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| ID | Type | Description | Link |
|---|---|---|---|
| 1F31DA046127-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFI for Smoking & Distress Tolerance | Active Comparator | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFI for Smoking & Distress Tolerance | Behavioral | Personalized Feedback Intervention for smoking and distress tolerance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brooke Kauffman, M.A. | University of Houston | Principal Investigator |
| Michael Zvolensky, Ph.D. | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston | Houston | Texas | 77204 | United States |
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| Label | URL |
|---|---|
| Project Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PFI for Smoking & Distress Tolerance | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance. |
| FG001 | PFI for Smoking Only | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PFI for Smoking & Distress Tolerance | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance. |
| BG001 | PFI for Smoking Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2-week, and 1-month follow-up |
|
1-month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PFI for Smoking & Distress Tolerance | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brooke Kauffman | University of Houston | (713) 743-8056 | byredmond@central.uh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2019 | Aug 1, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D014029 | Tobacco Use Disorder |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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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.
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| PFI for Smoking Only | Behavioral | Personalized Feedback Intervention for smoking only (no distress tolerance component) |
|
| 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 |
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Timeline Follow-Back | Mean | Standard Deviation | cigarettes/day |
|
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance. |
| OG001 | PFI for Smoking Only | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component). |
|
|
| Primary | 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). | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-week, and 1-month follow-up |
|
|
|
| Primary | 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. | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | cigarettes/day | Baseline, 2-week, and 1-month follow-up |
|
|
|
| Primary | 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). | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-week, and 1-month follow-up |
|
|
|
| Primary | 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). | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-week, and 1-month follow-up |
|
|
|
| Primary | 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). | Overall number is different from analyzed number due to participants not completing select follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-week, and 1-month follow-up |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | PFI for Smoking Only | A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component). | 0 | 64 | 0 | 64 | 0 | 64 |
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| D064419 |
| Chemically-Induced Disorders |
| D064424 | Tobacco Use |
| 2-Week Follow-up |
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| 1-Month Follow-up |
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| 2-Week Follow-up |
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| 1-Month Follow-up |
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| 2-Week Follow-up |
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| 1-Month Follow-up |
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| Anxiety: 2-Week Follow-up |
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| Anxiety: 4-Week Follow-up |
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| Depression: Baseline |
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| Depression: 2-Week Follow-up |
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| Depression: 4-Week Follow-up |
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| 2-Week Follow-up |
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| 1-Month Follow-up |
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