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Adjunctive Mood Management for Telephone-based Smoking Cessation

Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02500589
Enrollment
350
Registered
2015-07-16
Start date
2016-05-31
Completion date
2019-04-19
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

smoking, tobacco

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.

Interventions

BEHAVIORALBehavioral mood management

The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls.

OTHERHealth education

In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Prolonged Abstinence6 monthIn keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, Since \[end of the grace period\] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days? and After \[end of the grace period\] has the participant smoked any in each of 2 consecutive weeks? Responding no to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding no.

Secondary

MeasureTime frameDescription
Number of Participants With 7 Day Point Prevalent AbstinenceMonth 6At each follow-up (6 month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking.
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-monthschange from baseline to 6 month follow upPatients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow upchange from baseline to 12 month follow upPatients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 12 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.
Biochemical Verification of Smoking Cessation at 6 Month Follow up6 month follow upSaliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 6 months via biochemical validation of of saliva samples.
Biochemical Verification of Smoking Cessation at 12 Month Follow up12 month follow upSaliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 12 months via biochemical validation of of saliva samples.

Countries

United States

Participant flow

Participants by arm

ArmCount
Mood Management Enhancement
US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the mood management enhanced smoking cessation arm
175
Health Education Control
US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms randomized to the health education attention control smoking cessation arm
175
Total350

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath75
Overall StudyExcluded post rand: cognitive impairment01
Overall StudyLost to Follow-up1012
Overall StudyWithdrawal by Subject1114

Baseline characteristics

CharacteristicHealth Education ControlTotalMood Management Enhancement
Age, Continuous61.8 years
STANDARD_DEVIATION 7.7
62.2 years
STANDARD_DEVIATION 8
62.7 years
STANDARD_DEVIATION 8.3
Cigarettes per day
10 or less
64 Participants131 Participants67 Participants
Cigarettes per day
11 -20
77 Participants153 Participants76 Participants
Cigarettes per day
21-30
22 Participants41 Participants19 Participants
Cigarettes per day
31+
12 Participants25 Participants13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
96 Participants184 Participants88 Participants
Race (NIH/OMB)
More than one race
1 Participants9 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants2 Participants
Race (NIH/OMB)
White
73 Participants147 Participants74 Participants
Region of Enrollment
United States
175 Participants350 Participants175 Participants
Sex: Female, Male
Female
18 Participants37 Participants19 Participants
Sex: Female, Male
Male
157 Participants313 Participants156 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 1755 / 175
other
Total, other adverse events
82 / 175105 / 175
serious
Total, serious adverse events
15 / 17515 / 175

Outcome results

Primary

Number of Participants With Prolonged Abstinence

In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, Since \[end of the grace period\] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days? and After \[end of the grace period\] has the participant smoked any in each of 2 consecutive weeks? Responding no to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding no.

Time frame: 6 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementNumber of Participants With Prolonged Abstinence36 Participants
Health Education ControlNumber of Participants With Prolonged Abstinence40 Participants
Primary

Number of Participants With Prolonged Abstinence

In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, Since \[end of the grace period\] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days? and After \[end of the grace period\] has the participant smoked any in each of 2 consecutive weeks? Responding no to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding no.

Time frame: 12 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementNumber of Participants With Prolonged Abstinence32 Participants
Health Education ControlNumber of Participants With Prolonged Abstinence33 Participants
Secondary

Biochemical Verification of Smoking Cessation at 12 Month Follow up

Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 12 months via biochemical validation of of saliva samples.

Time frame: 12 month follow up

Population: There were 32 participants who returned a sample and were not on NRT. We used a cotinine cutpoint of 15ng/mL for those not on NRT and not exposed to secondhand smoke. For those who self-reported secondhand smoke exposure, we used a cutpoint of 18ng/mL. This outcome is the number of participants whose cotinine results confirm self-report status of not smoking at the 12-month assessment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementBiochemical Verification of Smoking Cessation at 12 Month Follow up17 Participants
Health Education ControlBiochemical Verification of Smoking Cessation at 12 Month Follow up9 Participants
Secondary

Biochemical Verification of Smoking Cessation at 6 Month Follow up

Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 6 months via biochemical validation of of saliva samples.

Time frame: 6 month follow up

Population: There were 23 participants who returned a sample and were not on NRT. We used a cotinine cutpoint of 15ng/mL for those not on NRT and not exposed to secondhand smoke. For those who self-reported secondhand smoke exposure, we used a cutpoint of 18ng/mL. This outcome is the number of participants whose cotinine results confirm self-report status of not smoking at the 6-month assessment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementBiochemical Verification of Smoking Cessation at 6 Month Follow up10 Participants
Health Education ControlBiochemical Verification of Smoking Cessation at 6 Month Follow up10 Participants
Secondary

Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up

Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 12 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.

Time frame: change from baseline to 12 month follow up

ArmMeasureValue (MEAN)Dispersion
Mood Management EnhancementChange in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up-5.09 units on a scaleStandard Error 0.34
Health Education ControlChange in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up-4.84 units on a scaleStandard Error 0.35
Secondary

Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months

Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.

Time frame: change from baseline to 6 month follow up

ArmMeasureValue (MEAN)Dispersion
Mood Management EnhancementChange in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months-4.53 score on a scaleStandard Error 0.33
Health Education ControlChange in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months-3.65 score on a scaleStandard Error 0.34
Secondary

Number of Participants With 7 Day Point Prevalent Abstinence

At each follow-up (12-month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking.

Time frame: 12 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementNumber of Participants With 7 Day Point Prevalent Abstinence34 Participants
Health Education ControlNumber of Participants With 7 Day Point Prevalent Abstinence36 Participants
Secondary

Number of Participants With 7 Day Point Prevalent Abstinence

At each follow-up (6 month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking.

Time frame: Month 6

Population: US veteran smokers willing to try a tobacco quit attempt with a diagnosis of a qualifying chronic illness (i.e., cancer, CVD, hypertension, diabetes, COPD), and having significant burden of depressive symptoms

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mood Management EnhancementNumber of Participants With 7 Day Point Prevalent Abstinence37 Participants
Health Education ControlNumber of Participants With 7 Day Point Prevalent Abstinence35 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026