Cigarette Smoking
Conditions
Keywords
Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight
Brief summary
The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are: 1. Study the feasibility of an individually-tailored telephone intervention for rural smokers. 2. Examine the impact of the intervention on tobacco use outcomes. 3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.
Detailed description
Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers. Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care. In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.
Interventions
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
BEHAVIORALTailored behavioral intervention
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
BEHAVIORALTobacco quit line referral
Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGVarenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
BEHAVIORALAlcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
BEHAVIORALBehavioral activation for the treatment of depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
BEHAVIORALBehavioral management of post-cessation weight gain
Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
Sponsors
US Department of Veterans Affairs
Iowa City Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Being a veteran * 18 + years of age * Smoke cigarettes on at least a daily basis * Receive primary care from the Iowa City VAMC or Coralville Clinic * Live in a non-metropolitan area (based on RUCA codes) * Be willing to make a quit attempt in the next 30 days * Be capable of providing informed consent * Have access to a telephone (land line or cell phone) * Have a stable residence
Exclusion criteria
* Planning to move within the next 12 months * Presence of a terminal illness * Pregnancy * Unstable psychiatric disorder (e.g., acute psychosis) * Currently pregnant * Incarcerated * Institutionalized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | End of treatment (seven weeks after baseline) | Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | Six-month follow-up | Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group. |
| Depressive Symptoms | Six-month follow-up | Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. |
| Body Weight | Six-month follow-up | Self-reported body weight. |
| Number of Participants Abstinent From Tobacco Use | Six-month follow-up | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence). |
| Retention | End of treatment (seven weeks after baseline) | The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach. |
| Treatment Attendance | End of treatment (seven weeks after baseline) | The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach. |
| Enrollment Rate | 6 months after study initiation | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailored Intervention Group Participants will receive a combined behavioral and pharmacological intervention.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. | 31 |
| Enhanced Standard of Care Group Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination.
Tobacco quit line referral: Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 4 |
Baseline characteristics
| Characteristic | Enhanced Standard of Care Group | Total | Tailored Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 55 Participants | 26 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 8.8 | 56.8 years STANDARD_DEVIATION 10.3 | 55.1 years STANDARD_DEVIATION 11.5 |
| Age of smoking initiation | 15.8 years STANDARD_DEVIATION 2.8 | 16.2 years STANDARD_DEVIATION 3.1 | 16.7 years STANDARD_DEVIATION 3.4 |
| Cigarettes smoked per day | 27.2 cigarettes/day STANDARD_DEVIATION 25.7 | 24.7 cigarettes/day STANDARD_DEVIATION 19.4 | 22.3 cigarettes/day STANDARD_DEVIATION 10.3 |
| Nicotine dependence | 5.7 units on a scale STANDARD_DEVIATION 2.1 | 5.7 units on a scale STANDARD_DEVIATION 2.2 | 5.6 units on a scale STANDARD_DEVIATION 2.3 |
| Prior quit attempts lasting at least 24 hours | 9.4 quit attempts STANDARD_DEVIATION 19.6 | 8.0 quit attempts STANDARD_DEVIATION 15 | 6.6 quit attempts STANDARD_DEVIATION 8.1 |
| Readiness to quit smoking | 6.5 units on a scale STANDARD_DEVIATION 1.3 | 6.6 units on a scale STANDARD_DEVIATION 1.2 | 6.8 units on a scale STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 32 Participants | 63 Participants | 31 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 27 Participants | 55 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Treatment Satisfaction
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Time frame: End of treatment (seven weeks after baseline)
Population: Participants who completed treatment satisfaction items on three-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tailored Intervention Group | Treatment Satisfaction | Liked that treatment was delivered by phone | 21 Participants |
| Tailored Intervention Group | Treatment Satisfaction | Found treatment very or extremely useful | 17 Participants |
| Tailored Intervention Group | Treatment Satisfaction | Found medication to be very or extremely useful | 16 Participants |
| Tailored Intervention Group | Treatment Satisfaction | Found treatment to be very or extremely convenient | 16 Participants |
| Tailored Intervention Group | Treatment Satisfaction | Found treatment to be very or extremely difficult | 5 Participants |
| Enhanced Standard of Care Group | Treatment Satisfaction | Found treatment to be very or extremely difficult | 5 Participants |
| Enhanced Standard of Care Group | Treatment Satisfaction | Found treatment to be very or extremely convenient | 9 Participants |
| Enhanced Standard of Care Group | Treatment Satisfaction | Found treatment very or extremely useful | 6 Participants |
| Enhanced Standard of Care Group | Treatment Satisfaction | Liked that treatment was delivered by phone | 10 Participants |
| Enhanced Standard of Care Group | Treatment Satisfaction | Found medication to be very or extremely useful | 7 Participants |
Secondary
Alcohol Use
Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.
Time frame: Six-month follow-up
Population: Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Intervention Group | Alcohol Use | 9.5 Drinks consumed per day | Standard Deviation 0.7 |
| Enhanced Standard of Care Group | Alcohol Use | 2.8 Drinks consumed per day | Standard Deviation 3.2 |
Secondary
Body Weight
Self-reported body weight.
Time frame: Six-month follow-up
Population: Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Intervention Group | Body Weight | 214.0 Pounds | Standard Deviation 38.1 |
| Enhanced Standard of Care Group | Body Weight | 228.2 Pounds | Standard Deviation 45.5 |
Secondary
Depressive Symptoms
Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.
Time frame: Six-month follow-up
Population: Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Intervention Group | Depressive Symptoms | 7.0 units on a scale | Standard Deviation 5.4 |
| Enhanced Standard of Care Group | Depressive Symptoms | 3.9 units on a scale | Standard Deviation 2.7 |
Secondary
Enrollment Rate
The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
Time frame: 6 months after study initiation
Population: Total number of participants randomized to each treatment condition.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Intervention Group | Enrollment Rate | 31 Participants |
| Enhanced Standard of Care Group | Enrollment Rate | 32 Participants |
Secondary
Number of Participants Abstinent From Tobacco Use
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).
Time frame: Six-month follow-up
Population: 7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Intervention Group | Number of Participants Abstinent From Tobacco Use | 9 Participants |
| Enhanced Standard of Care Group | Number of Participants Abstinent From Tobacco Use | 9 Participants |
Secondary
Retention
The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
Time frame: End of treatment (seven weeks after baseline)
Population: Participants assigned to the tailored intervention condition who completed the intervention calls.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tailored Intervention Group | Retention | 16 Participants |
Secondary
Treatment Attendance
The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
Time frame: End of treatment (seven weeks after baseline)
Population: Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tailored Intervention Group | Treatment Attendance | 4.0 Calls |