- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02913898
Dynamic Learning in Depression
2020년 6월 15일 업데이트: University of Oxford
This study will assess learning bias (the tendency to learn more from negative relative to positive outcomes) at baseline in 3 groups of participants (currently depressed, previously depressed and never depressed).
It will then try to modify this bias using a simple computerised training task completed at home daily for 2 weeks.
Outcome measures include symptoms of depression, cognitive measures (i.e.
accuracy and reaction time during completion of tasks), pupillometry measures and salivary cortisol.
연구 개요
상세 설명
Depressed patients tend to focus on negative, at the expense of positive, events.
This bias of attention is thought to be one factor which causes some people to be at higher risk of developing depression.
One reason depressed people might pay more attention to negative events is that they think those events are more useful to them when they learn about the future.
In this study the investigators will compare the learning styles (i.e.
whether participants focus more on negative or positive information when learning about the future), cognitive biases and salivary cortisol levels (the levels of the hormone cortisol can be measured in the saliva and is known to be raised in those at risk of depression) of currently depressed (N=40), previously depressed (N=40) and never depressed (N=40) participants.
The study will then randomly assign participants to complete one of two version of a learning task daily over two weeks.
One version of the task will be designed to encourage an optimistic learning style, whereas the other will encourage neither an optimistic nor pessimistic learning style.
The study will then retest participants' learning styles, cognitive biases, salivary cortisol and mood (using questionnaire measures) after completion of the task and again after 1 month.
Study activities for participants will be: Screening visit (1 hours), baseline test visit (2 hours), task completion at home (10 mins per day for 2 weeks), test visit 2 (2 hours, completed 2 weeks after baseline visit) and test visit 3 (2 hours, completed 1 month after test visit 2).
Participants will be asked to collect saliva samples, to measure cortisol, immediately after they wake up on the 3 testing days.
Note that testing sessions involve pupillometry (measurement of area of pupil of the eye).
This is done using a specialised camera pointed at the eye and is not invasive.
연구 유형
중재적
등록 (실제)
120
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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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 7JX
- Dept of Psychiatry, University of Oxford
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 to 60 years.
- Fluent in English.
- Not currently taking any psychoactive medications (except hormone contraceptives).
- Currently meets SCID (Structured Clinical Interview for Diagnosis:DSMV) criteria for MDD--Major Depressive Disorder-- (currently depressed group only).
- Meets SCID criteria for 2 or more previous episodes of MDD, has been in remission for at least 3 months (previously depressed group only).
- No previous or current axis I diagnosis (control group only).
Exclusion Criteria:
- Previous or current diagnosis of bipolar disorder or psychotic illness.
- Previous or current anxiety disorder (control group only, anxiety disorder is permitted in current and previously depressed group as long as primary diagnosis of MDD (current or previous) is present).
- Significant suicidal ideation.
- Use of drug of abuse within the last 3 months.
- Receiving treatment (either pharmacological or psychological) for psychiatric condition.
- Medical or surgical treatment which prevents dilation/constriction of pupil.
- Prior experience of the tasks used in the study.
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: IBLT (information bias learning task)
Computerised task in which most information is provided by positive outcomes.
Completed for 10 mins per day every day for 2 weeks.
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Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
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위약 비교기: IBLT control
Computerised task in which information is provided by both positive and negative outcomes.
Completed 10 mins per day every day for 2 weeks
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A control version of the IBLT task-- a computer based task in which both positive and negative information is useful when learning how to complete it
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quick Inventory of Depressive Symptoms (self report, 16 item)
기간: change between baseline and week 6
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Standard questionnaire measure of depressive symptoms
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change between baseline and week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quick Inventory of Depressive Symptoms (self report, 16 item)
기간: change between baseline and week 2
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standard questionnaire measure of depressive symptoms
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change between baseline and week 2
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Montgomery Asberg Depression Rating Scale
기간: change from baseline to week 2 and 6
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Standard clinical rating scale for depression
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change from baseline to week 2 and 6
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Learning parameters from information bias assessment task
기간: baseline to weeks 2 and 6
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Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
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baseline to weeks 2 and 6
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Salivary cortisol concentration
기간: baseline to weeks 2 and 6
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Samples collected on waking
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baseline to weeks 2 and 6
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Learning parameters derived from pupillometry data
기간: baseline to weeks 2 and 6
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Parameters are derived from regression of pupil size data collected during the information bias assessment task
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baseline to weeks 2 and 6
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Speilberger State and Trait Anxiety Inventory
기간: Baseline to weeks 2 and 6
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standard questionnaire measure of state and trait anxiety
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Baseline to weeks 2 and 6
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Depressive Attributes Questionnaire
기간: baseline to weeks 2 and 6
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Questionnaire assessing attribution bias in depression
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baseline to weeks 2 and 6
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Rumination Response Scale
기간: baseline to weeks 2 and 6
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Questionnaire assessing tendency to ruminate
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baseline to weeks 2 and 6
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Snaith-Hamilton Pleasures Scale
기간: Baseline to weeks 2 and 6
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Questionnaire assessing anhedonia
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Baseline to weeks 2 and 6
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Accuracy and reaction time during computerised cognitive tasks
기간: baseline to weeks 2 and 6
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Scores are derived from computer based tasks assessing emotional perception and learning
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baseline to weeks 2 and 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael Browning, MB.BS, University of Oxford
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 (실제)
2016년 11월 1일
기본 완료 (실제)
2020년 6월 3일
연구 완료 (실제)
2020년 6월 3일
연구 등록 날짜
최초 제출
2016년 9월 22일
QC 기준을 충족하는 최초 제출
2016년 9월 22일
처음 게시됨 (추정)
2016년 9월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 15일
마지막으로 확인됨
2019년 4월 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. .