Mind-Body Interventions in Coronary Artery Disease (MBI-CAD)
Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease
This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease.
A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only.
Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period.
The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.
調査の概要
詳細な説明
This study is a prospective, randomized controlled clinical trial designed to evaluate the effects of a structured mind-body intervention on psychological outcomes in patients with stable coronary artery disease.
Eligible participants will be recruited from Ufuk University Department of Cardiology and randomly assigned to either an intervention group or a control group using a simple randomization method. The intervention group will receive eight individualized sessions of progressive muscle relaxation and guided imagery over a four-week period in addition to standard medical care. Each session will last approximately 45-60 minutes and will be conducted in a controlled clinical environment by trained researchers. The control group will continue receiving standard medical care without any additional psychological or behavioral intervention.
Outcomes will be assessed at baseline and post-intervention using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory. The primary outcome is change in perceived stress levels. Secondary outcomes include changes in anxiety, depression, and coping strategies.
Data will be analyzed using repeated measures ANOVA to examine the interaction effects between group (intervention vs control) and time (baseline vs post-intervention). Effect sizes will be reported, and statistical significance will be set at p < 0.05.
The study does not involve any investigational drugs, biologics, or medical devices, and poses minimal risk to participants.
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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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06000
- Ufuk University Faculty of Medicine, Department of Cardiology
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosed with stable coronary artery disease
- Aged between 18 and 65 years
- Able to read and understand Turkish
- Able to complete study questionnaires and assessments
- Willing to provide written informed consent
Exclusion Criteria:
- History of acute coronary syndrome within the last 3 months
- Presence of a diagnosed severe psychiatric disorder
- Cognitive impairment or communication difficulties that may interfere with study participation
- Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs
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 |
|---|---|
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実験的：Intervention Group
Participants in this arm will receive an eight-session individualized mind-body intervention consisting of progressive muscle relaxation and guided imagery in addition to standard medical care.
Sessions will be delivered twice weekly over four weeks in a clinical setting by trained researchers.
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A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
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介入なし：Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.
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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 in Perceived Stress Scale (PSS) Score
時間枠：Baseline and 4 weeks
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The primary outcome is the change in perceived stress levels measured by the Perceived Stress Scale (PSS) between baseline and the end of the 4-week intervention period.Scores range from 0 to 16, with higher scores indicating greater perceived stress.
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Baseline and 4 weeks
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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 |
|---|---|---|
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Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
時間枠：Baseline and 4 weeks
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Change in anxiety measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS).
Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Outcome will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
時間枠：Baseline and 4 weeks
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Change in depression measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS).
Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Outcome will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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Change in COPE Coping Strategies Scale Scores
時間枠：Baseline and 4 weeks
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Change in coping strategies measured by the COPE Inventory.
The instrument contains 15 coping subscales, each scored from 4 to 16, with higher scores indicating greater use of the respective coping strategy.
Outcomes will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Şeyda Candeniz, PhD、Ankara University
出版物と役立つリンク
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
追加の関連 MeSH 用語
その他の研究ID番号
- UFUK-SAGBIL-BADEK-2026/05
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
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