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

University of Houston

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Device: Nicotine Patch; Behavioral: Standard Therapy; Behavioral: UP-ST Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03920137

STUDY00000859

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Active- UP-ST

Active Comparator group

Description:

The intervention will be the UP-ST therapy sessions. Treatment will be delivered using the new UP-ST protocol that will be developed in Phase I by integrating components of smoking cessation treatments (e.g. using the nicotine patch) with the theoretical model and treatment components of the existing UP treatment protocol, which includes both a therapist14 and patient12 manual. The UP-ST will maintain the same focus on transdiagnostic mechanisms of change as in the original UP, but will be adapted to integrate the smoking cessation focus and concurrent use of NRT. Thus, the investigators can successfully adapt and develop the new UP-ST to be delivered in eight 90-minute sessions and will be able to incorporate content from each of the 8 modules of the UP in the new UP-ST protocol.

Treatment:

Device: Nicotine Patch

Behavioral: UP-ST Therapy

Control- Standard

Experimental group

Description:

The Intervention will be the standard therapy sessions. Participants will receive a standard smoking cessation treatment based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence19. The investigative team has considerable expertise in developing and evaluating behavioral and pharmacological treatments for smoking cessation. Treatment will be delivered in eight, 90-minute sessions over an eight-week period.

Treatment:

Behavioral: Standard Therapy