Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers

Not Applicable

Recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT03920137
• Lead Sponsor: University of Houston

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2020-12-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-07-26
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Inclusion criteria for the study include 1) being 18-65 years of age, 2) daily smoking of at least 5 cigarettes per day for at least one year and biochemically confirmed at least 10 ppm at baseline. Participants must be 3) motivated to quit smoking in the next month 4) have clinically significant anxiety or depression defined as >=8 on the OASIS or ODIS, 5) must be willing and able to attend all the appointments, and 6) must be willing to quit smoking as the sixth treatment session.

Exclusion Criteria

• Exclusion criteria include 1) Use of other tobacco products 2) Report of current or intended participation in a concurrent substance abuse treatment, 3) Ongoing psychotherapy of any duration targeting anxiety or depression, 4) Current non-nicotine substance dependence, 5) Not being fluent in English, 6) Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers, 7) Legal status that will interfere with participation, 8) Positive pregnancy test at baseline, 9) Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short- and long-term point prevalence abstinence (PPA).	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Tobacco craving	12 months	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.
Tobacco withdrawal	12 months	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 to first smoking lapse and time to relapse	12 months	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.
Tobacco dependence	12 months	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.

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States