Optimising Cognitive Function in Patients With Chronic Pain
調査の概要
詳細な説明
Rationale for project:
Cognitive difficulties may occur with chronic pain, potentially indicative of compromised functioning in frontal brain regions, which also results in greater difficulty controlling pain, with increased rumination and worry. Discovering a successful method for strengthening these neural systems may improve cognitive skills important for daily life and maximise therapeutic outcomes.
Research questions:
In people experiencing cognitive deficits due to their pain condition:
- Can neurocognitive abilities be improved?
- Can such improvements bring about better daily functioning in general?
- If these training protocols improve cognition, will there also be an effect of pain reduction, i.e., in the extent to which pain interferes with a person's life?
Aim:
The overarching aim of this research is to determine whether cognitive function can be improved via a training protocol in people experiencing cognitive difficulties related to chronic pain.
Design:
This is a randomised controlled trial examining the effects of cognitive training compared with an active control. The investigators aim to enrol 40 participants with chronic pain in the study: 20 training, and 20 active control. This sample size was chosen based on a power analysis with moderate effect size, and is consistent with sample sizes in the existing cognitive training literature, though no similar study has so far been done in a chronic pain population. Both groups will complete their respective study activities 3 times per week, for 45 minutes each time, across 8 weeks. They will be assessed before completing the 8-week period, and again within a few days of completion.
Procedures:
40 participants will be recruited via the Caulfield Pain Management and Research Centre.
After deciding to participate and meeting all inclusion criteria, participants will be invited to attend their first on-site assessment session at Monash University, Clayton. The first assessment session will include an overview of the training program and demonstration of how to do the tasks, or an overview of the active control activities (as applicable). Both assessment sessions will involve detailed assessment of cognition, pain, and mood.
The cognitive training protocol will be run using pre-validated software that delivers brain training "games". The games are designed to be visually interesting and engaging, and are varied so that each session will comprise multiple different games, to avoid boredom. They begin with easy-to-follow instructions and demonstrations, then as the participant progresses, the difficulty is automatically increased in correspondence with their performance, to avoid ceiling or plateau effects. Participants will be assigned a program targeting multiple facets of cognition found to be compromised in chronic pain states, including divided attention, working memory, mentally planning a sequence of items to form a pattern or complete a puzzle, and response inhibition.
This software is accessible via the internet on desktop and laptop computers, or on tablet devices. All training sessions will be completed at home. The researchers will hold a master account, allowing them to log in and monitor participant progress and compliance with the training.
The active control group will be provided with a variety of videos to watch, the content of which will be in the style of documentaries on general interest topics such as nature, travel, culture, and history. These are also visually stimulating and engaging, but involve no increment in difficulty. They may provide distraction from pain and may be relaxing.
Throughout the protocol, the researchers will have weekly contact with participants by phone or video call. Keeping regular contact in this way will maintain engagement with the research team, help boost motivation and allow participants to express any issues they may be having with the protocol.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Melbourne、オーストラリア
- Monash University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Chronic pain condition
- Access to computer and internet
Exclusion Criteria:
- High dosages of opioid or benzodiazepine medication
- Currently receiving active allied health treatment
- Intellectual disability, traumatic brain injury, dementia, or other neurological disorders
研究計画
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Computerised cognitive training
The cognitive training protocol will be run using pre-validated software, HappyNeuronPro, that delivers cognitive training games.
The games are designed to be visually interesting and engaging, and are varied so that each session will comprise multiple different games, to avoid boredom.
They begin with easy-to-follow instructions and demonstrations, then as the participant progresses, the difficulty is automatically increased in correspondence with their performance, to avoid ceiling or plateau effects.
Participants will be assigned a program targeting multiple facets of cognition found to be compromised in chronic pain states, including divided attention, working memory, mentally planning a sequence of items to form a pattern or complete a puzzle, and response inhibition.
|
|
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アクティブコンパレータ:Video watching
This group will be provided with a variety of videos to watch, the content of which will be in the style of documentaries on general interest topics such as nature, travel, culture, and history.
Each video is followed by multiple-choice questions that participants will answer, to ensure attention was engaged.
The videos are visually stimulating and engaging, but involve no increment in difficulty or requirement to improve skills.
They may provide some distraction from pain and may be relaxing, interesting and informative.
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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 |
|---|---|---|
|
Objective cognitive functioning
時間枠:8 weeks
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Composite of neuropsychological test scores
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8 weeks
|
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Subjective cognitive functioning
時間枠:8 weeks
|
Self-report measures of cognition
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8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain
時間枠:8 weeks
|
Pain intensity and interference from the Brief Pain Inventory
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8 weeks
|
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Mood and coping
時間枠:8 weeks
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Self-report measures of anxiety, depression, pain catastrophizing and pain self-efficacy
|
8 weeks
|
|
Heart rate variability
時間枠:8 weeks
|
Electrophysiological measure
|
8 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Melita Giummarra, PhD、Monash University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
慢性の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Computerised cognitive trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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University of Texas at Austinまだ募集していません
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Douglas Mental Health University Institute積極的、募集していない
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了