Personalized Feedback for Distress Intolerant Smokers

Not Applicable

Completed

Conditions: Depression
Smoking, Tobacco
Anxiety Disorders
Psychological Distress
Tobacco Dependence
Smoking, Cigarette

Interventions: Behavioral: PFI for Smoking & Distress Tolerance
Behavioral: PFI for Smoking Only

Registration Number: NCT03918031

Lead Sponsor: University of Houston

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFI for Smoking & Distress Tolerance	PFI for Smoking & Distress Tolerance	A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only	PFI for Smoking Only	A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).

Primary Outcome Measures

Name	Time	Method
Rulers for Smoking Cessation	Baseline, 2-week, and 1-month follow-up	The Rulers for Smoking Cessation asks participants to rate three rulers associated with motivation, confidence, and intention to quit smoking. Motivation is indexed by, "How important is stopping smoking to you (0 = Not important at all; 10 = Most important goal of my life)?" with a higher score indicating a better outcome. Confidence is indexed by, "How confident are you that you will quit smoking within the next month (0 = Not at all; 10 = 100% confident)?" with a higher score indicating a better outcome. Intention is indexed by, "How ready are you to quit smoking within the next month (0 = Not at all; 10 = 100% ready)?" with a higher score indicating a better outcome.
Barriers to Cessation Scale	Baseline, 2-week, and 1-month follow-up	The Barriers to Cessation Scale assesses 19-barriers, or specific stressors, associated with smoking cessation. Participants indicate, according to a 4-point Likert-style scale (0 = Not a barrier to 3 = Large barrier), the extent to which they identify with each of the barriers to cessation. Lower scores indicate a better outcome (range = 0 - 57).
Timeline Follow-Back	Baseline, 2-week, and 1-month follow-up	The Timeline Follow-Back (TLFB) is a self-report measure to assess retrospective estimates of daily smoking. The TLFB was used to assess smoking rate computed as a mean score of past 7-day cigarettes smoked per day.
Distress Tolerance Scale	Baseline, 2-week, and 1-month follow-up	The Distress Tolerance Scale is a self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = 'strongly agree' to 5 = 'strongly disagree'), the extent to which they believe they can experience and withstand distressing emotional states. All items are averaged to create a total mean score ranging from 1 to 5 with higher total scores indicating a better outcome (i.e., greater tolerance for distress).
Mood and Anxiety Symptom Questionnaire-Short Form	Baseline, 2-week, and 1-month follow-up	The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items with lower scores indicating better outcomes (range = 22 - 110).
Self-Help Scale	Baseline, 2-week, and 1-month follow-up	The Self-Help Scale asks participants to indicate whether they would be willing to try each of 10 strategies to help deal with depression and anxiety on a 5-point Likert-type scale from 0 (definitely not) to 4 (extremely willing). Higher scores indicate a better outcome (range = 0 - 4).