Clinical trial NCT03918031: Personalized Feedback for Distress Intolerant Smokers
Official title: Personalized Feedback for Distress Intolerant Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Psychological Distress
Tobacco Dependence
Smoking, Tobacco
Smoking, Cigarette
Keywords: Psychological Distress
Tobacco
Smoking
Feedback
Stress
Anxiety Disorders
Depression
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-04-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
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 one-session computer-delivered intervention: either (1) personalized feedback intervention on ability to handle discomfort and smoking or (2) personalized feedback intervention on smoking only.
Primary purpose: TREATMENT

Brief summary: This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and distress tolerance. The PFI will focus on feedback about smoking behavior, distress tolerance, 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 distress tolerance to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, increase distress tolerance, reduce anxiety/depressive symptoms, and increase adaptive coping skills compared to a personalized feedback on smoking only control. To address this aim, the investigators will implement a randomized controlled trial that will employ a longitudinal experimental design and involve four 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 (Active PFI versus Control PFI with no personalized feedback on distress tolerance), and a post-intervention assessment; (c) 2-week follow-up; (d) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Eligibility criteria: Inclusion Criteria:

* Low distress tolerance defined as a DTS mean score of 2.56 or lower
* Daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 5 ppm)

Exclusion Criteria:

* Currently engaging in treatment for an alcohol/drug problem including smoking cessation
* Legal status that will interfere with participating
* Not being fluent in English

Primary outcomes:
measure: Rulers for Smoking Cessation
timeFrame: Baseline, 2-week, and 1-month follow-up
measure: Barriers to Cessation Scale
timeFrame: Baseline, 2-week, and 1-month follow-up
measure: Timeline Follow-Back
timeFrame: Baseline, 2-week, and 1-month follow-up
measure: Distress Tolerance Scale
timeFrame: Baseline, 2-week, and 1-month follow-up
measure: Mood and Anxiety Symptom Questionnaire-Short Form
timeFrame: Baseline, 2-week, and 1-month follow-up
measure: Self-Help Scale
timeFrame: Baseline, 2-week, and 1-month follow-up
Secondary outcomes:
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: Brooke Kauffman, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Michael Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: