The Mindfulness Intervention as Myocardial Infarction Rehabilitation Additive (MIMIRA) Study (MIMIRA)
調査の概要
詳細な説明
Depressive symptomatology in patients with coronary artery disease (CAD) has prognostic importance. Yet, psychological interventions in clinical practice are scarce. Here, we explored the feasibility and acceptability of mindfulness-based stress reduction (MBSR) in patients with depressive symptoms after a recent coronary event. A second aim was to investigate psychological risk factors and resources among participants.
To address the research questions, depressive symptoms were first measured in a reference population, at 1 and 12 months after a coronary event (myocardial infarction or unstable angina pectoris), and a cut-off for elevated depressive symptoms were obtained from the median in this group. Thereafter, similar CAD patients with elevated depressive symptoms (above median in the reference group), from the same outpatient clinic, were consecutively invited to an 8-week MBSR program. Serious physical or psychiatric illness that would be an obstacle to participation were exclusion criteria.
Patients who completed the MBSR-course were asked to evaluate its various facets, and completion rate and attendance were feasibility outcomes. Psychological variables were measured before, after the course as well as 12 months later.
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
-
-
-
Linköping、スウェーデン、581 83
- Linköping 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:
- Recent (within 12 month) first time coronary artery event; defined as a diagnosis of myocardial infarction or unstable angina pectoris addressed with either percutaneous coronary intervention (PCI) or coronary artery by-pass graft surgery (CABG).
- Depressive symptoms above a score of 8 on the questionnaire centre for epidemiological studies depression scale (CES-D).
- Interest for participation in MBSR.
Exclusion Criteria:
- Major depression or other serious psychiatric illness (such as psychosis or ongoing life crisis).
- Severe comorbidities, such as cancer, severe cognitive impairment and alcohol or drug abuse.
- Practical hindrances for participation in MBSR.
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：MBSR participation
Participation in the 8 week Mindfulness Based Stress Reduction (MBSR) course.
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An 8-week course in mindfulness meditation, yoga training and weekly group support in the form of weekly 2,5 hour meetings at the hospital.
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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 |
|---|---|---|
|
Feasibility
時間枠：Immediately after the 8-week intervention.
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Patient evaluation questionnaire
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Immediately after the 8-week intervention.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depressive Symptoms
時間枠：Before, immediately after and 12 months post intervention.
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Centre for Epidemiological Studies Scale Depression (CES-D) questionnaire (Radloff)
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Before, immediately after and 12 months post intervention.
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Anxiety
時間枠：Before, immediately after and 12 months post intervention.
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Generalized Anxiety Disorder Scale - 7 (GAD-7) questionnaire (Spitzer)
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Before, immediately after and 12 months post intervention.
|
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Mindfulness
時間枠：Before, immediately after and 12 months post intervention.
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Five Facets of Mindfulness Questionnaire (FFMQ) (Baer)
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Before, immediately after and 12 months post intervention.
|
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Acceptance
時間枠：Before, immediately after and 12 months post intervention.
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Acceptance and Action Questionnaire II (AAQII) (Block)
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Before, immediately after and 12 months post intervention.
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Mastery
時間枠：Before, immediately after and 12 months post intervention.
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Mastery questionnaire (Pearlin & Shooler)
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Before, immediately after and 12 months post intervention.
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Self-esteem
時間枠：Before, immediately after and 12 months post intervention.
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Self-esteem questionnaire (Rosenberg)
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Before, immediately after and 12 months post intervention.
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Patients experiences of mindfulness training
時間枠：Continuously during the 8 week course.
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Written journal entries (linguistic content)
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Continuously during the 8 week course.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lena LJ Jonasson, M.D. Ph.D.、Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University
出版物と役立つリンク
一般刊行物
- Lundgren O, Garvin P, Nilsson L, Tornerefelt V, Andersson G, Kristenson M, Jonasson L. Mindfulness-Based Stress Reduction for Coronary Artery Disease Patients: Potential Improvements in Mastery and Depressive Symptoms. J Clin Psychol Med Settings. 2022 Sep;29(3):489-497. doi: 10.1007/s10880-021-09822-z. Epub 2021 Sep 28.
- Lundgren O, Garvin P, Kristenson M, Jonasson L, Thylen I. A journey through chaos and calmness: experiences of mindfulness training in patients with depressive symptoms after a recent coronary event - a qualitative diary content analysis. BMC Psychol. 2018 Sep 13;6(1):46. doi: 10.1186/s40359-018-0252-1.
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 2013/17/31
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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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