Cognitive Computer Training in Patients With Depression
2016년 6월 29일 업데이트: 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.
연구 개요
상태
알려지지 않은
개입 / 치료
상세 설명
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.
연구 유형
중재적
등록 (예상)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Region of southern Denmark
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Odense C, Region of southern Denmark, 덴마크, 5000
- 모병
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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연락하다:
- Anja F Elliott, BACH.MED.
- 전화번호: +4560795724
- 이메일: anjaelliott@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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간섭 없음: cogntrol group
The control group do not receive cognitive computer training for three months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Employment status of the participants at nine months follow-up
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Compliance of cognitive computer training
기간: 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.
기간: 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.
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bent Nielsen, Prof.MD, University of Southern Denmark
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 12월 1일
기본 완료 (예상)
2017년 10월 1일
연구 완료 (예상)
2017년 10월 1일
연구 등록 날짜
최초 제출
2016년 6월 6일
QC 기준을 충족하는 최초 제출
2016년 6월 29일
처음 게시됨 (추정)
2016년 7월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 7월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 6월 29일
마지막으로 확인됨
2016년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .