NCT01964898

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 12, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

October 15, 2013

Results QC Date

October 5, 2016

Last Update Submit

January 10, 2017

Conditions

Smoking CessationAcute Coronary Syndrome

Keywords

SmokingMood ManagementDepressionBehavioral ActivationAcute Coronary SyndromeMyocardial Infarction

Outcome Measures

Primary Outcomes (4)

  • Smoking Cessation: 7 Day Point Prevalence Abstinence

    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

    Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.

    6 months

  • Time to Smoking Relapse

    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

    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

Secondary Outcomes (4)

  • Depression: 9 Item Patient Health Questionnaire (PHQ-9)

    Baseline to 6 months

  • Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)

    Baseline to 6 months

  • Positive Affect

    Baseline to 6 months

  • Negative Affect

    Baseline to 6 months

Study Arms (2)

BA for cardiac patients who smoke

EXPERIMENTAL

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.

Behavioral: Behavioral Activation (BA)Behavioral: Standard Smoking Cessation CounselingDrug: Nicotine patch

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Smoking Cessation CounselingDrug: Nicotine patchOther: Printed Self-help materials for Smoking Cessation

Interventions

Behavioral Activation (BA)BEHAVIORAL

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.

BA for cardiac patients who smoke
Standard Smoking Cessation CounselingBEHAVIORAL

1 hour of in hospital counseling based on clinical guidelines

BA for cardiac patients who smokeStandard Care
Nicotine patchDRUG

An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

BA for cardiac patients who smokeStandard Care
Printed Self-help materials for Smoking CessationOTHER
Standard Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.

    PMID: 28415979DERIVED

MeSH Terms

Conditions

Smoking CessationAcute Coronary SyndromeSmokingDepressionMyocardial Infarction

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavioral SymptomsInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Andrew Busch PhD
Organization
The Miriam Hospital
andrew_busch@brown.edu
4017938189

Study Officials

  • Andrew M Busch, Ph.D

    The Miriam Hospital Centers for Behavioral and Preventive Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 17, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 12, 2017

Results First Posted

January 12, 2017

Record last verified: 2017-01

Locations

US(1)