This study will look at the effectiveness of a new treatment protocol for anxious and depressed smokers. Participants with clinically significant anxiety or depression will receive either the standard smoking cessation treatment or the Unified Protocol for Smoking Cessation Treatment. This study will demonstrate that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.
The present proposal aims to develop a new and efficient treatment for smokers with clinically significant anxiety or depression. In Phase I, the investigators will complete the development of a new treatment protocol (Unified Protocol for Smoking Cessation Treatment; UP-ST) that integrates current best practices of cognitive behavioral smoking cessation treatments and nicotine replacement therapy with the recently developed UP treatment protocol that has been shown to effectively treat both anxiety disorders and depression and to impact specific mechanisms (e.g., neuroticism) that are relevant to both smoking and anxiety/depression remission. In Phase II, 60 smokers with clinically significant anxiety or depression will be recruited and randomly assigned to either: (1) the UP-ST or (2) standard smoking cessation treatment (ST) based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services. The investigators will examine the UP-ST relative to ST on smoking, anxiety/depression, and mechanisms of change. Demonstrating that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Phase 1 analyses will focus primarily on demonstrating feasibility and utility of the new UP-ST intervention. Feasibility will be determined by examining the proportion of individuals who 1) complete each module of the UP-ST treatment, 2) complete a full course of the UP-ST treatment, and by 3) benchmarking participant ratings of treatment credibility, expectancy, and satisfaction with corresponding ratings from our previous clinical trials examining the UP or ST interventions. The investigators will include and examine outcomes on the same measures that will be used in phase 2, but due to the sample size our analyses for Phase 1 will focus on intraindividual effect sizes (with 95% CI) for continuous smoking, anxiety, and depression outcomes
In the control group therapists will hold standard smoking cessation therapy sessions.
University of Houston
Houston, Texas, United States
RECRUITINGShort- and long-term point prevalence abstinence (PPA).
In three separate follow up appointments, one 3 months after the end of treatments, one 6 months after and one 12 months after, The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days. The investigators expect that point prevalence abstinence will be higher, both in the short term and long term, in the UP-ST condition than in the ST condition. Similarly, The investigators expect the rate of decline in abstinence over time to be shallower (smaller) in UP-ST than in ST.
Time frame: 12 months
Tobacco withdrawal
In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess withdrawal symptoms. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points.
Time frame: 12 months
Time to first smoking lapse and time to relapse
The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse. The investigators will take an average for control and active participants and The investigators expect mean time to first lapse and to relapse to be greater for those in the UP-ST compared to those in the ST condition.
Time frame: 12 months
Tobacco craving
In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess tobacco craving. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points.
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Nicotine patches will be worn in tandem with UP-ST therapy
Time frame: 12 months
Tobacco dependence
In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess tobacco dependence. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points.
Time frame: 12 months