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Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03382093
Enrollment
95
Registered
2017-12-22
Start date
2017-08-23
Completion date
2019-06-01
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Anxiety, Tobacco Dependence, Smoking, Cigarette, Smoking, Tobacco

Keywords

Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress

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.

Interventions

Personalized Feedback Intervention for smoking and anxiety.

BEHAVIORALSmoking Information Control

Smoking Information with no personalized feedback.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate PFIAssessed at 1-month follow-up after the one-session interventionEvaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.

Secondary

MeasureTime frameDescription
Smoking Motivational ProcessesAssessed at 1-month follow-up after the one-session interventionSmokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure.
Smoking BehaviorAssessed at 1-month follow-up after the one-session interventionSmokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide \[CO\] analysis.
Affective ProcessesAssessed at 1-month follow-up after the one-session interventionSmokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.
MechanismsAssessed at 1-month follow-up after the one-session interventionSmokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026