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

NCT03920137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Houston

    lead OTHER

Principal Investigators

  • Michael Zvolensky, Ph.D. · University of Houston

  • Matthew Gallagher, Ph.D. · University of Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-20
Primary Completion
2023-07-26
Completion
2024-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920137 on ClinicalTrials.gov