Dynamic Learning in Depression
2020年6月15日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX3 7JX
- Dept of Psychiatry, University of Oxford
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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.
|
Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
|
安慰剂比较: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
|
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
大体时间:change between baseline and week 6
|
Standard questionnaire measure of depressive symptoms
|
change between baseline and week 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
大体时间:change between baseline and week 2
|
standard questionnaire measure of depressive symptoms
|
change between baseline and week 2
|
Montgomery Asberg Depression Rating Scale
大体时间:change from baseline to week 2 and 6
|
Standard clinical rating scale for depression
|
change from baseline to week 2 and 6
|
Learning parameters from information bias assessment task
大体时间:baseline to weeks 2 and 6
|
Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
|
baseline to weeks 2 and 6
|
Salivary cortisol concentration
大体时间:baseline to weeks 2 and 6
|
Samples collected on waking
|
baseline to weeks 2 and 6
|
Learning parameters derived from pupillometry data
大体时间:baseline to weeks 2 and 6
|
Parameters are derived from regression of pupil size data collected during the information bias assessment task
|
baseline to weeks 2 and 6
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Speilberger State and Trait Anxiety Inventory
大体时间:Baseline to weeks 2 and 6
|
standard questionnaire measure of state and trait anxiety
|
Baseline to weeks 2 and 6
|
Depressive Attributes Questionnaire
大体时间:baseline to weeks 2 and 6
|
Questionnaire assessing attribution bias in depression
|
baseline to weeks 2 and 6
|
Rumination Response Scale
大体时间:baseline to weeks 2 and 6
|
Questionnaire assessing tendency to ruminate
|
baseline to weeks 2 and 6
|
Snaith-Hamilton Pleasures Scale
大体时间:Baseline to weeks 2 and 6
|
Questionnaire assessing anhedonia
|
Baseline to weeks 2 and 6
|
Accuracy and reaction time during computerised cognitive tasks
大体时间:baseline to weeks 2 and 6
|
Scores are derived from computer based tasks assessing emotional perception and learning
|
baseline to weeks 2 and 6
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michael Browning, MB.BS、University of Oxford
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年11月1日
初级完成 (实际的)
2020年6月3日
研究完成 (实际的)
2020年6月3日
研究注册日期
首次提交
2016年9月22日
首先提交符合 QC 标准的
2016年9月22日
首次发布 (估计)
2016年9月26日
研究记录更新
最后更新发布 (实际的)
2020年6月16日
上次提交的符合 QC 标准的更新
2020年6月15日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.