Clinical trial NCT03382093: Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Official title: Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Anxiety
Tobacco Dependence
Smoking, Cigarette
Smoking, Tobacco
Keywords: Anxiety Sensitivity
Tobacco
Smoking
Anxiety
Feedback
Stress
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-12-22
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.
Primary purpose: TREATMENT

Brief summary: This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.

Detailed description: The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Eligibility criteria: Inclusion Criteria:

* Elevated anxiety sensitivity defined as an ASI-III score of at least 17
* Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 4 ppm)
* Not presently engaged in a quit attempt
* Not currently engaged in mental health treatment
* Capable of providing informed consent
* Willing to attend all study visits and comply with the protocol

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Students for whom you have direct access to/influence on grades
* Use of other tobacco products
* Currently suicidal or high suicide risk
* Currently psychotic or high psychotic risk
* Insufficient command of English to participate in assessment or treatment

Primary outcomes:
measure: Evaluate PFI
timeFrame: Assessed at 1-month follow-up after the one-session intervention
Secondary outcomes:
measure: Smoking Motivational Processes
timeFrame: Assessed at 1-month follow-up after the one-session intervention
measure: Smoking Behavior
timeFrame: Assessed at 1-month follow-up after the one-session intervention
measure: Affective Processes
timeFrame: Assessed at 1-month follow-up after the one-session intervention
measure: Mechanisms
timeFrame: Assessed at 1-month follow-up after the one-session intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Lorra L. Garey, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Michael J. Zvolensky, PHD
role: PRINCIPAL_INVESTIGATOR
References: