Cognitive Computer Training in Patients With Depression
29 juni 2016 uppdaterad 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Region of southern Denmark
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Odense C, Region of southern Denmark, Danmark, 5000
- Rekrytering
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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Kontakt:
- Anja F Elliott, BACH.MED.
- Telefonnummer: +4560795724
- E-post: anjaelliott@hotmail.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 63 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
|
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.
Andra namn:
|
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Inget ingripande: cogntrol group
The control group do not receive cognitive computer training for three months
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Employment status of the participants at nine months follow-up
Tidsram: 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.
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When the study is completed, approximately 15 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Tidsram: approximately nine months
|
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
Tidsram: approximately nine months
|
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.
Tidsram: 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.
Tidsram: 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.
Tidsram: approximately nine months
|
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.
Tidsram: approximately nine months
|
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.
Tidsram: approximately nine months
|
Executive function is measured by The Tower of London
|
approximately nine months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Compliance of cognitive computer training
Tidsram: 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
|
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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.
Tidsram: 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.
Tidsram: approximately nine months
|
The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
|
approximately nine months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Bent Nielsen, Prof.MD, University of Southern Denmark
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2015
Primärt slutförande (Förväntat)
1 oktober 2017
Avslutad studie (Förväntat)
1 oktober 2017
Studieregistreringsdatum
Först inskickad
6 juni 2016
Först inskickad som uppfyllde QC-kriterierna
29 juni 2016
Första postat (Uppskatta)
4 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2016
Senast verifierad
1 juni 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Cognex-depression
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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