Trial · NCT04836533
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (HRSD) Change | Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 | Clinician-rated measure of depressive severity composed of 24 questions used to measure changes in depressive symptoms and monitor safety during the study. |
| Primary | Treatment Credibility Expectancy Scale (CES) - item 4 Change | Baseline, Week 0 | Self-report scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. Item 4 measures how much improvement in depression symptoms is expected. |
| Primary | Processing Speed Change - WAIS-IV Coding | Baseline, Weeks 4, 12 | Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. |
| Primary | Processing Speed Change - NIHH Toolbox Pattern Comparison Processing Speed Test | Baseline, Weeks 4, 12 | Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. |
| Primary | Processing Speed Change - Trail Making Test A | Baseline, Weeks 4, 12 | Processing speed will be assessed using Coding from the Wechsler Adult Intelligence Scale-IV (WAIS-IV), the NIH Toolbox Pattern Comparison Processing Speed Test, and Trail Making Test A. From these 3 tests, a composite score (primary outcome) is derived by extracting a latent factor and factor loadings, creating a purer measure of processing speed than raw scores from an individual test or a sum total score. |
| Primary | Resting State Functional Connectivity Index Change | Baseline, Week 4 | Measure of resting state fMRI. |
| Secondary | Secondary Clinical Global Impressions (CGI) Severity and Improvement | Screen, Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 | Scales measuring the clinician's view of subjects' global functioning that will provide a clinical assessment of subjects at each visit and help maintain safety by identifying clinical worsening. |
| Secondary | Inventory for Depressive Symptomatology Self-Report (IDS-SR) | Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12 | The IDS-SR is a standard self-report measure of depression severity that will be used to measure changes in depressive symptoms and monitor safety during the study. |
| Secondary | Cumulative Illness Rating Scale for Geriatrics (CIRS-G) | Screen | Provides quantitative ratings of chronic illness burden. Presence of illness is rated from 0 to 4 in 14 different medical domains. Scores range from 0-56. |
| Secondary | NIH Toolbox Auditory Verbal Learning Test - Rey (RAVLT) | Baseline, Weeks 4, 12 | Measures immediate recall. Unrelated words presented via audio recording and participant recalls as many as possible |
| Secondary | Stroop Color-Word Test (Stroop) | Measure of response inhibition sensitive to frontal lobe dysfunction. This test is divided into three conditions: color naming, word reading, and colorword inhibition. | Baseline, Weeks 4, 12 |
| Secondary | Letter and Animal Naming Test | Baseline, Weeks 4, 12 | Test measuring the verbal fluency component of executive functioning. Requires subjects to generate words that begin with a particular letter or belong to a particular semantic category as quickly as possible |
| Secondary | World Health Organization Disability Assessment Schedule 2.0 (WHODAS2.0) | Screen, Weeks 4, 6, 8, 10, 12 | This 36-item self-report provides a global measure of disability and 7 domain-specific scores based on the conceptual framework of the International Classification of Functioning, Disability, and Health (ICF). |
| Secondary | Trail Making Test A and B | Baseline, Weeks 4, 12 | Paper and pencil test that assesses (A) speeded attention and (B) the switching component of executive function. This test has two conditions: (A) number sequencing and (B) number-letter sequencing. |
| Secondary | NIH Toolbox Flanker Inhibitory Control and Attention Test | Baseline, Weeks 4, 12 | Measures attention and executive functioning. The allocation of one's limited capacities to deal with an abundance of environmental stimulation |
| Secondary | NIH Toolbox Picture Sequence Memory Test | Baseline, Weeks 4, 12 | Measures episodic memory. Cognitive processes involved in the acquisition, storage, and retrieval of new information. |
| Secondary | NIH Toolbox List Sorting Working Memory Test | Baseline, Weeks 4, 12 | Measures working memory. The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. |
| Secondary | NIH Toolbox Picture Vocabulary Test | Baseline, Weeks 4, 12 | Measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word. |
| Secondary | NIH Toolbox Oral Reading Recognition Test | Baseline, Weeks 4, 12 | Measures reading and decoding skill and crystallized abilities. Participant is asked to read and pronounce letters and words as accurately as possible. |
| Secondary | NIH Toolbox Dimensional Card Change Sort Test | Baseline, Weeks 4, 12 | Measures executive function. The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner. |
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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