Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Anxiety Clinical Trial

Official title:

Personalized Feedback for Smokers With Elevated Anxiety Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382093
• Other study ID #: CR00000267
• Secondary ID: 5F31DA043390-02
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hypersensitivity
• Smoking, Cigarette
• Smoking, Tobacco
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Personalized Feedback Intervention
Personalized Feedback Intervention for smoking and anxiety.
• Smoking Information Control
Smoking Information with no personalized feedback.

Locations

Country	Name	City	State
United States	Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate PFI	Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.	Assessed at 1-month follow-up after the one-session intervention
Secondary	Smoking Motivational Processes	Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure.	Assessed at 1-month follow-up after the one-session intervention
Secondary	Smoking Behavior	Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis.	Assessed at 1-month follow-up after the one-session intervention
Secondary	Affective Processes	Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.	Assessed at 1-month follow-up after the one-session intervention
Secondary	Mechanisms	Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.	Assessed at 1-month follow-up after the one-session intervention

External Links

•   Project Website