NCT03920137

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	UP-ST Therapy	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
BEHAVIORAL	Standard Therapy	In the control group therapists will hold standard smoking cessation therapy sessions.
DEVICE	Nicotine Patch	Nicotine patches will be worn in tandem with UP-ST therapy

Timeline

• Start date: 2020-12-20
• Primary completion: 2023-07-26
• Completion: 2024-02-01
• First posted: 2019-04-18
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States