Personalized Feedback for Distress Intolerant Smokers

NCT03918031 | Completed Results DMC

• 2 other identifiers: STUDY000006861F31DA046127-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression; Psychological Distress; Tobacco Dependence; Smoking, Tobacco; Smoking, Cigarette

Keywords

Psychological Distress; Tobacco; Smoking; Feedback; Stress; Anxiety Disorders; Depression

Outcome Measures

Primary Outcomes (6)

• Rulers for Smoking Cessation

  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.

  Baseline, 2-week, and 1-month follow-up

• Barriers to Cessation Scale

  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).

  Baseline, 2-week, and 1-month follow-up

• Timeline Follow-Back

  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.

  Baseline, 2-week, and 1-month follow-up

• Distress Tolerance Scale

  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).

  Baseline, 2-week, and 1-month follow-up

• Mood and Anxiety Symptom Questionnaire-Short Form

  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).

  Baseline, 2-week, and 1-month follow-up

• Self-Help Scale

  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).

  Baseline, 2-week, and 1-month follow-up

Study Arms (2)

PFI for Smoking & Distress Tolerance

ACTIVE COMPARATOR

A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.

Behavioral: PFI for Smoking & Distress Tolerance

PFI for Smoking Only

ACTIVE COMPARATOR

A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).

Behavioral: PFI for Smoking Only

Interventions

PFI for Smoking & Distress Tolerance BEHAVIORAL

Personalized Feedback Intervention for smoking and distress tolerance.

PFI for Smoking & Distress Tolerance

PFI for Smoking Only BEHAVIORAL

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

PFI for Smoking Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77204, United States

Location

Related Links

• Project Website

MeSH Terms

Conditions

Anxiety Disorders; Depression; Tobacco Use Disorder; Tobacco Smoking; Cigarette Smoking; Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Brooke Kauffman
• Organization: University of Houston

byredmond@central.uh.edu

(713) 743-8056

Study Officials

• Brooke Kauffman, M.A.

  University of Houston

  PRINCIPAL INVESTIGATOR

• Michael Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: April 17, 2019
• Study Start: July 15, 2019
• Primary Completion: October 24, 2021
• Study Completion: October 24, 2021
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)