A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses
An Exploratory Randomised Pilot Trial Examining the Potential Effectiveness of an Online Mindfulness Based Stress Reduction Programme for Informal Caregivers of People With Chronic Illnesses.
調査の概要
詳細な説明
The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.
A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.
Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.
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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Dublin、アイルランド、dublin 2
- Trinity College Dublin
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Dublin、アイルランド
- Trinity College Dubliln
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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:
- Be 18 years of age and over
- Provide unpaid care to an adult or child with a chronic illness
- Not suffer from a severe mental illness
- Be ready to commit to the course at this point in their lives.
Exclusion Criteria:
- Caregivers who are under the age of 18 years.
- Caregivers who have a serious mental illness, such as severe anxiety/depression.
- Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
- Caregivers with an active or recent physical addiction to alcohol or drugs.
- Caregivers who are already engaged in similar research.
- Caregivers who have already participated in mindfulness based stress reduction (MBSR) or MBCT training.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：普段のお手入れ
介入なし
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実験的：Mindfulness based Stress Reduction
This is an active intervention The MBSR programme is delivered online with weekly telephone and email contact from a trained mindfulness teacher.
Participants are encouraged to practice mindfulness exercises and homework between sessions.
The online programme was developed be a trained mindfulness teacher.
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Mindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited.
The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way.
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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 |
|---|---|---|
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Change over time in Calgary Symptoms of Stress Inventory (C-SOSI)
時間枠：up to 2 weeks and 6 months post-intervention
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Response to stressful situations
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up to 2 weeks and 6 months post-intervention
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Change over time in Perceived Stress Scale
時間枠：up to 2 weeks and 6 months post-intervention
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perceived stress
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up to 2 weeks and 6 months post-intervention
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Change over time in Cognitive and Affective Mindfulness Scale Revised (CAMS-R)
時間枠：up to 2 weeks and 6 months post-intervention
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Mindfulness
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up to 2 weeks and 6 months post-intervention
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Change over time in The Adult Carer Quality of Life Questionnaire
時間枠：up to 2 weeks and 6 months post-intervention
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Quality of Life
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up to 2 weeks and 6 months post-intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Caregiver MBCT Programme Evaluation Form
時間枠：up to 2 weeks post-intervention
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programme evaluation
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up to 2 weeks post-intervention
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協力者と研究者
捜査官
- 主任研究者：Margarita Corry、University of Dublin, Trinity College
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。
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