NCT02085616

Brief Summary

The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to offer the client a choice of callback (proactive service) or no callback (reactive service). In the present study clients were not offered a choice, but were randomized to proactive service on even dates and to reactive service on odd dates. Data are collected through postal questionnaires, one baseline and one follow-up after 12 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

2.7 years

First QC Date

March 10, 2014

Last Update Submit

March 10, 2014

Conditions

Smoking CessationTobacco Cessation

Keywords

Smoking cessationTobacco cessationQuitlineTelephone counsellingIntensity

Outcome Measures

Primary Outcomes (1)

  • Point prevalence abstinence

    Not a puff in the last week

    12 months

Secondary Outcomes (1)

  • 6-month continuous abstinence

    12 months

Study Arms (2)

Proactive service

EXPERIMENTAL

Intervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the proactive service the callers to the quitline are offered a number of callbacks.

Behavioral: Proactive service

Reactive service

ACTIVE COMPARATOR

Intervention: Tobacco cessation by telephone support. The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behaviour therapy, and pharmacological consultation. In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like.

Behavioral: Reactive service

Interventions

Proactive serviceBEHAVIORAL

In the proactive service the callers to the quitline are offered a number of callbacks.

Proactive service
Reactive serviceBEHAVIORAL

In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like.

Reactive service

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Tobacco users calling the SNTQ to discuss his/her own tobacco behaviour.
  • The client gives verbal consent to sign up for cessation support.
  • The client return a registration form including a baseline questionnaire

You may not qualify if:

  • Snuff cessation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

Stockholm County Council

Stockholm, 17177, Sweden

Location

Centre for Clinical Research

Västerås, 72189, Sweden

Location

Related Publications (2)

  • Nohlert E, Ohrvik J, Helgason AR. Self-perceived ability to cope with stress and depressive mood without smoking predicts successful smoking cessation 12 months later in a quitline setting: a secondary analysis of a randomized trial. BMC Public Health. 2018 Aug 28;18(1):1066. doi: 10.1186/s12889-018-5973-9.

    PMID: 30153814DERIVED

  • Nohlert E, Ohrvik J, Helgason AR. Effectiveness of proactive and reactive services at the Swedish National Tobacco Quitline in a randomized trial. Tob Induc Dis. 2014 Jun 3;12(1):9. doi: 10.1186/1617-9625-12-9. eCollection 2014.

    PMID: 24936168DERIVED

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Hans Gilljam, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Ásgeir R Helgason, Assoc prof

    Karolisnka Institutet

    PRINCIPAL INVESTIGATOR

  • Eva Nohlert, PhD

    Centre for Clinical Research Västerås, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 13, 2014

Study Start

February 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

SE(3)