Smoking Cessation
Conditions
Keywords
Nicotine Dependence, applied behavioral research
Brief summary
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
Detailed description
Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse prevention strategies, and discuss barriers to cessation, previous quit attempts, risky situations, and benefits observed after quitting. Participants may also complete exercises designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support. Objective 2: To examine the rates of smoking abstinence across intervention formats. Investigators will attempt to follow-up with participants for a 6-months after program completion. Investigators will assess point prevalence abstinence for each intervention delivery method. Objective 3: To assess individual difference variables that influence outcomes. Investigators will examine individual-difference predictors of outcomes, such as readiness to quit, social support, distress, and environmental factors.
Interventions
BEHAVIORALGroup Counseling
8 sessions over 4 weeks. Lasting 1-2 hours each
BEHAVIORALIndividual Counseling
8 in person sessions over 4 weeks. Lasting 30-45 minutes each
BEHAVIORALPhone Counseling
8 phone sessions over 4 weeks. Lasting 30-45 minutes each
BEHAVIORALVideo Counseling
8 video call sessions over 4 weeks. Lasting 30-45 minutes each
BEHAVIORALTexting support
Texts with smoking cessation support throughout the program
DRUGNicotine Replacement Therapy
Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm) * Able to speak and read English * Able to engage using at least one of the intervention formats.
Exclusion criteria
* Enrollment in another cessation program * Do not speak and read English * Do not have access to at least one intervention format * Have contraindications for NRT * Do not have contact information (e.g., address, telephone number) * Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse) * They endorse active addiction to another substance (e.g., illicit drugs or alcohol). * People who self-report having a severe mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of 24 hour smoking abstinence across intervention | Up to 24 hours after session 1 | Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of 28-day smoking abstinence across intervention | Up to 28 days after session 1 | Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking) |
| Average intervention rating | Up to 4 weeks after session 1 | Scaled survey will be used to assess the quality and the content of the intervention \[i.e., the extent to which the content was informative, encouraging, attention capturing, credible, applicable to their lives, and comprehensible.\] |
| Rate of 7-day smoking abstinence across intervention | Up to 7 days after session 1 | Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking) |
| Study Retention | Up to 4 weeks after session 1 | — |
| Nicotine Replacement Therapy (NRT) Completed | Up to 4 weeks after session 1 | Average count of doses of NRT taken by participants |
| Sessions completed | Up to 4 weeks after session 1 | Average count of sessions each participant completed (1-8) |
Countries
United States
Outcome results
None listed