA Kit | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Matrix Reasoning | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)