Cardiovascular Diseases Clinical Trial
To study the process of recycling failed smoking cessation attempts and relapses.
BACKGROUND:
Depending on the type of treatment, between 25 percent and 80 percent of smokers fail to
quit with a program, and of those who initially quit, as many as 80 percent may relapse
within a year. Thus, we need to understand more about the consequences of these 'failures'
on subsequent cessation attempts and success and to develop more effective treatment
programs to recycle these smokers into sustained abstinence.
DESIGN NARRATIVE:
The study focused on two subsets of smokers frequently ignored by researchers and
intervention programs: subjects who failed to quit with a cessation program and subjects who
relapsed after achieving abstinence. The primary aim was to develop and evaluate the
efficacy of an intervention tailored to stage of change (still smoking, abstinent, relapsed)
that used extended contact, motivation, and efficacy building strategies to: 1) increase the
percentage of subjects who achieved subsequent abstinence after failing to quit with a core
group treatment; 2) decrease relapse rates; and 3) increase the rate of sustained recycling
(i.e., maintained abstinence) following a relapse. The investigators also tested the extent
to which the effects on abstinence were explained by the mediating variables of motivation
and self- efficacy. Secondary aims included: 1) examining the role of several psychosocial
variables in the maintenance, relapse, and cessation processes; 2) describing and examining
longitudinal changes following smoking cessation; and 3) examining the long-term (beyond two
years) effects of the study's intervention.
The design of the study comprised two conditions: 1) Control Condition (N = 452) and 2)
Enhanced Treatment Condition (N = 452). the two treatment conditions had a common core
seven-week cessation and relapse prevention group program. Following the group program, the
two conditions differed in both format and content of treatment. Subjects in the Control
Condition received seven counselor-initiated phone calls over a three month period. The
content of the phone calls represented the most effective components of the study and varied
depending on whether the subjects were smoking or abstinent. Treatment in the Enhanced
Condition was tailored to three groups of subjects: smokers, abstainers, and relapsers.
Subjects who were smoking at the end of the core program received three more weekly group
meetings followed by three phone calls, and then six monthly calls. The content of their
treatment was based on the factors that the study found most related to failure to quit
(negative affect, low motivation, low efficacy). Subjects who were abstinent at the end of
the core program received seven phone cells over a three month period and then six monthly
calls. The content of their treatment included efficacy and motivation building exercises as
well as the continued contact for six more months than in the Control condition. Follow-up
data were collected every three months for 15 months beyond the core cessation program. The
hypothesis was that the Enhanced Treatment, compared with the Control, would improve rates
of recycling after a failure to quit, decrease relapse rates, and increase sustained
recycling following a relapse.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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