- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121887
Telephone-based Treatment for Smoking Cessation
Motivational Interviewing in Smoking Cessation: A Controlled Clinical Trial at the Swedish National Tobacco Quitline
Aim: to assess the effect of adding Motivational Interviewing (MI) to the existing smoking cessation treatment protocol at the Swedish National Tobacco Quitline (SNTQ).
Methods: Experienced counsellors at SNTQ either received further training in the standard treatment (ST) protocol (including Cognitive Behavioural Therapy (CBT)) or a comprehensive regime of training in MI. 1309 clients were randomized to either the ST group or the group with MI added to the treatment protocol. In order to ensure treatment integrity among counsellors, MI skill was assessed using the Motivational Interviewing Treatment Integrity Code (MITI).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 10462
- Asgeir R. Helgason
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clients have to express a desire for support regarding smoking cessation
- Clients have to be willing to confirm their identity by answering a baseline registration questionnaire
Exclusion Criteria:
- Clients with obvious difficulties understanding Swedish
- Clients with obvious mental impairments
- Clients using tobacco products other than cigarettes (mainly smokeless tobacco, or "snus")
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interviewing
|
Telephone-based smoking cessation counselling with Motivational Interviewing added to the standard treatment protocol. Clients are offered a choice between "reactive treatment" (clients initiate all contact) and "proactive treatment" (counsellors call back at appointed dates). Printed information material tailored to clients' needs is offered free of charge. |
Active Comparator: Standard treatment
|
Telephone-based smoking cessation counselling based on a combination of coaching and cognitive behavioural therapy (CBT) techniques. Counsellors are also trained in giving tailored advice regarding the use of smoking cessation aids. Clients are offered a choice between "reactive treatment" (clients initiate all contact) and "proactive treatment" (counsellors call back at appointed dates). Printed information material tailored to clients' needs is offered free of charge. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point prevalence abstinence
Time Frame: 12 months after initial contact with SNTQ
|
Not one puff of smoke during the previous 7 days
|
12 months after initial contact with SNTQ
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous abstinence
Time Frame: 12 months after initial contact with SNTQ
|
Not a single puff of smoke within the past six months or more
|
12 months after initial contact with SNTQ
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lars Forsberg, PhD, Karolinska Institutet
- Principal Investigator: Asgeir R Helgason, PhD, Karolinska Institutet
Publications and helpful links
General Publications
- Helgason AR, Tomson T, Lund KE, Galanti R, Ahnve S, Gilljam H. Factors related to abstinence in a telephone helpline for smoking cessation. Eur J Public Health. 2004 Sep;14(3):306-10. doi: 10.1093/eurpub/14.3.306.
- Nohlert E, Tegelberg A, Tillgren P, Johansson P, Rosenblad A, Helgason AR. Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden: a randomized trial. BMC Public Health. 2009 Apr 30;9:121. doi: 10.1186/1471-2458-9-121.
- Forsberg L, Berman AH, Kallmen H, Hermansson U, Helgason AR. A test of the validity of the motivational interviewing treatment integrity code. Cogn Behav Ther. 2008;37(3):183-91. doi: 10.1080/16506070802091171.
- Forsberg L, Kallmen H, Hermansson U, Berman AH, Helgason AR. Coding counsellor behaviour in motivational interviewing sessions: inter-rater reliability for the Swedish Motivational Interviewing Treatment Integrity Code (MITI). Cogn Behav Ther. 2007;36(3):162-9. doi: 10.1080/16506070701339887.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAN046684 / LS04010116
- CAF2006-ASG (Other Grant/Funding Number: Cancerfonden)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Standard treatment
-
Paul CrawfordCompleted
-
Hospital Clinic of BarcelonaUnknown
-
Hospices Civils de LyonTerminatedAnal IncontinenceFrance
-
Yale UniversityNational Institutes of Health (NIH)Completed
-
BaroPace Inc.JSS Medical Research Inc.RecruitingHypertension | Heart Failure With Preserved Ejection Fraction (HFpEF)India
-
The University of Hong KongNot yet recruitingStroke | Small Vessel Cerebrovascular Disease
-
Pharmazz, Inc.CompletedHypovolemic ShockIndia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingEsophageal Cancer | Palliative Care | RadiotherapyItaly
-
Uppsala UniversityThe Swedish Research Council; Uppsala County Council, SwedenCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingThoracic Cancer | Palliative Care | RadiotherapyItaly