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

NCT03920137 | Unknown DMC

• 1 other identifier: STUDY00000859
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Short- 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.

  12 months

Secondary Outcomes (4)

• Tobacco withdrawal

  12 months

• Time to first smoking lapse and time to relapse

  12 months

• Tobacco craving

  12 months

• Tobacco dependence

  12 months

Study Arms (2)

Active- UP-ST

ACTIVE COMPARATOR

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.

Behavioral: UP-ST Therapy; Device: Nicotine Patch

Control- Standard

EXPERIMENTAL

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.

Behavioral: Standard Therapy

Interventions

UP-ST Therapy BEHAVIORAL

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

Active- UP-ST

Standard Therapy BEHAVIORAL

In the control group therapists will hold standard smoking cessation therapy sessions.

Control- Standard

Nicotine Patch DEVICE

Nicotine patches will be worn in tandem with UP-ST therapy

Active- UP-ST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

RECRUITING

Related Publications (2)

• Zvolensky MJ, Jardin C, Wall MM, Gbedemah M, Hasin D, Shankman SA, Gallagher MW, Bakhshaie J, Goodwin RD. Psychological Distress Among Smokers in the United States: 2008-2014. Nicotine Tob Res. 2018 May 3;20(6):707-713. doi: 10.1093/ntr/ntx099.

  PMID: 28482108 BACKGROUND

• National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/

  PMID: 24455788 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics

Study Officials

• Michael Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

• Matthew Gallagher, Ph.D.

  University of Houston

  STUDY DIRECTOR

Central Study Contacts

Pam Nizio, B.S.

CONTACT

713-743-8056; HoustonAHRL@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 18, 2019
• Study Start: December 20, 2020
• Primary Completion: July 26, 2023
• Study Completion: February 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)