Cognitive Computer Training in Patients With Depression
29 juin 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Region of southern Denmark
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Odense C, Region of southern Denmark, Danemark, 5000
- Recrutement
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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Contact:
- Anja F Elliott, BACH.MED.
- Numéro de téléphone: +4560795724
- E-mail: anjaelliott@hotmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 63 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Aucune intervention: cogntrol group
The control group do not receive cognitive computer training for three months
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Employment status of the participants at nine months follow-up
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Compliance of cognitive computer training
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Bent Nielsen, Prof.MD, University of Southern Denmark
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2015
Achèvement primaire (Anticipé)
1 octobre 2017
Achèvement de l'étude (Anticipé)
1 octobre 2017
Dates d'inscription aux études
Première soumission
6 juin 2016
Première soumission répondant aux critères de contrôle qualité
29 juin 2016
Première publication (Estimation)
4 juillet 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 juillet 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juin 2016
Dernière vérification
1 juin 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Cognex-depression
Plan pour les données individuelles des participants (IPD)
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NON
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