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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
120
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
-
-
Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 7JX
- Dept of Psychiatry, University of Oxford
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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
18年～60年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
|
|
プラセボコンパレーター：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
|
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 |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
時間枠：change between baseline and week 6
|
Standard questionnaire measure of depressive symptoms
|
change between baseline and week 6
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
時間枠：change between baseline and week 2
|
standard questionnaire measure of depressive symptoms
|
change between baseline and week 2
|
|
Montgomery Asberg Depression Rating Scale
時間枠：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
時間枠：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
時間枠：baseline to weeks 2 and 6
|
Samples collected on waking
|
baseline to weeks 2 and 6
|
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Learning parameters derived from pupillometry data
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speilberger State and Trait Anxiety Inventory
時間枠：Baseline to weeks 2 and 6
|
standard questionnaire measure of state and trait anxiety
|
Baseline to weeks 2 and 6
|
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Depressive Attributes Questionnaire
時間枠：baseline to weeks 2 and 6
|
Questionnaire assessing attribution bias in depression
|
baseline to weeks 2 and 6
|
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Rumination Response Scale
時間枠：baseline to weeks 2 and 6
|
Questionnaire assessing tendency to ruminate
|
baseline to weeks 2 and 6
|
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Snaith-Hamilton Pleasures Scale
時間枠：Baseline to weeks 2 and 6
|
Questionnaire assessing anhedonia
|
Baseline to weeks 2 and 6
|
|
Accuracy and reaction time during computerised cognitive tasks
時間枠：baseline to weeks 2 and 6
|
Scores are derived from computer based tasks assessing emotional perception and learning
|
baseline to weeks 2 and 6
|
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
捜査官
- 主任研究者：Michael Browning, MB.BS、University of Oxford
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 (実際)
2016年11月1日
一次修了 (実際)
2020年6月3日
研究の完了 (実際)
2020年6月3日
試験登録日
最初に提出
2016年9月22日
QC基準を満たした最初の提出物
2016年9月22日
最初の投稿 (見積もり)
2016年9月26日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月16日
QC基準を満たした最後の更新が送信されました
2020年6月15日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。