Telephone-based Treatment for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Motivational Interviewing in Smoking Cessation: A Controlled Clinical Trial at the Swedish National Tobacco Quitline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121887
• Other study ID #: CAN046684 / LS04010116
• Secondary ID: CAF2006-ASG
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2010
• Last updated: May 11, 2010
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1309
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Asgeir R. Helgason	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Forsberg L, Berman AH, Kallmén 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. — View Citation

Forsberg L, Källmén 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): — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence abstinence	Not one puff of smoke during the previous 7 days	12 months after initial contact with SNTQ	No
Secondary	Continuous abstinence	Not a single puff of smoke within the past six months or more	12 months after initial contact with SNTQ	No

External Links

•   Karolinska Institutet