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Completed

NCT Number: NCT03918031

Personalized Feedback for Distress Intolerant Smokers

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.

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Cigarette Smoking Depression Mental Disorders Psychological Distress Smoking Smoking, Cigarette Smoking, Tobacco Substance-Related Disorders Tobacco Dependence Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFI for Smoking & Distress Tolerance

Behavioral

Personalized Feedback Intervention for smoking and distress tolerance.

PFI for Smoking Only

Behavioral

Personalized Feedback Intervention for smoking only (no distress tolerance component)

Primary outcomes

  1. Rulers for Smoking Cessation

    Time frame: 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.

  2. Barriers to Cessation Scale

    Time frame: 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).

  3. Timeline Follow-Back

    Time frame: 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.

  4. Distress Tolerance Scale

    Time frame: 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).

  5. Mood and Anxiety Symptom Questionnaire-Short Form

    Time frame: 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).

  6. Self-Help Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2019
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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