Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Cognitive Training for Nicotine Dependence

12. januar 2017 opdateret af: University of Pennsylvania

This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.

All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

213

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion:

  1. Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months
  2. Plan to live in the area for at least the next 8 months
  3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form
  4. Able to communicate fluently in English (speaking, writing, and reading)
  5. Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection
  6. Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive Training
Participants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling.
Adfærdsmæssigt: Cognitive Training
The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
Placebo komparator: Control Training
Participants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling
Adfærdsmæssigt: Control training
The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Point-prevalence Abstinence at End of Treatment
Tidsramme: End of treatment (Week 12)
Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.
End of treatment (Week 12)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Point-prevalence Abstinence at 6-month Follow-up
Tidsramme: 6 month follow-up
Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.
6 month follow-up
Cognitive Performance (Working Memory)
Tidsramme: Baseline and Week 12 (EOT)
Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.
Baseline and Week 12 (EOT)
Cognitive Performance (Response Inhibition)
Tidsramme: Baseline and Week 12 (EOT)
Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word "PRESS" in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change.
Baseline and Week 12 (EOT)
Cognitive Performance (Attention)
Tidsramme: Baseline and Week 12 (EOT)
Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.
Baseline and Week 12 (EOT)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Caryn Lerman, PhD, University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. marts 2011

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

1. december 2010

Først indsendt, der opfyldte QC-kriterier

1. december 2010

Først opslået (Skøn)

3. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 812429

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cognitive Training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ethiopia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner