Iowa City VA Health Care System
Iowa City, Iowa, 52246, United States
NCT Number: NCT01592695
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.
Looking for future studies?
Notify Me18 year–99 year
All sexes
Interventional
Phase 2
Iowa City, Iowa, 52246, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
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
Other names: Zyban
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
Other names: Chantix
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
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Other names: Risky alcohol use, Harm reduction
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Other names: Depression
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.
Other names: Weight management
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Six-month follow-up
Self-reported body weight.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Iowa City Veterans Affairs Medical Center
Fed
Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04188197
Behavior, Chemically-Induced Disorders
Charlotte, North Carolina, United States
View Trial DetailsNCT05095779
Behavior, Chemically-Induced Disorders
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT04159571
Addiction, Addiction Nicotine
Winston-Salem, North Carolina, United States
View Trial DetailsNCT03837379
Behavior, Behavioral Symptoms
Charleston, South Carolina, United States
View Trial Details