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Cognitive Computer Training in Patients With Depression

29. Juni 2016 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 63 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
Sonstiges: 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.
Andere Namen:
  • Cognifit personalized training
Kein Eingriff: cogntrol group
The control group do not receive cognitive computer training for three months

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Employment status of the participants at nine months follow-up
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: approximately nine months
Executive function is measured by The Tower of London
approximately nine months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Compliance of cognitive computer training
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: approximately nine months
The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
approximately nine months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Southern Denmark

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2015

Primärer Abschluss (Voraussichtlich)

1. Oktober 2017

Studienabschluss (Voraussichtlich)

1. Oktober 2017

Studienanmeldedaten

Zuerst eingereicht

6. Juni 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2016

Zuerst gepostet (Schätzen)

4. Juli 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

4. Juli 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2016

Zuletzt verifiziert

1. Juni 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Cognex-depression

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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