- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918031
Personalized Feedback for Distress Intolerant Smokers
October 28, 2021 updated by: Brooke Kauffman, University of Houston
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
- Active Suicidality
- Psychosis
- Legal status that will interfere with participating
- Not being fluent in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: PFI for Smoking & Distress Tolerance
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
|
Personalized Feedback Intervention for smoking and distress tolerance.
|
ACTIVE_COMPARATOR: PFI for Smoking Only
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
|
Personalized Feedback Intervention for smoking only (no distress tolerance component)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rulers for Smoking Cessation
Time Frame: Assess change from baseline to 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.
|
Assess change from baseline to 2-week and 1-month follow-up
|
Barriers to Cessation Scale
Time Frame: Assess change from baseline to 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).
|
Assess change from baseline to 2-week and 1-month follow-up
|
Smoking History Questionnaire
Time Frame: Assess change from baseline to 2-week and 1-month follow-up
|
The Smoking History Questionnaire is a self-report questionnaire used that will be used to assess smoking rate and number of quit attempts.
This measure contains 30 items including open ended formats in which the individual will self-report their smoking rate per day and number of previous quit attempts.
Lower reported smoking rate indicates a better outcome.
Higher reported number of quit attempts indicates a better outcome.
|
Assess change from baseline to 2-week and 1-month follow-up
|
Distress Tolerance Scale
Time Frame: Assess change from baseline to 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.
|
Assess change from baseline to 2-week and 1-month follow-up
|
Mood and Anxiety Symptom Questionnaire-Short Form
Time Frame: Assess change from baseline to 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).
|
Assess change from baseline to 2-week and 1-month follow-up
|
Self-Help Scale
Time Frame: Assess change from baseline to 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 - 40).
|
Assess change from baseline to 2-week and 1-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brooke Kauffman, M.A., University of Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 15, 2019
Primary Completion (ACTUAL)
October 24, 2021
Study Completion (ACTUAL)
October 24, 2021
Study Registration Dates
First Submitted
February 15, 2019
First Submitted That Met QC Criteria
April 13, 2019
First Posted (ACTUAL)
April 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 28, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000686
- 1F31DA046127-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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