Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity
Overview
- Phase
- Phase 2
- Intervention
- Tailored behavioral intervention
- Conditions
- Cigarette Smoking
- Sponsor
- Iowa City Veterans Affairs Medical Center
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Treatment Satisfaction
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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:
- Study the feasibility of an individually-tailored telephone intervention for rural smokers.
- Examine the impact of the intervention on tobacco use outcomes.
- 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.
Investigators
Mark Vander Weg
Research Specialist
Iowa City Veterans Affairs Medical Center
Eligibility Criteria
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
Arms & Interventions
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Tailored behavioral intervention
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Nicotine replacement therapy - transdermal nicotine patch
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Nicotine replacement therapy - nicotine gum
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Nicotine replacement therapy - nicotine lozenge
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Bupropion Sustained Release
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Varenicline
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Alcohol use risk reduction
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Behavioral activation for the treatment of depression
Tailored Intervention Group
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
Intervention: Behavioral management of post-cessation weight gain
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.
Intervention: Nicotine replacement therapy - transdermal nicotine patch
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.
Intervention: Tobacco quit line referral
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.
Intervention: Nicotine replacement therapy - nicotine gum
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.
Intervention: Nicotine replacement therapy - nicotine lozenge
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.
Intervention: Bupropion Sustained Release
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.
Intervention: Varenicline
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.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
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.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
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.
Intervention: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Outcomes
Primary Outcomes
Treatment Satisfaction
Time Frame: 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 Outcomes
- Number of Participants Abstinent From Tobacco Use(Six-month follow-up)
- Alcohol Use(Six-month follow-up)
- Depressive Symptoms(Six-month follow-up)
- Body Weight(Six-month follow-up)
- Enrollment Rate(6 months after study initiation)
- Retention(End of treatment (seven weeks after baseline))
- Treatment Attendance(End of treatment (seven weeks after baseline))