N/A
Completed N=64
Post Acute Coronary Event Smoking Study
Source: ClinicalTrials.gov NCT01964898 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Smoking Cessation: 7 Day Point Prevalence Abstinence — 0.46; 0.44 proportion of participants
Summary
Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation: 7 Day Point Prevalence Abstinence |
0.46; 0.44 | — |
| PRIMARY Continuous Abstinence From Smoking Since Discharge |
0.38; 0.34 | — |
| PRIMARY Time to Smoking Relapse |
71.2; 47.4 | — |
| PRIMARY Time to Smoking Lapse |
62.4; 31.8 | — |
| SECONDARY Depression: 9 Item Patient Health Questionnaire (PHQ-9) |
6.33; 6.98; 3.34; 6.08 | — |
| SECONDARY Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) |
10.36; 11.72; 5.57; 6.93 | — |
| SECONDARY Positive Affect |
13.47; 14.56; 16.85; 15.79 | — |
| SECONDARY Negative Affect |
9.63; 7.62; 7.41; 8.14 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01964898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.