- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01964898
Post Acute Coronary Event Smoking Study (PACES)
Integrated Smoking Cessation and Mood Management for Cardiac Patients
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02903
- The Miriam Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Smoking Cessation: 7 Day Point Prevalence Abstinence
Délai: 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
Délai: 6 months
|
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
Time to Smoking Relapse
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Délai: 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.
|
Baseline to 6 months
|
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Délai: 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
Délai: 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
|
Negative Affect
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrew M Busch, Ph.D, The Miriam Hospital Centers for Behavioral and Preventive Medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Ischémie myocardique
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Syndrome coronarien aigu
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents cholinergiques
- Stimulants ganglionnaires
- Agonistes nicotiniques
- Agonistes cholinergiques
- Nicotine
Autres numéros d'identification d'étude
- 5K23HL107391 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Behavioral Activation (BA)
-
Universidad Complutense de MadridInconnuePerformance athlétiqueEspagne
-
Maastricht University Medical CenterB. Braun/Aesculap SpineComplétéDéplacement du disque intervertébral | DiscectomiePays-Bas
-
BioNTech SEPfizerComplétéCOVID-19 [feminine] | Infection par le SRAS-CoV-2États-Unis
-
Weill Medical College of Cornell UniversityRecrutementDépression périnatale | Anxiété périnataleÉtats-Unis
-
BioNTech SEPfizerRetiré
-
Providence VA Medical CenterComplétéLa dépression | DiabèteÉtats-Unis
-
José Casaña GranellUniversity of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group...ComplétéIncontinence urinaire | Troubles du plancher pelvien | Faiblesse des muscles du plancher pelvien | Incontinence urinaire, StressEspagne
-
Aesculap Implant SystemsComplétéDiscopathie dégénérativeÉtats-Unis
-
University of ExeterDevon Partnership NHS TrustComplétéDépression bipolaireRoyaume-Uni
-
St. Joseph's Healthcare HamiltonComplété