Personalized Feedback for Distress Intolerant Smokers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03918031

Enrollment

121

Registered

2019-04-17

Start date

2019-07-15

Completion date

2021-10-24

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

BEHAVIORALPFI for Smoking & Distress Tolerance

Personalized Feedback Intervention for smoking and distress tolerance.

BEHAVIORALPFI for Smoking Only

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Rulers for Smoking Cessation	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.
Barriers to Cessation Scale	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).
Timeline Follow-Back	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.
Distress Tolerance Scale	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).
Mood and Anxiety Symptom Questionnaire-Short Form	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).
Self-Help Scale	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
PFI for Smoking & Distress Tolerance A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.	57
PFI for Smoking Only A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).	64
Total	121

Baseline characteristics

Characteristic	PFI for Smoking & Distress Tolerance	PFI for Smoking Only	Total
Age, Continuous	28.60 years STANDARD_DEVIATION 5.35	29.98 years STANDARD_DEVIATION 9.01	29.33 years STANDARD_DEVIATION 7.51
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Asian	0 Participants	5 Participants	5 Participants
Race (NIH/OMB) Black or African American	17 Participants	23 Participants	40 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	39 Participants	32 Participants	71 Participants
Region of Enrollment United States	57 Participants	64 Participants	121 Participants
Sex: Female, Male Female	18 Participants	17 Participants	35 Participants
Sex: Female, Male Male	39 Participants	47 Participants	86 Participants
Timeline Follow-Back	8.26 cigarettes/day STANDARD_DEVIATION 2.98	8.64 cigarettes/day STANDARD_DEVIATION 2.53	8.46 cigarettes/day STANDARD_DEVIATION 2.75

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 57	0 / 64
other Total, other adverse events	0 / 57	0 / 64
serious Total, serious adverse events	0 / 57	0 / 64

Outcome results

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).

Time frame: Baseline, 2-week, and 1-month follow-up