Smoking Clinical Trial - Message Framing for Telephone Quitline Callers

Status Completed

Clinical Trial Summary

The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.

Clinical Trial Description

This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions. Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered. Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00589277
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2007
Completion date	May 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT02649556` - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2	N/A
Completed	`NCT03901066` - Smoking Dependence and Periodontitis
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT03170752` - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)	N/A
Completed	`NCT03305978` - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.	N/A
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT06105424` - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability	N/A
Active, not recruiting	`NCT02752022` - Monitoring the Transition From Smoking to E-cigarettes
Completed	`NCT02912000` - TEACH: Technology Evaluation to Address Child Health	N/A
Completed	`NCT02901171` - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT04340830` - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants	N/A
Completed	`NCT02949648` - Electronic Cigarette Use and Quitting in Youth	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT02246114` - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women	N/A
Completed	`NCT03448900` - Intervention Study for Smoking Cessation in Spanish College Students	N/A
Completed	`NCT02008292` - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors	N/A
Completed	`NCT01954407` - Young Adults' Responses to Anti-smoking Messages	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.