Trial Outcomes & Findings for Personalized Feedback for Distress Intolerant Smokers (NCT NCT03918031)

NCT ID: NCT03918031

Last Updated: 2024-11-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

121 participants

Primary outcome timeframe

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

Results posted on

2024-11-15

Participant Flow

Participant milestones

Participant milestones
Measure
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
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Overall Study
STARTED
57
64
Overall Study
Post-Intervention
57
64
Overall Study
2-Week Follow-up
57
60
Overall Study
1-Month Follow-up
56
62
Overall Study
COMPLETED
57
64
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Feedback for Distress Intolerant Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Total
n=121 Participants
Total of all reporting groups
Age, Continuous
28.60 years
STANDARD_DEVIATION 5.35 • n=99 Participants
29.98 years
STANDARD_DEVIATION 9.01 • n=107 Participants
29.33 years
STANDARD_DEVIATION 7.51 • n=206 Participants
Sex: Female, Male
Female
18 Participants
n=99 Participants
17 Participants
n=107 Participants
35 Participants
n=206 Participants
Sex: Female, Male
Male
39 Participants
n=99 Participants
47 Participants
n=107 Participants
86 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
5 Participants
n=107 Participants
5 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=99 Participants
23 Participants
n=107 Participants
40 Participants
n=206 Participants
Race (NIH/OMB)
White
39 Participants
n=99 Participants
32 Participants
n=107 Participants
71 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
57 Participants
n=99 Participants
64 Participants
n=107 Participants
121 Participants
n=206 Participants
Timeline Follow-Back
8.26 cigarettes/day
STANDARD_DEVIATION 2.98 • n=99 Participants
8.64 cigarettes/day
STANDARD_DEVIATION 2.53 • n=107 Participants
8.46 cigarettes/day
STANDARD_DEVIATION 2.75 • n=206 Participants

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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.

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Rulers for Smoking Cessation
Motivation to Quit: Baseline
7.37 units on a scale
Standard Deviation 2.57
7.89 units on a scale
Standard Deviation 2.05
Rulers for Smoking Cessation
Motivation to Quit: 2-Week Follow-up
8.58 units on a scale
Standard Deviation 1.46
8.40 units on a scale
Standard Deviation 1.71
Rulers for Smoking Cessation
Motivation to Quit: 1-Month Follow-up
8.39 units on a scale
Standard Deviation 1.46
7.98 units on a scale
Standard Deviation 2.32
Rulers for Smoking Cessation
Confidence to Quit: Baseline
6.09 units on a scale
Standard Deviation 2.81
6.48 units on a scale
Standard Deviation 2.39
Rulers for Smoking Cessation
Confidence to Quit: 2-Week Follow-up
8.09 units on a scale
Standard Deviation 2.26
7.78 units on a scale
Standard Deviation 2.18
Rulers for Smoking Cessation
Confidence to Quit: 1-Month Follow-up
8.02 units on a scale
Standard Deviation 1.81
7.73 units on a scale
Standard Deviation 2.34
Rulers for Smoking Cessation
Intention to Quit: Baseline
6.53 units on a scale
Standard Deviation 2.87
7.20 units on a scale
Standard Deviation 2.61
Rulers for Smoking Cessation
Intention to Quit: 2-Week Follow-up
7.98 units on a scale
Standard Deviation 2.44
7.95 units on a scale
Standard Deviation 2.22
Rulers for Smoking Cessation
Intention to Quit: 1-Month Follow-up
8.34 units on a scale
Standard Deviation 1.54
7.66 units on a scale
Standard Deviation 2.52

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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).

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Barriers to Cessation Scale
Baseline
38.46 score on a scale
Standard Deviation 8.20
38.61 score on a scale
Standard Deviation 9.01
Barriers to Cessation Scale
2-Week Follow-up
32.67 score on a scale
Standard Deviation 9.95
33.08 score on a scale
Standard Deviation 11.09
Barriers to Cessation Scale
1-Month Follow-up
31.23 score on a scale
Standard Deviation 9.90
31.18 score on a scale
Standard Deviation 12.13

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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.

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Timeline Follow-Back
Baseline
8.26 cigarettes/day
Standard Deviation 2.98
8.64 cigarettes/day
Standard Deviation 2.53
Timeline Follow-Back
2-Week Follow-up
4.19 cigarettes/day
Standard Deviation 3.21
4.26 cigarettes/day
Standard Deviation 3.05
Timeline Follow-Back
1-Month Follow-up
3.12 cigarettes/day
Standard Deviation 3.10
3.06 cigarettes/day
Standard Deviation 3.19

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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).

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Distress Tolerance Scale
Baseline
1.69 score on a scale
Standard Deviation 0.38
1.75 score on a scale
Standard Deviation 0.44
Distress Tolerance Scale
2-Week Follow-up
2.51 score on a scale
Standard Deviation 0.75
2.57 score on a scale
Standard Deviation 0.73
Distress Tolerance Scale
1-Month Follow-up
2.76 score on a scale
Standard Deviation 0.82
2.72 score on a scale
Standard Deviation 0.89

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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).

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Mood and Anxiety Symptom Questionnaire-Short Form
Anxiety: Baseline
54.14 score on a scale
Standard Deviation 18.73
51.40 score on a scale
Standard Deviation 19.51
Mood and Anxiety Symptom Questionnaire-Short Form
Anxiety: 2-Week Follow-up
44.12 score on a scale
Standard Deviation 17.80
43.07 score on a scale
Standard Deviation 19.18
Mood and Anxiety Symptom Questionnaire-Short Form
Anxiety: 4-Week Follow-up
41.75 score on a scale
Standard Deviation 18.78
42.55 score on a scale
Standard Deviation 20.35
Mood and Anxiety Symptom Questionnaire-Short Form
Depression: Baseline
71.26 score on a scale
Standard Deviation 14.67
70.05 score on a scale
Standard Deviation 12.29
Mood and Anxiety Symptom Questionnaire-Short Form
Depression: 2-Week Follow-up
62.30 score on a scale
Standard Deviation 9.89
60.97 score on a scale
Standard Deviation 14.50
Mood and Anxiety Symptom Questionnaire-Short Form
Depression: 4-Week Follow-up
58.18 score on a scale
Standard Deviation 12.33
59.74 score on a scale
Standard Deviation 15.33

PRIMARY outcome

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

Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.

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).

Outcome measures

Outcome measures
Measure
PFI for Smoking & Distress Tolerance
n=57 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only
n=64 Participants
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Self-Help Scale
Baseline
3.00 score on a scale
Standard Deviation 0.76
3.00 score on a scale
Standard Deviation 0.72
Self-Help Scale
2-Week Follow-up
3.09 score on a scale
Standard Deviation 0.76
2.96 score on a scale
Standard Deviation 0.77
Self-Help Scale
1-Month Follow-up
3.23 score on a scale
Standard Deviation 0.66
3.01 score on a scale
Standard Deviation 0.72

Adverse Events

PFI for Smoking & Distress Tolerance

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PFI for Smoking Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brooke Kauffman

University of Houston

Phone: (713) 743-8056

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place