Condition category
Mental and Behavioural Disorders
Date applied
11/05/2009
Date assigned
17/06/2009
Last edited
02/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Ramos Monserrat

ORCID ID

Contact details

Conselleria de Salut i Consum
C/ Cecili Metel 18
Palma
07003
Spain
+34 971176891
mramos@dgsanita.caib.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI03/1648

Study information

Scientific title

Effectiveness of intensive group and individual interventions against smoking in primary health care settings: a three-arm individually randomised controlled trial

Acronym

Study hypothesis

In primary health care settings, an intensive group intervention against smoking is more effective than an intensive individual intervention.

Ethics approval

1. Balearic Islands Ethical Board approved on the 26th February 2003 (ref: PI031648)
2. Mallorca Primary Health Care Research Board approved on the 27th February 2003 (ref: PI031648)

Study design

Three-arm individually randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Smoking

Intervention

The participants were randomly allocated to the following three arms:
Arm 1: Intensive group intervention
Arm 2: Intensive individual intervention
Arm 3: Usual minimal intervention

Intensive interventions (both group and individual):
Consisted of counselling, psychological support and standardised follow-up. Pharmacological treatment with nicotine derivatives or bupropion was also offered as an option at the physician's judgment.

Usual minimal intervention:
Brief counselling. Pharmacological treatment was also offered as an option at the physician's judgement.

The total duration of interventions was variable. In individual intensive intervention, the protocol recommended 20 minutes for the first visit and 10 minutes for the following. In group intensive intervention, the protocol recommended around 1 hour for all visits. In practice, more time was devoted, especially in group intervention. In usual minimal intervention, no recommendations were given.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Continued abstinence at 12 months confirmed through CO-oximetry

Secondary outcome measures

1. Self-reported continued abstinence at 12 months
2. Point abstinence at 12 months confirmed through CO-oximetry
3. Point self-reported abstinence at 12 months

Overall trial start date

01/01/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

People (both male and female) who smoked and who were in the preparatory phase in accordance with Prochaska's and Di Clemente's transtheoretical model of health behaviour.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

597

Participant exclusion criteria

1. Individuals less than 18 years of age
2. Terminal ilness
3. Certain mental health conditions (dementia and schizophrenia)

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Conselleria de Salut i Consum
Palma
07003
Spain

Sponsor information

Organisation

Ministry of Health and Consumer Affairs (Spain)

Sponsor details

Instituto de Salud Carlos III
C/ Sinesio Delgado 6
Madrid.
28029
Spain

Sponsor type

Government

Website

http://www.isciii.es

Funders

Funder type

Government

Funder name

Ministry of Health and Consumer Affairs (Spain) - Health Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol (Spanish only):
Ramos M, Milán J, Medina D, Puig B, Janer JM y Ripoll J. Efectividad de las intervenciones grupal e individual avanzadas para el abordaje del tabaquismo en atención primaria. Aten Primaria. 2005; 36 (8): 462-5
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20178617

Publication citations

  1. Results

    Ramos M, Ripoll J, Estrades T, Socias I, Fe A, Duro R, González MJ, Servera M, Effectiveness of intensive group and individual interventions for smoking cessation in primary health care settings: a randomized trial., BMC Public Health, 2010, 10, 89, doi: 10.1186/1471-2458-10-89.

Additional files

Editorial Notes