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Cognitive Computer Training in Patients With Depression

29. juni 2016 opdateret af: Kjeld Andersen, University of Southern Denmark

Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression

Cognitive impairment plays an important role in functional recovery and leads to long-term sickness absence. Therefore there is a need of a treatment specifically improving cognitive functions. In this pilot study the investigators aim to evaluate the feasibility of using cognitive computer training in patients with unipolar depression to enhance cognitive performance. Further the investigators investigate whether this intervention shortens sick leave.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will evaluate cognitive computer training on patients in remission from depression by measuring the compliance and effect, investigating whether patients returned earlier to work and examine patients' physical and psychological health. This is done by comparing an intervention group and a control group.

Outpatients from psychiatric department Odense in Denmark will be recruited from December 2015 to July 2017.

At enrolment the participants wil be randomized 1:1 to either the intervention group or the control group. After the participants will complete a clinical interview and answer the The Short Form (36) Health Survey (SF-36) questionnaire. The participants' cognitive function and depression severity will be measured at baseline and three months follow-up. At nine months follow-up the participants will receive an email with the SF-36 questionnaire and questions about their education and work status, which they were required to answer.

The intervention is a cognitive computer program, consisting of different computer games. The intervention will start at enrolment and finish at the three months follow-up. The participants in the intervention group will do trainings session lasting 10-20 minutes three times a week. Each participant ends up with a total of 36 training sessions.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
    • Region of southern Denmark
      • Odense C, Region of southern Denmark, Danmark, 5000
        • Rekruttering
        • Research Unit of Psychiatry, Psychiatric Unit Odense - University function
        • Kontakt:

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

20 år til 63 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • a diagnosis of a moderate to severe unipolar depression according to the International Classification of Diseases -10 criteria
  • receiving antidepressant medicine
  • completed their treatment for depression
  • not be in any risk of suicide
  • study or work on reduced hours, be unemployed or on long-term sickness leave at enrolment.

Exclusion Criteria:

  • neurological disease of the central nervous system
  • alcohol or substance abuse
  • pregnancy
  • receiving disability pension
  • receiving electroconvulsive therapy within the last 6 weeks.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
Andet: Cognitive computer training
COGNIFIT is cognitive computer training. Its purpose is to improve cognitive function and is designed to accommodate each individual's cognitive strengths and weaknesses. The cognitive computer training last three months and must be done three times a week, in session lasting 10-20 minutes.
Andre navne:
  • Cognifit personalized training
Ingen indgriben: cogntrol group
The control group do not receive cognitive computer training for three months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Employment status of the participants at nine months follow-up
Tidsramme: When the study is completed, approximately 15 months
Questionnaire about employment status and will be send to the participants via email at nine months follow-up. The questionnaire include questions according to: current working situation; why they are not working; when they started working; do they work at the same workplace; do they have the same work assignments as before they got ill; do whey work the same number of hour as before the got ill.
When the study is completed, approximately 15 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Concentration is measured by The Digit Span Test
approximately nine months
The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Tidsramme: approximately nine months
Attention is measured by The Letter Cancellation Test
approximately nine months
The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Working memory is measured by The Letter Number Sequencing
approximately nine months
The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Learning is measured by the Rey Auditory Verbal Learning Test.
approximately nine months
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Executive function is measured by The Verbal Fluency
approximately nine months
The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Psychomotor speed is measured by The Trial Making Test (TMT).
approximately nine months
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
Executive function is measured by The Tower of London
approximately nine months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compliance of cognitive computer training
Tidsramme: approximately nine months
The participants were supposed to do 36 sessions of cognitive computer training during three months. The actual completed trainings sessions are available on the website of the cognitive computer training, called COGNIFIT. The compliance is defined as the percentage of actual completed training sessions of the 36 sessions of training.
approximately nine months
The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately 15 months
The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
approximately 15 months
The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
approximately nine months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Southern Denmark

Efterforskere

  • Ledende efterforsker: Bent Nielsen, Prof.MD, University of Southern Denmark

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. december 2015

Primær færdiggørelse (Forventet)

1. oktober 2017

Studieafslutning (Forventet)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

6. juni 2016

Først indsendt, der opfyldte QC-kriterier

29. juni 2016

Først opslået (Skøn)

4. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Cognex-depression

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Depression i remission

Kliniske forsøg med Cognitive computer training

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