Smoking CessationPhase 3NCT01121887
Telephone-based Treatment for Smoking Cessation
A Phase 3 study testing Standard treatment and Motivational Interviewing in people with Smoking Cessation, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Standard treatment and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,309 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2005to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clients with obvious difficulties understanding Swedish
- Clients with obvious mental impairments
- Clients using tobacco products other than cigarettes (mainly smokeless tobacco, or "snus")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Smoking Cessation
- Being tested
- Standard treatment, Motivational Interviewing
- Keywords
- smoking cessation, telephone counselling, motivational interviewing, treatment integrity, Tobacco Smoking
- Medical subject headings
- Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentBehavioural
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 InterviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Not described Receives: Behavioral: Standard treatment |
| Motivational Interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence
Not one puff of smoke during the previous 7 days
Measured: 12 months after initial contact with SNTQ
Secondary outcomes (1)
Continuous abstinence
Not a single puff of smoke within the past six months or more
Measured: 12 months after initial contact with SNTQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJan 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Investigators
- Asgeir R Helgason, PhD, Principal investigator, Karolinska InstitutetLars Forsberg, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121887
- Sponsor's protocol ID
- CAN046684 / LS04010116
- Other IDs
- CAF2006-ASG
- Status last verified
- Sep 2008
- First submitted
- 10 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15369039Nohlert 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.
PubMed 19405969Forsberg 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.
PubMed 18608316Forsberg 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.
PubMed 17852172
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing in Smoking Cessation: A Controlled Clinical Trial at the Swedish National Tobacco Quitline
- ClinicalTrials.gov ID
- NCT01121887
- Acronym / sponsor ID
- CAN046684 / LS04010116
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, telephone counselling, motivational interviewing, treatment integrity, Tobacco Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,309 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Behavioral: Standard treatment |
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Clients with obvious difficulties understanding Swedish
- Clients with obvious mental impairments
- Clients using tobacco products other than cigarettes (mainly smokeless tobacco, or "snus")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatmentTelephone-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. | Behavioural | Standard treatment |
| Motivational InterviewingTelephone-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. | Behavioural | Motivational Interviewing |
Primary outcome
Point prevalence abstinence
Time frame: 12 months after initial contact with SNTQ
Not one puff of smoke during the previous 7 days
1 secondary outcome
Continuous abstinence
Time frame: 12 months after initial contact with SNTQ
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Background: PubMed 15369039Helgason 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.
- Background: PubMed 19405969Nohlert 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.
- Results publication: PubMed 18608316Forsberg 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.
- Results publication: PubMed 17852172Forsberg 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.
- Karolinska InstitutetLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir R Helgason, PhD principal investigator
Karolinska Institutet
Lars Forsberg, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard treatment and Motivational Interviewing in people with Smoking Cessation, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence (time frame: 12 months after initial contact with SNTQ). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121887, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010; AzTrials last refreshed its copy on 4 Nov 2026.