Effectiveness of intensive group and individual interventions against smoking in primary health care settings

ISRCTN	ISRCTN32323770
DOI	https://doi.org/10.1186/ISRCTN32323770
Protocol serial number	PI03/1648
Sponsor	Ministry of Health and Consumer Affairs (Spain)
Funder	Ministry of Health and Consumer Affairs (Spain) - Health Research Fund

Submission date: 11/05/2009
Registration date: 17/06/2009
Last edited: 02/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maria Ramos Monserrat
Scientific

Conselleria de Salut i Consum
C/ Cecili Metel 18
Palma
07003
Spain

Phone	+34 971176891
Email	mramos@dgsanita.caib.es

Study information

Primary study design	Interventional
Study design	Three-arm individually randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of intensive group and individual interventions against smoking in primary health care settings: a three-arm individually randomised controlled trial
Study objectives	In primary health care settings, an intensive group intervention against smoking is more effective than an intensive individual intervention.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Continued abstinence at 12 months confirmed through CO-oximetry
Key secondary outcome measure(s)	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
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	597
Key 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.
Key exclusion criteria	1. Individuals less than 18 years of age 2. Terminal ilness 3. Certain mental health conditions (dementia and schizophrenia)
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

Spain

Study participating centre

Conselleria de Salut i Consum

Palma
07003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/02/2010		Yes	No
Protocol article		01/11/2005		Yes	No