Trial Outcomes & Findings for Adjunctive Mood Management for Telephone-based Smoking Cessation (NCT NCT02500589)

Last Updated: 2023-07-27

Results Overview

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."

Recruitment status

COMPLETED

Study phase

Target enrollment

350 participants

Primary outcome timeframe

6 month

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Mood Management Enhancement In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Overall Study STARTED	175	175
Overall Study COMPLETED	147	143
Overall Study NOT COMPLETED	28	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Mood Management Enhancement In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Overall Study Withdrawal by Subject	11	14
Overall Study Lost to Follow-up	10	12
Overall Study Excluded post rand: cognitive impairment	0	1
Overall Study Death	7	5

Baseline Characteristics

Adjunctive Mood Management for Telephone-based Smoking Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mood Management Enhancement n=175 Participants 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	Health Education Control n=175 Participants 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	Total n=350 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 8.3 • n=5 Participants	61.8 years STANDARD_DEVIATION 7.7 • n=7 Participants	62.2 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	157 Participants n=7 Participants	313 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	88 Participants n=5 Participants	96 Participants n=7 Participants	184 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	73 Participants n=7 Participants	147 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	175 Participants n=5 Participants	175 Participants n=7 Participants	350 Participants n=5 Participants
Cigarettes per day 10 or less	67 Participants n=5 Participants	64 Participants n=7 Participants	131 Participants n=5 Participants
Cigarettes per day 11 -20	76 Participants n=5 Participants	77 Participants n=7 Participants	153 Participants n=5 Participants
Cigarettes per day 21-30	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Cigarettes per day 31+	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Number of Participants With Prolonged Abstinence	36 Participants	40 Participants

PRIMARY outcome

Timeframe: 12 month

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."

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Number of Participants With Prolonged Abstinence	32 Participants	33 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Number of Participants With 7 Day Point Prevalent Abstinence	37 Participants	35 Participants

SECONDARY outcome

Timeframe: change from baseline to 6 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 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months	-4.53 score on a scale Standard Error 0.33	-3.65 score on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: change 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.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up	-5.09 units on a scale Standard Error 0.34	-4.84 units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=11 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=12 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Biochemical Verification of Smoking Cessation at 6 Month Follow up	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 month

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.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=175 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=175 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Number of Participants With 7 Day Point Prevalent Abstinence	34 Participants	36 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mood Management Enhancement n=19 Participants In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Behavioral 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.	Health Education Control n=13 Participants 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 personal health care. Participants also will receive chronic-disease-specific self-management information. Health 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.
Biochemical Verification of Smoking Cessation at 12 Month Follow up	17 Participants	9 Participants

Adverse Events

Mood Management Enhancement

Serious events: 15 serious events

Other events: 82 other events

Deaths: 7 deaths

Health Education Control

Serious events: 15 serious events

Other events: 105 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Mood Management Enhancement n=175 participants at risk 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	Health Education Control n=175 participants at risk 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 symptom
Blood and lymphatic system disorders Hospitlization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	0.00% 0/175 • 12 months from time of consent
Cardiac disorders Hospitalization	2.3% 4/175 • Number of events 4 • 12 months from time of consent	1.7% 3/175 • Number of events 3 • 12 months from time of consent
Infections and infestations Hospitalization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	1.1% 2/175 • Number of events 3 • 12 months from time of consent
Injury, poisoning and procedural complications Hospitalization	1.7% 3/175 • Number of events 3 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Metabolism and nutrition disorders Hospitalization	0.00% 0/175 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	0.00% 0/175 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Nervous system disorders Hospitalization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Psychiatric disorders Hospitalization	0.00% 0/175 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Respiratory, thoracic and mediastinal disorders Hospitalization	3.4% 6/175 • Number of events 6 • 12 months from time of consent	2.3% 4/175 • Number of events 4 • 12 months from time of consent
Surgical and medical procedures Hospitalization	1.7% 3/175 • Number of events 3 • 12 months from time of consent	1.7% 3/175 • Number of events 5 • 12 months from time of consent
Vascular disorders Hospitalization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	0.57% 1/175 • Number of events 1 • 12 months from time of consent
Infections and infestations Prolongation of Hospitalization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	0.00% 0/175 • 12 months from time of consent
Injury, poisoning and procedural complications Prolongation of Hospitalization	0.57% 1/175 • Number of events 1 • 12 months from time of consent	0.57% 1/175 • Number of events 2 • 12 months from time of consent

Other adverse events

Other adverse events
Measure	Mood Management Enhancement n=175 participants at risk 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	Health Education Control n=175 participants at risk 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 symptom
Psychiatric disorders Increased feelings of irritation, stress, or anxiety	22.3% 39/175 • Number of events 47 • 12 months from time of consent	31.4% 55/175 • Number of events 88 • 12 months from time of consent
General disorders Flu, cold, virus, seasonal allergies, or general illness	12.6% 22/175 • Number of events 23 • 12 months from time of consent	12.0% 21/175 • Number of events 29 • 12 months from time of consent
Musculoskeletal and connective tissue disorders Bodily Pain	7.4% 13/175 • Number of events 15 • 12 months from time of consent	5.1% 9/175 • Number of events 32 • 12 months from time of consent
General disorders Craving for cigarettes	4.6% 8/175 • Number of events 14 • 12 months from time of consent	11.4% 20/175 • Number of events 29 • 12 months from time of consent

Additional Information

Jennifer Gierisch

Durahm VA Health Care System

Phone: 919-286-0411

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place