Post Acute Coronary Event Smoking Study (PACES)
Integrated Smoking Cessation and Mood Management for Cardiac Patients
調査の概要
状態
詳細な説明
The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population.
Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.
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
-
-
Rhode Island
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Providence、Rhode Island、アメリカ、02903
- The Miriam Hospital
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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:
- ACS diagnosis documented in medical record
- smoked 3 or more cigarettes per day before being hospitalized
- between the ages of 18-75
- fluent in English
- regular access to a telephone
- lives in the Providence, RI area
- willing to "strongly consider" an attempt to quit smoking at discharge
Exclusion criteria:
- limited mental competency (i.e., Mini-Mental Status exam < 20)
- presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period
- currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge
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：BA for cardiac patients who smoke
Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS).
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital.
BA sessions will occur over the 12 weeks after hospital discharge.
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management.
BA sessions will occur over the 12 weeks after hospital discharge.
1 hour of in hospital counseling based on clinical guidelines
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
|
アクティブコンパレータ：Standard Care
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge.
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
1 hour of in hospital counseling based on clinical guidelines
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
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 |
|---|---|---|
|
Smoking Cessation: 7 Day Point Prevalence Abstinence
時間枠：6 months
|
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
|
Continuous Abstinence From Smoking Since Discharge
時間枠：6 months
|
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
|
Time to Smoking Relapse
時間枠：6 months
|
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
|
Time to Smoking Lapse
時間枠：6 months
|
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
時間枠：Baseline to 6 months
|
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
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Baseline to 6 months
|
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Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
時間枠：Baseline to 6 months
|
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
|
Baseline to 6 months
|
|
Positive Affect
時間枠：Baseline to 6 months
|
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS).
The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
|
Baseline to 6 months
|
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Negative Affect
時間枠：Baseline to 6 months
|
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS).
The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
|
Baseline to 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Andrew M Busch, Ph.D、The Miriam Hospital Centers for Behavioral and Preventive Medicine
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
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 (見積もり)
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
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