The smoker's health project: a self-determination theory intervention to facilitate maintenance of tobacco abstinence.

Abstract

A previous randomized clinical trial based on self-determination theory (SDT) and consistent with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence demonstrated that an intensive intervention could change autonomous self-regulation and perceived competence, which in part facilitated long-term tobacco abstinence. The current article describes a pragmatic comparative effectiveness trial of three SDT-based intensive tobacco-dependence interventions. Eligible participants are randomized to one of the three treatment conditions designed to facilitate long-term maintenance of tobacco abstinence, namely, Community Care (CC), which includes the 6 month SDT-based intervention previously shown to promote autonomous self-regulation, perceived competence, medication use, and tobacco abstinence; Extended Need Support (ENS), which extends the 6 month SDT-based intervention to 12 months and trains an important other to provide support for smokers' basic psychological needs; and Harm Reduction (HR), which provides extended need support and recommends medication use for participants who do not want to stop smoking completely within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is 12 month prolonged abstinence from tobacco, which is assessed one year following termination of treatment (two years post-randomization). Secondary outcomes include 7- and 30 day point prevalence tobacco abstinence, number of days using smoking-cessation medication, change in autonomous self-regulation and perceived competence, and perceived need support from important others.

Full text

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The Smoker's Health Project: A self-determination theory intervention to
facilitate maintenance of tobacco abstinence☆
Geoffrey C. Williamsa,⁎, Heather Patrickb, Christopher P. Niemiecc, Richard M. Ryanc,
Edward L. Decic, Holly McGregor Lavignea
aUniversity of Rochester, Healthy Living Center, Center for Community Health, Rochester, NY 14607, USA
bNational Cancer Institute, Division of Cancer Control and Population Sciences, Bethesda, MD 20892, USA
cUniversity of Rochester, Department of Clinical and Social Sciences in Psychology, Rochester, NY 14627, USA
a r t i c l e i n f oa b s t r a c t
Article history:
Received 8 December 2010
Accepted 1 March 2011
Available online 5 March 2011
A previous randomized clinical trial based on self-determination theory (SDT) and consistent
with the Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence
demonstrated that an intensive intervention could change autonomous self-regulation and
perceived competence, which in part facilitated long-term tobacco abstinence. The current
article describes a pragmatic comparative effectiveness trial of three SDT-based intensive
tobacco-dependence interventions. Eligible participants are randomized to one of the three
treatment conditions designed to facilitate long-term maintenance of tobacco abstinence,
namely, Community Care (CC), which includes the 6 month SDT-based intervention previously
shown to promote autonomous self-regulation, perceived competence, medication use, and
tobacco abstinence; Extended Need Support (ENS), which extends the 6 month SDT-based
intervention to 12 months and trains an important other to provide support for smokers' basic
psychological needs; and Harm Reduction (HR), which provides extended need support and
recommends medication use for participants who do not want to stop smoking completely
within 30 days but who are willing to reduce their cigarette use by half. The primary outcome is
12 month prolonged abstinence from tobacco, which is assessed one year following
termination of treatment (two years post-randomization). Secondary outcomes include 7-
and 30 day point prevalence tobacco abstinence, number of days using smoking-cessation
medication, change in autonomous self-regulation and perceived competence, and perceived
need support from important others.
© 2011 Elsevier Inc. All rights reserved.
Keywords:
Autonomy
Perceived competence
Pragmatic comparative effectiveness trial
Self-determination theory
Tobacco abstinence
1. Introduction
In 2003, the National Institutes of Health funded 21 studies
to examine long-term maintenance of health-behavior change,
via the Health Maintenance Consortium. Herein, we describe
interventions based on self-determination theory (SDT) [1–4]
and designed to facilitate long-term tobacco abstinence, which
willbeexaminedinapragmatic comparativeeffectivenesstrial
called the Smoker's Health Project (SHP).
1.1. Importance of developing effective interventions for
maintenance of tobacco abstinence
Despite the many behavioral, pharmacological, and pub-
lic-policy efforts to promote smoking cessation, tobacco use
remains the leading cause of preventable death in the US [5].
Underscoring the importance of tobacco abstinence, people
who stop smoking live longer and have better quality of life
than those who continue to smoke [6,7]. The Public Health
Service (PHS) Guideline for Treating Tobacco Use and
Contemporary Clinical Trials 32 (2011) 535–543
☆ Trial registration: ClinicalTrials.gov number NCT00178685.
⁎ Corresponding author at: Healthy Living Center, Center for Community
Health, University of Rochester, 46 Prince Street Suite 3001, Rochester, NY
14607, USA. Tel.: +1 585 530 2050; fax: +1 585 530 2398.
E-mail address: Geoffrey_Williams@URMC.Rochester.edu (G.C. Williams).
1551-7144/$ – see front matter © 2011 Elsevier Inc. All rights reserved.
doi:10.1016/j.cct.2011.03.002
Contents lists available at ScienceDirect
Contemporary Clinical Trials
journal homepage: www.elsevier.com/locate/conclintrial

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Dependence recommends that intensive treatment include at
least four contacts of more than 10 min each, with total
contact time exceeding 30 min; provision of medical advice
about the health risks of smoking; a description of the health
benefits of cessation and available pharmacotherapy; and
delivery of additional counseling [8,9]. Intensive interven-
tions have been shown to enhance tobacco abstinence and
improve health, are cost effective relative to other standard
medical treatments, and provide a mortality benefit to those
who receive them [8,10–12]. Nonetheless, most people who
stop smoking relapse within one year following termination
of treatment, thus highlighting the importance of under-
standing the factors involved in maintenance of tobacco
abstinence [8].
Most theories of health behavior operationalize mainte-
nance as sustained change over time, although such change is
often measured while the intervention or some other schedule
of reinforcement remains operative. With its applications to
health behavior, SDT speaks to the issue of maintenance and
specifies that true maintenance occurs only after the interven-
tion has ended completely. Most theories fail to address
mechanisms through which maintenance occurs [13]. In
contrast, SDT proposes that both autonomous self-regulation
(ASR)andperceivedcompetence(PC)facilitatemaintenanceof
health-behavior change [14], as maintenance is more likely to
occur when people feel volitional to integrate new behaviors
(e.g.,notusingtobaccotocopewithstress)andusemedication
to relieve withdrawal symptoms and/or lower risk directly.
Before describing the SHP interventions in detail, we provide a
briefoverviewofSDTandhowitguidedthedevelopmentofour
previous randomized clinical trial for smokers [15,16], which
formed a foundation for the current pragmatic comparative
effectiveness trial.
1.2. Self-determination theory and its applications to
health behavior
SDT is a macro-theory of human motivation, emotion, and
personality in social contexts. With its organismic perspective,
SDT posits a natural tendency toward psychological growth,
physical health, and social wellness that is supported by
satisfaction of the basic psychological needs for autonomy,
competence,andrelatedness.Autonomyreferstotheexperience
that behavior is volitional and reflectively endorsed, and is
measured on the treatment self-regulation questionnaire. SDT is
the only empirically derived theory of motivation in which
autonomy is a central focus, and much research from SDT has
examined its correlates in the health-care domain [14]. Compe-
tence refers to the experience of feeling able to achieve a desired
outcome (e.g., to stop smoking). Relatedness refers to the
experience of genuine care and concern from, and trust in,
important others (e.g., health-care practitioners, spouses,
friends).
In a previous trial, we designed and tested an intensive
tobacco-dependenceintervention based onSDTand consistent
with the PHS Guideline that was shown to predict tobacco
abstinence at 6-, 18-, and 30 months post-randomization, as
mediated by change in ASR, PC, and aspirations for physical
health [15–19]. The SHP will compare two augmented SDT-
based interventions intended to facilitate long-term tobacco
abstinence to a standard intervention previously shown to be
superior to community care. We reasoned that the salubrious
effects of our previous trial might be augmented by extending
the duration of the intervention to provide a longer period of
need support, by teaching important others to support
smokers' basic psychological needs, and by recommending
medication use for participants who do not want to stop
smoking completely within 30 days but who are willing to
reduce their cigarette use by half.
1.3. Importance of internalization for maintenance of health-
behavior change
According to SDT, maintenance of a new health behavior
requires that people endorse the value of, and develop the
requisite skills for, change [14]. Internalization refers to the
natural, active process whereby a behavior that was initially
prompted by external sources is regulated with an experience of
autonomy and an accompanying sense of competence [20].
However,theprocessofinternalizationcanfunctionmoreorless
effectively and thus behavioral regulations vary in the extent to
whichtheyareself-determined[21].Peopleperceivethemselves
to be autonomous when their behavior is experienced with a
senseofvolitionandchoice,whereaspeopleperceivethemselves
to be controlled when they experience pressure or coercion to
think, feel, or behave in certain ways. For example, people who
smokearesaidtobeautonomouslyself-regulatediftheyattempt
to stop smoking because it is personally important to them
(identifiedregulation)orcongruentwithdeeplyheldvaluesand
aspirations (integrated regulation). In contrast, people who
smoke are said to be controlled if they attempt to stop because
their health-care practitioner or spouse pressures them to do so
(external regulation) or because they pressure themselves to do
so through guilt or shame (introjected regulation).
The process of internalization is supported by satisfaction
of the basic psychological needs for autonomy, competence,
and relatedness. Health-care practitioners and important
others can support smokers' basic psychological needs by
following the guidelines listed in Table 1, which are
consistent with SDT and the PHS Guideline. Guided by the
SDT model of health-behavior change, Fig. 1 depicts the path
model that will be tested in this trial. Randomized clinical
trials in the domains of physical activity, nutrition, weight
loss, and dental hygiene have shown that social–contextual
factors that support need satisfaction promote internalization
of ASR, PC, aspirationsfor physicalhealth,and maintenance of
health-behavior change [14,19,22–25].
2. Overview of the Smoker's Health Project (SHP)
2.1. Research objectives
The first goal of the SHP is to determine whether
extending the duration of the intervention from six to
12 months would enhance ASR, PC, medication use, and
maintenance of tobacco abstinence. The second goal is to
examine whether important others can learn to support
smokers' basic psychological needs and thereby facilitate
long-term tobacco abstinence. In our previous trial that
intervened on multiple cardiovascular risk factors, autonomy
support from important others enhanced ASR, PC, and
tobacco abstinence, and reduced percent calories from fat
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among those with high cholesterol, but no intervention has
been shown to increase need support from important others
[26]. The third goal is to determine whether recommending
medication use for participants who do not want to stop
smoking completely within 30 days but who are willing to
reduce their cigarette use by half would enhance ASR, PC, and
tobacco abstinence. Studies have shown that offering med-
ications to those who reduce their cigarette use by half may
facilitate tobacco abstinence [9], but research is needed to
determine whether such a recommendation would enhance
ASR and PC. The fourth goal is to provide additional support
for the PHS Guideline, as clinical recommendations based on
systematic literature reviews, meta-analyses, and expert
panel discussions require empirical support, but few such
guidelines are actually tested in effectiveness or pragmatic
trials. The fifth goal is to support autonomy, which along with
enhancing well-being and reducing social injustice has been
elevated to the highest level of biomedical ethics and medical
professionalism [27–29]. Because this trial measures ASR for
tobacco abstinence and medication use, its findings will
contribute to a growing literature on interventions designed
to support autonomy as a clinical goal, in and of itself. Overall,
the SHP is designed to examine the effectiveness of two
augmented SDT-based interventions – both place greater
emphasisonmedication useandneed support,andoneuses a
smoking-reduction approach – relative to our previously
validated treatment that is now offered in the community.
2.2. Study design
The SHP (for study design, see Fig. 2) is a comparative
effectiveness trial of two augmented SDT-based interventions
relative to a standard intervention that included the 6 month
SDT–PHS based intervention previously shown to facilitate
long-term tobacco abstinence [15,16,18]. We decided against
inclusion of a no-treatment control group for the following
reasons:
1. When randomization in the SHP began, the 6 month SDT-
based intervention was supported by New York State and
Excellus BlueCross BlueShield for those who wanted to
stop smoking completely within 30 days, and thus had
become part of usual care in the region.
2. It would be unethical not to offer the 6 month SDT-based
intervention to those willing to be in the study because the
treatment was shown to be superior to the historical
control group, and because quality and length of life are
increased by smoking cessation [28,30].
3. If this treatment, which was available in the community,
was not offered to potential participants, then few would
enroll in the study.
4. Because the CC condition in the SHP was nearly equivalent
to the 6 month SDT-based intervention from our previous
trial [15,16,18], we could compare the three SHP inter-
ventions to the two groups from our previous trial without
increasing risk to those randomized to CC. Indeed, the PHS
Guideline [8] noted that no-treatment control groups limit
Table 1
A list of need-supportive behaviors derived from self-determination
theory.
Autonomy Support
1. Elicit and acknowledge the patient's perspectives and feelings
2. Explore the patient's values and how they relate to the behavior being
addressed
3. Provide a clear rationale for advice given
4. Provide effective options for change and acknowledge the option
of not changing
5. Support the patient's self-initiation for change
6. Minimize pressure and control
Competence Support
1. Be positive that the patient can succeed
2. Provide accurate, effectance-relevant feedback
3. Identify barriers to change
4. Engage the patient in skills-building and problem-solving
5. Develop a plan that is appropriate for the patient's abilities
6. Reframe failures as short successes
Relatedness Support
1. Develop empathy
2. Develop a warm, positive interpersonal relationship
3. Remain non-judgmental and provide unconditional positive regard
Need Support from
Health Care Climate
Change in PC for
Tobacco Abstinence
Change in ASR for
Tobacco Abstinence
and Medication Use
Medication Use
Tobacco Abstinence
Need Support from
Important Others
Fig. 1. The hypothesized path model depicting associations among measured constructs that will be tested in the SHP.
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the ability to determine a trial's efficacy. It would thus be
important to include our previous intervention as a CC
condition to determine the efficacy of the two augmented
SDT-based interventions compared to the new CC
standard.
The SHP is a pragmatic trial, as it includes smokers who
are typically excluded from efficacy trials, measures medica-
tion use (which is allowed to vary) rather than tries to
maximize medication use, and minimizes harm to those
randomized to CC by offering the 6 month SDT-based
intervention [31,32]. There is no run-in period prior to
randomization, which is often used to maximize motivation
for adhering to the protocol and medications prescribed
through attrition of those less motivated before randomiza-
tion. Rather, participants are randomized at their initial visit
after completing informed consent and baseline question-
naires, which reflects actual practice where patients accept or
decline treatment within the first visit or two. The SHP is a
cessation–induction trial, as it includes participants regard-
less of whether or not they want to stop smoking [33].
Participants with a history of chemical dependence, depres-
sion, or anxiety are accepted in the study because the SHP is
designed to reach a large percentage of adult smokers.
2.3. Recruitment, honoraria, and study outcomes
Participants are eligible if they have smoked at least 100
cigarettes in their lifetime, have smoked five or more
cigarettes per day during the four weeks prior to enrollment,
are at least 18 years of age, and can read and speak English.
Participants are recruited using IRB-approved newspaper,
bus, and radio advertisements; signs in medical facilities; and
mailings to patients in local physicians' practices. Impor-
tantly, participants are eligible whether or not they intend to
stop smoking. Participants are excluded for any of the
following reasons: pregnancy, psychotic illness, too sick to
participate, life expectancy of less than two years, and do not
plan to live in the area for two years. Participants are paid
$100 for completion of the study, and payment is pro-rated
based on the percentage completed. Participants do not pay
for counseling or prescription services. However, they do pay
for medications and medication co-pays, either out-of-pocket
or through their health insurance, and are eligible for
reimbursement of $150 from a grant provided to the SHP by
the American Lung Association in Rochester, New York.
The primary outcome is 12 month prolonged abstinence
from tobacco, which is assessed one year following termina-
tion of treatment (two years post-randomization) [33,34].
Smoker’s Health Project
Community Care (CC)
20% Randomized to CC
• A 6-month SDT-PHS based intensive
intervention.
• Promote ASR and PC within a context of
support for relatedness.
• Facilitate autonomous decision-making
about whether and how to initiate and
maintain tobacco abstinence.
• Participants who want to stop smoking
within 30 days are asked to have six contacts
over six months with study practitioners.
• Participants who do not want to stop
smoking within 30 days are asked to call
back when they are interested in stopping
and to see their primary care practitioner.
Extended Need Support (ENS)
40% Randomized to ENS
• Contains the same features as the 6
month SDT-PHS based intensive
intervention.
• Extend the SDT-based intensive
intervention to 12 months.
• Participants are expected to have six
contacts with study practitioners in the
first six months, and two contacts in the
next six months, whether they wanted to
stop or not.
• Participants are asked to identify one
important other with whom they have
regular contact and who is willing to
attend a 50-minute session at the study
site.
Harm Reduction (HR)
40% Randomized to HR
• Contains the same critical features (viz.,
12-month duration, important-other
training) as ENS.
• If participants do not want to stop smoking
completely within 30 days, prescribers
recommend first-line smoking-cessation
medications for the duration of the
intervention to those who are willing to
reduce their cigarette use by half.
Fig. 2. Study design of the Smoker's Health Project.
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Biochemical validation of the 12 month prolonged abstinence
from tobacco measure is not possible due to the short half life
of cotinine (36 h) and the brief time that carbon monoxide
takes to normalize after the last cigarette (8 h) [35].
Secondary outcomes include 7- and 30 day point prevalence
(7dPP and 30dPP) tobacco abstinence at six, 12, 18 and
24 months post-randomization, number of days using smok-
ing-cessation medication, change in ASR for tobacco absti-
nence and medication use during the first 12 months of the
study, change in PC during the first 12 months of the study,
and perceived need support from important others. Although
the SHP protocol recommends that participants receive 4–6
phone/office visits during the intervention, and they are
encouraged to keep these visits, care is taken to avoid
coercing participants into complying with an exact number
of contacts. Participants are able to schedule additional visits
during the intervention if desired.
2.4. The SHP interventions
2.4.1. Community care (CC)
The CC condition is a 6 month SDT-based intensive
intervention that is consistent with the PHS Guideline and
designed to promote ASR and PC within a context of support
for relatedness through unconditional positive regard. The
goal of CC is to facilitate autonomous decision-making about
whetherandhowto initiateandmaintaintobaccoabstinence.
Once the smoker indicates willingness to stop, the counselor
teaches skills building, problem solving, and provides
information on medications available as per the PHS
Guideline recommendations [8]. In addition, smokers who
indicate they wish to taper off cigarettes are taught a tapering
protocol [36] as a way to support ASR and PC. Participants
who indicate that they want to stop smoking within 30 days
are asked to have six contacts over six months with study
practitioners. Those who indicate that they do not want to
stop smoking within 30 days are asked to call back when they
are interested in stopping, as required by the locally
supported programs.
2.4.2. Extended need support (ENS)
The ENS provides all that the CC condition participants
receive and extends the SDT–PHS based intensive interven-
tion to 12 months, during which participants are expected to
have six contacts with study practitioners in the first six
months (at least one contact with a prescriber), and two
contacts in the next six months. Participants in both
augmented SDT-based interventions are asked to have the
same number of contacts with study practitioners regardless
of whether they intend to stop smoking. Participants are
asked to identify one important other (non-health-care
professional) with whom they have regular contact and
who is willing to attend a 50 min session at the study site.
Family and friends can be either autonomy supportive or
controlling, and have more daily interaction with participants
than do health care practitioners [26,37]. During their visit,
important others are asked to consider a behavior they want
tochangeandhowtheywouldwantto betreatedif theywere
to make that change, which is designed to elicit a set of need-
supportive behaviors. The important others are asked to
record these behaviors on a worksheet during their visit (see
Appendix A) and take the list home after the session. Once
these behaviors are elicited and discussed, important others
are asked to relate to the participant in that way. Important
others are also asked to watch a DVD with the participant,
which educates them on the health effects of smoking, the
health benefits of tobacco abstinence, the highly addictive
nature of nicotine, the effects and side effects of smoking-
cessation medication, typical withdrawal symptoms, and the
expected intensity and duration of withdrawal symptoms (6–
12 weeks).
2.4.3. Harm reduction (HR)
The HR condition contains the same critical features (viz.,
12 month duration, important-other training) as ENS. Addi-
tionally, if during the initial interview participants indicate
that they do not want to stop smoking completely within
30 days, or if they try to stop, fail, and do not want to make
another attempt within 30 days, prescribers recommend
first-line smoking-cessation medications for the duration of
the intervention to those who are willing to reduce their
cigarette use by half [38–45]. Participants are informed that
there is no evidence that reducing cigarette use improves
health, but doing so may increase confidence for stopping.
Drug side effects and potential toxicities are discussed, and
participants are asked whether they want to use a medica-
tion. The Federal DrugAdministration approvedthe use of the
medication protocol in this trial.
2.5. Training in need support
SHP practitioners include a tobacco-dependence counselor,
nurse, health educator, and health psychologist, and SHP
prescribers include a physician assistant and primary care
internist. All SHP practitioners receive approximately 25 h of
training todeliver the interventions in anautonomy-supportive
manner. Practitioners review the PHS Guideline, attend didactic
training on tobacco dependence, view training tapes on
motivational interviewing, read the Smoker's Health Manual,
observe four clinical interviews, and conduct four clinical
interviews in the presence of a supervisor. Once the supervisor
andpractitioneragreethattheinterventioncanbeadministered
efficaciously, the practitioner is able to see participants
independently. On-going supervision occurs every 2–4 weeks
throughout the study.
Practitioners are trained to consider participants' auton-
omy as the primary clinical goal. It is often thought that
autonomy support involves increasing the behavioral out-
come (e.g., tobacco abstinence or medication use), but this is
not necessarily the case, as autonomy support involves non-
judgmental acceptance of patients' reluctance to stop smok-
ing or use medication. Thus, a clinical encounter is considered
successful if the patient has greater clarity about whether to
make a change attempt and, if so, can develop a behavioral
and pharmacological plan to facilitate tobacco abstinence.
This secondary outcome is represented by change in ASR and
PC. Practitioners are taught to assume that all participants,
regardless of whether they want to stop, are ambivalent
about smoking. Those who do not want to stop may
experience conflict between the known health risks of
smoking and their inherent tendency toward health, whereas
those who do want to stop may experience conflict between
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their inherent tendency toward health and the consequences
of nicotine addiction and withdrawal. Said differently,
practitioners are trained to assume that smokers may feel
conflicted about their enjoyment of smoking and the risks
that smoking poses, and to elicit and acknowledge such
conflict by reflecting it to the patient. Finally, practitioners are
taught to give participants the responsibility to decide
whether or not they want to stop smoking and/or use
medications, and to provide a clear recommendation of
tobacco abstinence for all participants because smoking
cessation increases quality and length of life.
2.6. Support for autonomy
The following components of the interventions are
designed to support autonomy:
2.6.1. Eliciting and acknowledging participants' perspectives
and life aspirations
Practitioners ask participants about their experiences
regarding smoking and stopping, as well as their views on
the health consequences of smoking and the health benefits
of stopping. Participants are asked to identify several
important life aspirations and indicate how smoking may
help and/or hinder their attaining these goals [46]. This
discussion, which has been shown to facilitate long-term
tobacco abstinence, is intended to help participants and
understand how tobacco use fits into the participant's life
beforeconsideringan attemptto stopsmokinganddetermine
how best to make that change [19]. This exploration of values
is intended to facilitate integrated self-regulation—a form of
autonomous self-regulation.
2.6.2. Providing a clear rationale for change
Practitioners provide a clear rationale for change based on
participants' reasons for stopping,thehealth risks of smoking,
and the health benefits of stopping. Practitioners present an
individualized 10 year absolute risk for developing coronary
artery disease as a natural frequency to each participant [47].
For example, Mr. Smith, who has a 10 year absolute risk of
10%, is told that 1 in 10 individuals like him is expected to
have a heart attack, need bypass surgery or angioplasty, die
suddenly from a heart attack, or develop chest pain (angina)
from too little blood flow to the heart within the next
10 years. Mr. Smith is then asked how he feels about his level
of risk, and his response is reflected back to him. Next, he is
told that if he stopped smoking permanently, his risk for
having a cardiovascular event would be reduced by half
within one year and that only 1 in 20 individuals with that
risk is expected to have a cardiovascular event. Finally, Mr.
Smith is asked how he feels about that change in risk, and his
response is reflected back to him. This elicitation of and
reflection on the participant's perspective about the health
risks smoking poses is intended to facilitate internalization.
2.6.3. Providing effective options for change
Practitioners provide each participant with a clear recom-
mendation to stop smoking so as to improve health, extend
length of life, and improve quality of life. Practitioners recom-
mend behavioral counseling and medication use for those
participants without contraindications. Providing participants
with choice among effective options for change is intended to
enhance autonomy, yet practitioners are mindful not to offer an
overwhelming list of options. Practitioners give a clinical
recommendationifparticipantshavedifficultymakingadecision
about treatment options, or if participants solicit their advice.
2.6.4. Supporting self-initiations for change
Practitioners solicit participants' input on whether or not
they want to stop smoking. If participants are not ready to
stop, practitioners acknowledge this and ask them to return
in two months for further discussion. If participants are ready
to stop, practitioners ask them about how they want to
proceed with the health-behavior change. For instance, many
participants have used medications in the past with varying
levels of success. Practitioners explore these experiences and
ask the participants if they prefera particular medication over
another. If yes, practitioners provide instructions on effective
use and side effects of the chosen drug, and answer any
related questions. A recommendation is provided only if
requested by participants. Importantly, an office or phone
follow-up is scheduled (typically within 1–3 days) to discuss
how the method is working in an open, non-judgmental
manner.
2.6.5. Minimizing pressure and control
Practitioners explore participants' perspectives before
giving a clinical recommendation and acknowledge when
participants do not want to use treatment or schedule a visit
within a particular time. Both the SHP protocol and informed
consent form indicate that participants need not intend to
stop smoking or make a stop attempt during the intervention
in order tobe enrolled. After the intervention,participants are
referred to their primary-care practitioner for ongoing care.
2.7. Support for competence
Support for competence is intended to enhance partici-
pants' perceptions that they can attain their behavior-change
goals and increase the actual percentage of those who
succeed. From an SDT perspective, only those who feel
volitional (autonomous) to make a change attempt are
expected to benefit from competence support [14]. Thus,
SHP practitioners are trained to focus predominantly on
supporting autonomy and relatedness until participants
indicate an intent to stop smoking, after which competence
is supported directly along with autonomy and relatedness.
Teaching participants how to make a change attempt may be
met with resistance if they are not ready to learn such
approaches. If participants request information on how to
stop smoking before establishing an intention to change,
practitioners answer those requests directly, as refusing to do
so may be perceived as controlling and/or judgmental by
participants.
The following components of the interventions are
designed to support competence:
2.7.1. Offering effectance-relevant feedback
Practitioners give participants information on how cigarettes
work (rapid delivery of nicotine by the tars), the nature of
nicotine addiction (short half-life of tobacco, duration and
expected pattern of withdrawal symptoms), effects of tobacco
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use on weight (appetite suppression, increased metabolic rate),
and how medications work to relieve withdrawal symptoms
(anxiety, constipation, craving, dysphoric mood, headaches,
increased appetite, irritability, trouble concentrating). Providing
this information in a non-judgmental manner is intended to
enhance ASR and PC, which can avoid undermining need
satisfaction and eliciting reactance toward the intervention.
2.7.2. Helping to establish a behavior-change plan
Practitioners work with participants to establish a plan to
stop smoking and manage withdrawal symptoms. Using a
PHS worksheet, those who are willing to make an attempt to
stop smoking specify a stop date, select a medication to
manage withdrawal symptoms, receive skills-building and
problem-solving training, ask others for support, and arrange
a follow-up meeting with a study practitioner.
2.8. Support for relatedness
The following components of the interventions are
designed to support relatedness:
2.8.1. Relating to participants in an empathic, non-judgmental
manner
Practitioners (and, for those in ENS and HR, important
others) are taught to relate to participants in an empathic,
non-judgmental manner even if participants are not ready to
stop smoking. Such a caring, accepting, and encouraging style
embodies the concept of unconditional positive regard and is
consistent with the PHS Guideline. Practitioners reframe
failed attempts at smoking cessation as ‘short successes’ and
elicit participants' interpretations of these events [48].
2.8.2.Definingtheinterventionbytimeratherthannumberofvisits
The intervention is defined by the period of time that
treatment is available, rather than the number of visits made
by participants. Offering a time period of available support is
expected to enhance relatedness and, to some extent,
autonomy because participants differ in the amount of
support needed to reach their goals. If the number of visits
is fixed, then participants may feel more pressured and less
able to develop quality relationships with study practitioners.
2.9. Sample size calculations
Power analyses are done using the formula for differences
in proportions [49] with a two-tailed alpha of .05 (with
Bonferroni adjustment to .025) and a power of 80%. Based on
our previous randomized clinical trial testing the intensive
SDT–PHS intervention [16], our previous randomized clinical
trial of a brief intervention for physicians to motivate
cessation [50], results of several studies on providing
medications to smokers who are willing to reduce their
cigaretteusebutwhoare notwillingtostopsmoking[38–45],
and results of the PHS meta-analysis, we estimate 12 month
prolonged abstinence rates at 24 months for the three
conditions to be 4% in CC, 14% in ENS, and 23% in HR. We
planned to randomize 20% of enrollees to CC, 40% to ENS, and
40% to HR. With an intention-to-treat analysis, the sample
size needed to detect a significant difference between ENS
and HR is 353 participants per condition. With 353 partici-
pants in ENS, a sample size of 112 in CC is more than adequate
to detect a significant difference between ENS and CC. The
necessary condition sizes to detect the other hypothesized
effects are all less than 220. Thus, we plan for a total of 818
participants, with 112 participants randomized to CC and 353
participants randomized to both ENS and HR.
2.10. Assessments
Various questionnaire assessments (described below) are
performed at the beginning of the intervention (baseline),
and at two, four, six, 12, and 18 months post-randomization.
2.10.1. Autonomous self-regulation for tobacco abstinence and
medication use
The Treatment Self-Regulation Questionnaire [51,52]
presents participants with the following stems: “The reason
I would stop smoking permanently or continue not smoking
is…” and “The reason I would use medication as recom-
mended is…” Participants rate pre-selected responses asses-
sing external (4 items; e.g., “Because I want others to approve
of me”.), introjected (3 items; e.g., “Because I would feel bad
about myself if I smoked”.), identified (4 items; e.g., “Because
it is very important for being as healthy as possible.”), and
integrated (2 items; e.g., “Because using medication to stop
smoking permanently is consistent with my life goals.”)
reasons for behavior change. Responses are made on a
7-point scale from 1 (strongly disagree) to 7 (strongly agree).
2.10.2. Perceived competence
The Perceived Competence Scale [15,16,51] assesses
participants' experience of feeling able to stop smoking
successfully (4 items; e.g., I feel confident in my ability to
stopsmoking permanently). Responsesare made ona 7-point
scale from 1 (strongly disagree) to 7 (strongly agree).
2.10.3. Perceived need support from health care practitioners
The Health Care Climate Questionnaire [15,16,51] assesses
participants' experience of need support from their health-
care practitioner in consulting with them on their smoking or
stopping (15 items; e.g., I feel that my counselor has provided
me with choices and options about my smoking). Responses
are made on a 7-point scale from 1 (strongly disagree) to 7
(strongly agree).
2.10.4. Perceived need support from important others
The Important Other Questionnaire [15,16,51] assesses
participants' experience of need support from important
others (non-health care professionals) regarding their smok-
ing or stopping (6 items; e.g., I feel that my important other
has provided me with choices and options about smoking,
including quitting or not). Responses are made on a 7-point
scale from 1 (strongly disagree) to 7 (strongly agree).
2.11. Analytic overview
AnalysisofVariance(ANOVA)isusedtotestgroupdifferences
on the primary and secondary outcomes with “intention-to-
treat” data, in which all participants are included. Structural
Equation Modeling (SEM) is used to test the hypothesized path
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Page 8

model (see Fig. 1) with “as-reported” data, in which only
available responses are included.
3. Conclusion
3.1. Major decision points
It is important to discuss some of the major decisions
made in the design of the SHP.
1. The SHP is a pragmatic comparative effectiveness trial that
is characterized by the absence of a run-in period and
inclusion of smokers who are typically excluded from
efficacy trials. Such a design broadens the applicability of
results to real-world smokers. Further, greater variation in
motivation among participants at baseline allows for a
better test of whether the interventions facilitated inter-
nalization and tobacco abstinence.
2. The theoretical framework for the SHP is SDT, which
defines maintenance as sustained change over time after
the intervention has ended. As such, we expect lower
absolute rates of prolonged abstinence from tobacco,
relative to trials that require fewer months of health-
behavior change and include booster sessions designed to
enhance maintenance.
3. Participants are randomized to one of the three intensive
interventions without inclusion of a no-treatment control
group. This decision comes at the risk of not finding
significant group differences in tobacco abstinence, but
such risk is attenuated by having data available from our
previous trial, which included a no-treatment control
group. Indeed, we feel there is much greater risk to the
participants in randomizing smokers to a no-treatment
control group than from failing to find significant group
differences.
4. There are three differences between the CC and ENS
interventions, namely, extending the duration of the
intervention from six to 12 months, contact with study
practitioners regardless of whether participants want to
stop smoking within 30 days, and training important
others to support smokers' basic psychological needs. We
allow for this because the SHP is designed as a pragmatic
trial and because we measure perceived need support
from health-care practitioners and important others,
which can be used to determine if specific mediators of
treatment effects are affected in theoretically consistent
ways.
3.2. Summary
The SHP is a pragmatic comparative effectiveness trial of
three SDT-based intensive tobacco-dependence interven-
tions. Herein, we presented an overview of the SHP and
described in detail the need-supportive components of the
interventions, which are intended to facilitate long-term
tobacco abstinence through internalization of ASR for tobacco
abstinence and medication use, enhanced PC, and support for
relatedness from both health-care practitioners and impor-
tant others. Comparisons among the intervention groups will
determine whether (1) extending the duration of the
intervention from six to 12 months and teaching important
others tosupport smokers'basic psychological needsenhance
ASR, PC, medication use, and maintenance of tobacco
abstinence (CC vs. ENS), and (2) recommending medication
use for participants who do not want to stop smoking
completely within30 days but who are willing to reduce their
cigarette use by half enhances these same outcomes (ENS vs.
HR).
Supplementary materials related to this article can be
found online at doi:10.1016/j.cct.2011.03.002.
Acknowledgements
Geoffrey C. Williams, Christopher P. Niemiec, Richard M.
Ryan, Edward L. Deci, and Holly McGregor Lavigne, Depart-
ment of Clinical and Social Sciences in Psychology, University
of Rochester. Dr. Williams and Dr. McGregor Lavigne are also
members of the Department of Medicine, and the Healthy
Living Research Center in the Center for Community Health at
University of Rochester. Heather Patrick, National Cancer
Institute, Division of Cancer Control and Population Sciences,
Behavioral Research Program, Health Promotion Research
Branch.
This research was supported by grants from the National
Cancer Institute [R01-CA106668] awarded to Dr. Geoffrey
Williams, MD, PhD; the National Institute of Mental Health
and the National Cancer Institute [R01-MH059594] awarded
to Dr. Geoffrey Williams, MD, PhD; the National Center for
Research Resources [M01-RR00044] awarded to the Univer-
sity of Rochester General Clinical Research Center; and the
National Center for Research Resources ARRA Supplement
[UL1RR024160] awarded to the University of Rochester's
Clinical and Translational Science Institute.
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