NCT01121887

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,309

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
Last Updated

May 12, 2010

Status Verified

September 1, 2008

Enrollment Period

2.7 years

First QC Date

May 10, 2010

Last Update Submit

May 11, 2010

Conditions

Smoking Cessation

Keywords

smoking cessationtelephone counsellingmotivational interviewingtreatment integrityTobacco Smoking

Outcome Measures

Primary Outcomes (1)

  • Point prevalence abstinence

    Not one puff of smoke during the previous 7 days

    12 months after initial contact with SNTQ

Secondary Outcomes (1)

  • Continuous abstinence

    12 months after initial contact with SNTQ

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR
Behavioral: Standard treatment

Motivational Interviewing

EXPERIMENTAL
Behavioral: Motivational Interviewing

Interventions

Standard treatmentBEHAVIORAL

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.

Standard treatment
Motivational InterviewingBEHAVIORAL

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.

Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clients with obvious difficulties understanding Swedish
  • Clients with obvious mental impairments
  • Clients using tobacco products other than cigarettes (mainly smokeless tobacco, or "snus")

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asgeir R. Helgason

Stockholm, 10462, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 15369039BACKGROUND

  • 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.

    PMID: 19405969BACKGROUND

  • 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.

    PMID: 18608316RESULT

  • 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.

    PMID: 17852172RESULT

Related Links

MeSH Terms

Conditions

Smoking CessationTobacco Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmokingTobacco Use

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Asgeir R Helgason, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Lars Forsberg, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

January 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 12, 2010

Record last verified: 2008-09

Locations

SE(1)