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Cognitive Computer Training in Patients With Depression

2016年6月29日 更新者：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.

調査の概要

状態

わからない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • デンマーク
    • Region of southern Denmark
      • Odense C、Region of southern Denmark、デンマーク、5000
        • 募集
        • Research Unit of Psychiatry, Psychiatric Unit Odense - University function
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年～63年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
他の：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.
他の名前：
  • Cognifit personalized training
介入なし：cogntrol group
The control group do not receive cognitive computer training for three months

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Employment status of the participants at nine months follow-up
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：approximately nine months
Executive function is measured by The Tower of London
approximately nine months

その他の成果指標

結果測定
メジャーの説明
時間枠
Compliance of cognitive computer training
時間枠：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.
時間枠：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.
時間枠：approximately nine months
The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
approximately nine months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Southern Denmark

捜査官

  • 主任研究者：Bent Nielsen, Prof.MD、University of Southern Denmark

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年12月1日

一次修了 (予想される)

2017年10月1日

研究の完了 (予想される)

2017年10月1日

試験登録日

最初に提出

2016年6月6日

QC基準を満たした最初の提出物

2016年6月29日

最初の投稿 (見積もり)

2016年7月4日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年7月4日

QC基準を満たした最後の更新が送信されました

2016年6月29日

最終確認日

2016年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Cognex-depression

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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