An interventional study of Personalized Feedback Intervention and Smoking Information Control in Anxiety Disorders, Anxiety and Tobacco Dependence, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
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Among 11 studies in Anxiety Disorders by University of Houston — 1 open to participants now, 1 under way, none of them phase 3. Anxiety Disorders · University of Houston.
Among the 11 studies in Anxiety Disorders by University of Houston, this one is the 7th largest by enrollment, is the only one that started in 2017, is one of 9 with no phase, and was the 4th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →1 of the 11 studies in Anxiety Disorders by University of Houston is open now, in 1 country. Recruiting first, the newest first:
University of Houston · Sites in United States
Ages 21+
By country, each count listing its studies:
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
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11 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2017.
This study's enrollment of 95 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 102 across the 11 interventional studies. Of the 10 that completed or were terminated, 3 (30%) have results posted.
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University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Anxiety Disorders by University of Houston, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Personalized Feedback Intervention
Standard, computer-delivered smoking cessation treatment/information.
Behavioral: Smoking Information Control
Personalized Feedback Intervention for smoking and anxiety.
Also known as: PFI
Smoking Information with no personalized feedback.
Also known as: Control, Clearing the Air Pamphlet
Evaluate PFI
Evaluate the protocol for a brief personalized, computer-delivered intervention. Assessed by program evaluation survey.
Time frame: Assessed at 1-month follow-up after the one-session intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at 1-month follow-up after the one-session intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2017 to primary completion in Jun 2019, 21 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 21 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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