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Mechanisms of Cognitive Change (CTCS)

21. september 2022 opdateret af: Michael L Thomas, Colorado State University
This study will determine whether targeted cognitive training, a low-cost and low-risk commercial cognitive remediation therapy, directly impacts therapeutic targets as well as secondary outcomes in college undergraduates. The active intervention will be compared to an active control condition (computer games). Participants will also attend CSU TILT (The Institute for Teaching and Learning) Academic Workshops.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary goal of this project is to investigate whether commercial cognitive remediation therapy improves cognitive functioning in college undergraduates. The secondary goal is to investigate neurophysiological, cognitive, and psychosocial mechanisms of change. The investigators will compare cognitive remediation therapy to computer games. The active control condition will allow the investigators to determine whether targeted cognitive training, as an adjunct to academic skills training provided by CSU TILT, provides significant improvement over computer games alone (which is also thought to provide some value as "brain training"). Participants who agree to enroll in the study will be randomized to one of two intervention arms: cognitive remediation (CR) or active control (AC). In the CR arm, participants will complete 20 hours of targeted cognitive training, in 30-min session, 5 days per week, over 8 weeks. The AC Arm will follow the same schedule, except that participants will complete video games (e.g., pong). All participants will repeat assessments at randomly determined midpoint, as well as after the 8 weeks of training have been completed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80523
        • Colorado State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år til 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • College undergraduate;
  • English fluency, and the ability to complete study requirements.

Exclusion Criteria:

  • College seniors (i.e., students with more than 89 credits at CSU);
  • Students who are concurrently enrolled in another study investigating the efficacy or effectiveness of novel learning or cognitive development techniques (not including tutoring or other existing programs available to CSU undergraduates);
  • Participants less than age 15.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive Remediation
Cognitive Remediation comprises of six exercises supplied by BrainHQ by Posit Science Corporation: Sound Sweeps (targets auditory processing speed): Two successive frequency-modulated tone sweeps are presented and participants indicate whether the frequency increased or decreased within each tone: Fine Tuning (targets auditory perception and processing speed): Participants indicate which one of two confusable syllables were presented; Syllable Stacks (targets auditory memory); Users report the order of presented syllables in a serial memory span task; Memory Grid (targets auditory memory); Participants match identical cards representing syllables; To do List Training (targets auditory memory): Participants see a g rid of everyday items (e.g., plant, carrots, shovel) and select the items in accordance with spoken instructions; Rhythm Recall (target auditory memory): Participants recreate auditory melodies
Adfærdsmæssigt: Cognitive Remediation
See Cognitive Remediation Arm description.
Aktiv komparator: Active Control
Active Control Comprises six exercises also supplied by Post Science Corporation: A Maze Race, Reversi, Bricks Breaking Hex, Word Search II, Bricks Squasher II, and CircloO. These are all common computer games freely offered online.
Adfærdsmæssigt: Active Control
See Active Control Arm description.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale Scores
Tidsramme: Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.
Change in MATRICS Consensus Cognitive Battery (MCCB) Verbal Learning Subscale. Demographically corrected T-scores (M = 50; SD = 10; higher better).
Three time points (1 week pre-randomization, mid-treatment [randomly selected for each participant between the 2nd and 7th week of treatment], and 1 week post-treatment) for all participants.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Academic Performance
Tidsramme: Semester data obtained yearly up to 8 years
Academic performance will be evaluated using participant grade point average improvement over the course of the study.
Semester data obtained yearly up to 8 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Colorado State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. september 2019

Primær færdiggørelse (Faktiske)

22. januar 2021

Studieafslutning (Faktiske)

22. januar 2021

Datoer for studieregistrering

Først indsendt

20. september 2019

Først indsendt, der opfyldte QC-kriterier

24. september 2019

Først opslået (Faktiske)

25. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19-8509H

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Betingelser

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Placeringer

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