Clinical trial NCT02500589: Adjunctive Mood Management for Telephone-based Smoking Cessation
Official title: Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: smoking
tobacco
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-07-16
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Prolonged Abstinence
timeFrame: 6 month
measure: Number of Participants With Prolonged Abstinence
timeFrame: 12 month
Secondary outcomes:
measure: Number of Participants With 7 Day Point Prevalent Abstinence
timeFrame: Month 6
measure: Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months
timeFrame: change from baseline to 6 month follow up
measure: Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up
timeFrame: change from baseline to 12 month follow up
measure: Biochemical Verification of Smoking Cessation at 6 Month Follow up
timeFrame: 6 month follow up
measure: Number of Participants With 7 Day Point Prevalent Abstinence
timeFrame: 12 month
measure: Biochemical Verification of Smoking Cessation at 12 Month Follow up
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Jennifer M Gierisch, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: