Anxiety DisordersNCT03382093
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
A study testing Personalized Feedback Intervention in people with Anxiety Disorders and Anxiety, run by University of Houston at 1 site in United States.
Trial summary
This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Anxiety, Tobacco Dependence
- What is being tested?
- Personalized Feedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elevated anxiety sensitivity defined as an ASI-III score of at least 17
- Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 4 ppm)
- Not presently engaged in a quit attempt
- Not currently engaged in mental health treatment
- Capable of providing informed consent
- Willing to attend all study visits and comply with the protocol
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Students for whom you have direct access to/influence on grades
- Use of other tobacco products
Show all 9Show fewer
- Currently suicidal or high suicide risk
- Currently psychotic or high psychotic risk
- Insufficient command of English to participate in assessment or treatment
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
About this study
This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, and adaptive coping strategies.
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 anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three 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 (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.
- Being tested
- Personalized Feedback Intervention, Smoking Information Control
- Keywords
- Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress
- Medical subject headings
- Anxiety Disorders, Tobacco Use Disorder, Cigarette Smoking, Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback InterventionBehavioural
Also called PFI
Personalized Feedback Intervention for smoking and anxiety.
Smoking Information ControlBehavioural
Also called Control, Clearing the Air Pamphlet
Smoking Information with no personalized feedback.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Feedback Intervention | Active comparator | A brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills. Receives: Behavioral: Personalized Feedback Intervention |
| Smoking Information Control | Active comparator | Standard, computer-delivered smoking cessation treatment/information. Receives: Behavioral: Smoking Information Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate PFI
Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.
Measured: Assessed at 1-month follow-up after the one-session intervention
Secondary outcomes (4)
Smoking Motivational Processes
Smokers in intervention, relative to a smoking information control, will report increased motivation and confidence for quitting smoking. Assessed using Smoking Rulers for Change measure.
Measured: Assessed at 1-month follow-up after the one-session intervention
Smoking Behavior
Smokers in intervention, relative to a smoking information control, will report reduced smoking rates. Assessed using Carbon Monoxide [CO] analysis.
Measured: Assessed at 1-month follow-up after the one-session intervention
Affective Processes
Smokers in intervention, relative to a smoking information control, will report greater reductions in anxiety sensitivity. Assessed using Anxiety Sensitivity Index measure.
Measured: Assessed at 1-month follow-up after the one-session intervention
Mechanisms
Smokers in the intervention, relative to the smoking information control, will report decreased positive consequences for continued smoking. Assessed using Smoking Consequence Questionnaire.
Measured: Assessed at 1-month follow-up after the one-session intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start23 Aug 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
- Investigators
- Lorra L. Garey, MA, Principal investigator, University of HoustonMichael J. Zvolensky, PHD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382093
- Sponsor's protocol ID
- CR00000267
- Other IDs
- 5F31DA043390-02
- Status last verified
- Jun 2019
- First submitted
- 27 Nov 2017
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT03382093
- Acronym / sponsor ID
- CR00000267
- Keywords
- Anxiety Sensitivity, Tobacco, Smoking, Anxiety, Feedback, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will focus on feedback about smoking behavior, AS, 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 anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills compared to a smoking information only control. To address this aim, we will implement a randomized controlled trial that will employ a longitudinal experimental design and involve three 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 (PFI versus smoking information control with no personalized feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.
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 computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.
| Arm | Type | Receives |
|---|---|---|
| Personalized Feedback Intervention | Active comparator | Behavioral: Personalized Feedback InterventionA brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills. |
| Smoking Information Control | Active comparator | Behavioral: Smoking Information ControlStandard, computer-delivered smoking cessation treatment/information. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elevated anxiety sensitivity defined as an ASI-III score of at least 17
- Daily smoking for at least one year (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 4 ppm)
- Not presently engaged in a quit attempt
- Not currently engaged in mental health treatment
- Capable of providing informed consent
Key exclusion criteria (9 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Students for whom you have direct access to/influence on grades
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 |
|---|---|---|
| Personalized Feedback InterventionAlso: PFIPersonalized Feedback Intervention for smoking and anxiety. | Behavioural | Personalized Feedback Intervention |
| Smoking Information ControlAlso: Control, Clearing the Air PamphletSmoking Information with no personalized feedback. | Behavioural | Smoking Information Control |
Primary outcome
Evaluate PFI
Time frame: Assessed at 1-month follow-up after the one-session intervention
Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.
4 secondary outcomes
Smoking Motivational Processes
Time frame: Assessed at 1-month follow-up after the one-session intervention
Smoking Behavior
Time frame: Assessed at 1-month follow-up after the one-session intervention
Affective Processes
Time frame: Assessed at 1-month follow-up after the one-session intervention
Mechanisms
Time frame: Assessed at 1-month follow-up after the one-session intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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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.
Lorra L. Garey, MA principal investigator
University of Houston
Michael J. Zvolensky, PHD 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 Personalized Feedback Intervention in people with Anxiety Disorders and Anxiety, 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 6 inclusion and 9 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 19 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate PFI (time frame: Assessed at 1-month follow-up after the one-session intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.