Cognitive Computer Training in Patients With Depression
29. juni 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Region of southern Denmark
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Odense C, Region of southern Denmark, Danmark, 5000
- Rekruttering
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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Ta kontakt med:
- Anja F Elliott, BACH.MED.
- Telefonnummer: +4560795724
- E-post: anjaelliott@hotmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 63 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
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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 navn:
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Ingen inngripen: cogntrol group
The control group do not receive cognitive computer training for three months
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Employment status of the participants at nine months follow-up
Tidsramme: When the study is completed, approximately 15 months
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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.
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When the study is completed, approximately 15 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
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Concentration is measured by The Digit Span Test
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approximately nine months
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The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Tidsramme: approximately nine months
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Attention is measured by The Letter Cancellation Test
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approximately nine months
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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
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Working memory is measured by The Letter Number Sequencing
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approximately nine months
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The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsramme: approximately nine months
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Learning is measured by the Rey Auditory Verbal Learning Test.
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approximately nine months
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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
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Executive function is measured by The Verbal Fluency
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approximately nine months
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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
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Psychomotor speed is measured by The Trial Making Test (TMT).
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approximately nine months
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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
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Executive function is measured by The Tower of London
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approximately nine months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Compliance of cognitive computer training
Tidsramme: approximately nine months
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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.
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approximately nine months
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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
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The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
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approximately 15 months
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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
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The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
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approximately nine months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bent Nielsen, Prof.MD, University of Southern Denmark
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2015
Primær fullføring (Forventet)
1. oktober 2017
Studiet fullført (Forventet)
1. oktober 2017
Datoer for studieregistrering
Først innsendt
6. juni 2016
Først innsendt som oppfylte QC-kriteriene
29. juni 2016
Først lagt ut (Anslag)
4. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2016
Sist bekreftet
1. juni 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Cognex-depression
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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