Effectiveness of Cognitive Training in Older and Younger Adults

Официальное название

Examining the Effectiveness of Cognitive Training

Обзор

The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks.

Подробное описание

Participants will first complete two sessions (\~75 minutes each) where they are asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers. They will be asked to make some simple judgments about the stimuli (such as indicating whether the stimulus you observed is the same or different from that on a previous trial), and indicate their judgment decision with a button press on a keyboard, a mouse click, or a movement on a touchpad. They will also be asked to complete a set of questionnaires.

After the initial sessions, participants may be asked to complete two sets of 10 sessions (\~20 minutes) of cognitive tasks either at home or in the lab. Each set of sessions should be completed over a period of no more than 15 days. If asked to do these sessions, instructions will be given regarding the tasks to complete in these training sessions (which will be similar to some of the tasks you complete in the first two sessions, \~20 minutes) prior to these sessions.

After completing the first set of 10 sessions, participants will complete, either at home or in the lab, one session (\~75 minutes) of tasks similar to the first sessions. Participants who were not asked to complete the 20-minute sessions will complete another session two weeks after the first two 75-minute sessions in the same location as they completed the two 75-minute sessions.

Then, participants will complete the second set of ten 20-minute sessions, or wait for about two weeks for those not asked to complete the 20-minute sessions of cognitive tasks. After this, participants will complete two other sessions (\~75 minutes) in the same location as they completed the previous two 75-mintue sessions.

Finally, after a couple of weeks, participants will complete their two final testing sessions (\~45 minutes each) in the same location as they completed the previous two 75-mintue sessions.

The total duration of the study will be around 8 hours if not asked to complete the twenty 20-minute sessions, or 15 hours if asked to complete these sessions. The whole experiment runs over the course of 4 to 8 weeks.

\*To maintain scientific integrity, certain details of this study will not be shared until all data has been collected.

Вмешательства

• Поведенческое Visual and / or Auditory Cognitive Tasks (1)
  Seven sessions (\~45-75 minutes) of cognitive tasks in the lab. Participants asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers and asked to make simple judgements.
• Поведенческое Visual and / or Auditory Cognitive Tasks (2)
  Two sets of 10 sessions (\~20 minutes) of cognitive tasks either at home or in the lab. Participants asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers and asked to make simple judgements.

Первичные конечные точки

• Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the proportion of correctly reported sequences in the Corsi Complex task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the proportion of correctly reported number and letter sets in the Letter-Number task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the proportion of correct responses on the Useful Field of View (UFOV) Task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the response time and percentage of correct responses in the Mental Rotation Task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]
• Change in the percentage of correct responses in the Paper Folding task [Срок оценки: Pre-test (baseline), post-test1 up to 30 days, (unmasked) post-test2 up to 60 days]

Вторичные конечные точки (12)

• Big-5-Inventory 10-item version (BFI-10) Score [Срок оценки: Pre-Test]
• Behavioral Inhibition/Activation System (BIS/BAS) Score [Срок оценки: Pre-Test]
• Grit and Conscientiousness Score [Срок оценки: Pre-Test]
• Meta-Cognition Score [Срок оценки: Pre-Test]
• Theories of Intelligence - Mindset (Fixed vs Growth) Score [Срок оценки: Pre-Test]
• Schutte self-report emotional intelligence test (SSEIT) Score [Срок оценки: Pre-Test]
• Work and Family Orientation (WOFO) Score [Срок оценки: Pre-Test]
• Brief Pittsburgh Sleep Quality Index (B-PSQI) Score [Срок оценки: Pre-Test]
• Participant Experience Measure 1 [Срок оценки: End of Post-Test (up to 60 days)]
• Participant Experience Measure 2 [Срок оценки: End of Post-Test (up to 60 days)]
• Participant Experience Measure 3 [Срок оценки: End of Post-Test (up to 60 days)]
• Participant Experience Measure 4 [Срок оценки: Beginning of Post-Test (up to 60 days)]

Критерии участия

Критерии включения

• Self-reported normal or corrected-to-normal vision
• No known neurological impairments
• Age within inclusion range (18-30 Years for Younger Adults and 60-85 Years for Older Adults)

Критерии исключения

• Physical handicap (motor or perceptual) that would impede training procedures
• Concurrent enrollment in other cognitive training studies
• Not being proficient enough in English that would prevent following and understanding all instructions and completing all testing sessions (typically, participants would need to have learned English before age 11; there might be some exceptions that will be decided on a case-by-case basis).
• Unable to adhere to training schedule

Additional exclusion criteria for older adults:

\- Score < 17 (out of 22) on the Telephone Montreal Cognitive Assessment (T-MoCA).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 3 центра

• University of California, Riverside — Riverside
• Northeastern University — Boston
• University of Wisconsin - Madison — Madison

Идентификаторы

NCT: NCT06375681 · 2019-1378: R01 · 1R01AG076157-01 · A487400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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