Intervention Study for Smoking Cessation in Spanish College Students

Study Overview
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Brief Summary
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This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.

Detailed Description
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This study hipotetize that a multicomponent intervention, tailored to college student and conducted by a nurse is more effective than brief advise. The intervention was a multi-component intervention based on the Theory of Triadic Influence and on previous recommendations made in the Surgeon General's report . The strategies of this program consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.

Official Title
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Intervention Study for Smoking Cessation in Spanish College Students: Pragmatic Randomized Controlled Trial

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Behavioral: Multicomponent intervention
* Behavioral: Brief advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months Exclusion Criteria - Students who are ex-smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent intervention<br>The intervention group consisted in face-to-face 50-minute meeting [motivational interviewing (MI)]; online self-help material focused on: (1) decisions; (2) moods; (3) social life; (4) smoking health effects; and (5) quitting; e-mail 15 days before the MI, group therapy 2 months after the MI (60 minutes), a second follow-up visit 4 months after the MI (20 minutes). | Behavioral: Multicomponent intervention<br>* Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)<br>|
| Active Comparator: Brief advice<br>The control group received a brief advice (5-10minutes) and a self-help pamphlet called 'Stop smoking'. Before giving brief advice, the nurse assessed smokers' habits and their willingness to quit. As is usually in this type of studies there were no follow-up sessions for this group. | Behavioral: Brief advice<br>* Brief advice (5-10minutes) and a self-help pamphlet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | The difference in the proportion of students who stopped smoking, between intervention and control subjects. | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of smoked cigaretes | Among students that continued smoking the difference in the mean of cigarrete per day between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program | 6 month follow-up | 
| Quit attempts | Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects | 6 month follow-up | 
| Stages of change according to Prochaska's model | The difference in the distribution on the stages of change between intervention and control subjects at 6 month follow-up | 6 month follow-up | 
| The self-efficacy to avoid smoking, and | the difference in the mean of self-efficacy to avoid smoking between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by self-efficacy to avoid smoking. | 6 month follow-up | 
| Smoking-related beliefs | the difference in the mean of smoking-related beliefs between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by smoking-related beliefs. | 6 month follow-up | 
| Intention to quit smoking | the difference in the mean of intention to quit smoking between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by intention to stop smoking. | 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cessation, College student, Motivational Interview, Self-efficacy, Intention, Beliefs, Young adult