Anxiety DisordersNCT03918031

Personalized Feedback for Distress Intolerant Smokers

A study testing PFI for Smoking & Distress Tolerance and PFI for Smoking Only in people with Anxiety Disorders and Depression, run by University of Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders, Depression, Psychological Distress
What is being tested?: PFI for Smoking & Distress Tolerance and PFI for Smoking Only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2019to 24 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204

Other trials in United States

About this study

Read the 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.

Conditions: Anxiety Disorders, Depression, Psychological Distress, Tobacco Dependence, Smoking, Tobacco, Smoking, Cigarette
Being tested: PFI for Smoking & Distress Tolerance, PFI for Smoking Only
Keywords: Psychological Distress, Tobacco, Smoking, Feedback, Stress, Anxiety Disorders, Depression
Medical subject headings: Anxiety Disorders, Depression, Tobacco Use Disorder, Tobacco Smoking, Cigarette Smoking, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PFI for Smoking & Distress ToleranceBehavioural
Personalized Feedback Intervention for smoking and distress tolerance.
PFI for Smoking OnlyBehavioural
Personalized Feedback Intervention for smoking only (no distress tolerance component)

Study groups in NCT03918031
Study group	Role	What they receive
PFI for Smoking & Distress Tolerance	Active comparator	A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance. Receives: 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). Receives: Behavioral: PFI for Smoking Only

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 2-week, and 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201924 Oct 2021

First posted17 Apr 2019
Study start15 Jul 2019
Primary completion24 Oct 2021
Study completion24 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03918031
Sponsor's protocol ID: STUDY00000686
Other IDs: 1F31DA046127-01
Status last verified: Nov 2024
First submitted: 15 Feb 2019
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Feedback for Distress Intolerant Smokers
ClinicalTrials.gov ID: NCT03918031
Acronym / sponsor ID: STUDY00000686
Conditions: Anxiety Disorders, Depression, Psychological Distress, Tobacco Dependence, Smoking, Tobacco, Smoking, Cigarette
Keywords: Psychological Distress, Tobacco, Smoking, Feedback, Stress, Anxiety Disorders, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: University of HoustonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 15 Jul 2019 (actual)
Primary completion: 24 Oct 2021 (actual)
Study completion: 24 Oct 2021 (actual)
First posted: 17 Apr 2019 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
PFI for Smoking & Distress Tolerance	Active comparator	Behavioral: PFI for Smoking & Distress ToleranceA brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
PFI for Smoking Only	Active comparator	Behavioral: PFI for Smoking OnlyA brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PFI for Smoking & Distress TolerancePersonalized Feedback Intervention for smoking and distress tolerance.	Behavioural	PFI for Smoking & Distress Tolerance
PFI for Smoking OnlyPersonalized Feedback Intervention for smoking only (no distress tolerance component)	Behavioural	PFI for Smoking Only

Primary outcome

Rulers for Smoking Cessation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PFI for Smoking & Distress Tolerance	57	57
PFI for Smoking Only	64	64

Primary outcome: Rulers for Smoking Cessation

Time frame: Baseline, 2-week, and 1-month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	PFI for Smoking & Distress Tolerance n = 57	PFI for Smoking Only n = 64
Motivation to Quit: Baseline	7.37 (2.57)	7.89 (2.05)
Motivation to Quit: 2-Week Follow-up	8.58 (1.46)	8.40 (1.71)
Motivation to Quit: 1-Month Follow-up	8.39 (1.46)	7.98 (2.32)
Confidence to Quit: Baseline	6.09 (2.81)	6.48 (2.39)
Confidence to Quit: 2-Week Follow-up	8.09 (2.26)	7.78 (2.18)
Confidence to Quit: 1-Month Follow-up	8.02 (1.81)	7.73 (2.34)
Intention to Quit: Baseline	6.53 (2.87)	7.20 (2.61)
Intention to Quit: 2-Week Follow-up	7.98 (2.44)	7.95 (2.22)

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

Primary outcome: Barriers to Cessation Scale

Time frame: Baseline, 2-week, and 1-month follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	PFI for Smoking & Distress Tolerance n = 57	PFI for Smoking Only n = 64
Baseline	38.46 (8.20)	38.61 (9.01)
2-Week Follow-up	32.67 (9.95)	33.08 (11.09)
1-Month Follow-up	31.23 (9.90)	31.18 (12.13)

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

Primary outcome: Timeline Follow-Back

Time frame: Baseline, 2-week, and 1-month follow-up. Mean (Standard Deviation). Unit: cigarettes/day

Measure	PFI for Smoking & Distress Tolerance n = 57	PFI for Smoking Only n = 64
Baseline	8.26 (2.98)	8.64 (2.53)
2-Week Follow-up	4.19 (3.21)	4.26 (3.05)
1-Month Follow-up	3.12 (3.10)	3.06 (3.19)

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

Primary outcome: Distress Tolerance Scale

Time frame: Baseline, 2-week, and 1-month follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	PFI for Smoking & Distress Tolerance n = 57	PFI for Smoking Only n = 64
Baseline	1.69 (0.38)	1.75 (0.44)
2-Week Follow-up	2.51 (0.75)	2.57 (0.73)
1-Month Follow-up	2.76 (0.82)	2.72 (0.89)

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

Adverse events

Time frame: 1-month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PFI for Smoking & Distress Tolerance	0 of 57 (0%)	0 of 57 (0%)	0 of 57
PFI for Smoking Only	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Project WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brooke Kauffman, M.A. principal investigator

University of Houston

Michael Zvolensky, Ph.D. principal investigator

University of Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PFI for Smoking & Distress Tolerance and PFI for Smoking Only in people with Anxiety Disorders and Depression, run by University of Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rulers for Smoking Cessation (time frame: Baseline, 2-week, and 1-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.