Telephone-based Smoking Cessation

Purpose: Cigarette smoking is the single greatest cause of preventable deaths. In the VA
health care system, patients with chronic medical illnesses represent an important population
on which to focus smoking cessation efforts. Smoking cessation among patients with chronic
medical illnesses can substantially decrease morbidity and mortality. Despite these benefits,
many patients with chronic medical illnesses continue to smoke. There is a strong
interrelationship between depression and chronic medical illness. Depression can derail
sustained smoking cessation and may be an important barrier to smoking cessation for Veterans
with chronic medical illness. Despite the barriers they face, smokers with depression are
motivated to quit smoking. Smokers with histories of depression may respond better to smoking
cessation interventions that are augmented with mood-management adjuncts such as
mood-management counseling. Thus, depressed smokers are more likely to quit when behavioral
mood-management is added to traditional cessation approaches. Yet, the augmentation of
smoking cessation with behavioral mood management is not yet firmly established. Also these
intensive interventions have limited reach when conducted in person. Telephone counseling can
deliver intensive and effective treatment to people who smoke, yet its implementation has
been limited among smoker with depression. There is a need to develop novel proactive
telephone-delivered approaches that can broadly deliver intensive smoking cessation
interventions to Veterans who may not respond to standard care, such as those with chronic
medical illnesses and depressive symptoms.

Methodology: The investigators propose a randomized comparative effectiveness trial with a
two-group design in which 350 Veteran smokers with depression and chronic medical illness
will be randomized to either: 1) smoking cessation plus adjunctive behavioral mood management
(SMK-MM group), an intervention that includes a proactive telehealth intervention that
combines evidence-based smoking cessation counseling augmented with behavioral mood
management and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2)
smoking cessation telephone counseling control (SMK CONTROL), a contact-equivalent control
that provides the same smoking cessation telephone counseling intervention augmented with
health education (instead of mood-management) and a tele-medicine clinic for accessing NRT.
Patients with chronic medical illnesses will be identified from patient intake systems of the
Durham Veteran's Affairs Hospital and screened for tobacco use and depressive symptoms.

The main outcome in this trial is prolonged abstinence at 6-month and 12-month follow-up.
Logistic regression will be used to test for a between-group difference in the proportion of
patients with self-reported prolonged abstinence from cigarettes at 6 months. A general
linear mixed model will be used to estimate changes depressive symptoms between groups. If
there is a significant intervention effect on smoking cessation, mediational analysis will be
conducted to examine whether changes in self-efficacy or affect mediate the impact of the
mood management intervention.

Objectives: The specific aims of the study are to 1) evaluate the impact of a
telephone-delivered smoking cessation intervention augmented with behavioral mood management
on rates of prolonged and point prevalence abstinence from cigarettes among Veterans with
chronic medical illnesses and depression; 2) monitor the impact of behavioral mood management
intervention on depressive symptoms; 3) if effective, assess whether change in self-efficacy
as well as positive and negative affect mediate the impact of behavioral mood management
intervention on smoking cessation among Veterans; and 4) assess the cost-effectiveness if the
mood-enhanced intervention.

Inclusion Criteria:

Patients must meet all of the following inclusion criteria:

- 1.Enrolled in the Durham VAMC for ongoing care

- 2.Current tobacco smokers planning to quit smoking in the next 30 days

- 3.Having received a diagnosis of a qualifying chronic illness (i.e., cancer,
cardiovascular disease, hypertension, diabetes, COPD)

- 4.Have significant burden of depressive symptoms (i.e., meets DSM threshold for > 3 of
the nine MDD criterion symptoms at the threshold of "more than half the days" (one
symptom must be depressed mood or anhedonia; endorsing "some days" meets criteria for
self-harm) and endorse functional impairment OR receive a summary score 10 or above on
PHQ-9.

Exclusion Criteria:

Patients who meet any one of the following exclusion criteria will be excluded:

- 1.Active diagnosis of psychosis or dementia in their medical records

- 2.Severely impaired hearing or speech

- 3.Lack of telephone access

- 4.Enrollment in another research study that might affect the main outcomes of this
study

- 5.Terminal illness

- 6. Behavioral flag in medical record

- 7. Active suicidal ideation flag in medical record

- 8. Endorses thoughts of self-harm and is a greater than minimal risk of suicide