Clinical trial NCT02693561: Effects of Deep Breathing,Self-Help Book in Cigarette Consumption,Anxiety,Depression and Motivation to Stop Smoking
Official title: Effectiveness of Deep Breathing, a Self-Help Book and Additive Effects of The Two Interventions in Cigarette Consumption, Anxiety and Depression and Motivation to Stop Smoking in Students of the Anhembi Morumbi University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Self-help book
Deep breathing
Lead sponsor: Anhembi Morumbi University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Smoking is an important public health issue. The self help books may have important motivational implications which associated with deep breath exercises could cease the habit. Goals: Verify the effectiveness of the deep breaths exercises from the self help books along with the two motivational interventions to quit smoking on the anxiety, depression and daily consumption levels. Method: The study will be both prospective and controlled. Individuals will be distributed randomly in 4 different groups: The first group will be doing the deep breath exercises, the second group will read a self help book, the third group will do both reading and exercises and the fourth group will be the control. Anxiety, depression, motivational level and the cigarettes daily consumption will be evaluated previously and after the 15 days intervention. Expected results: Decreasing in anxiety, depression and cigarette consumption plus an increase in the motivation to quit smoking.

Detailed description: Smoking is a major public health problem. According to the WHO (World health organization) it's considered a pandemic issue which kills around 5 million people from related diseases.

This is a growing problem in all South American countries specially where poverty and the lack of instruction make people more vulnerable to the addiction. In addition, the smoking habit has been integrated to these countries cultures because of their economical dependence of it and ostensive marketing.

However, nowadays smoking harm effects are well known including the high risk of developing COPD (chronic obstructive pulmonary disease), heart diseases and many other forms of neoplasms.

The problems concerning smoking were first documented 40 years ago and are still one of the major causes of death which could be prevented. The medical costs associated with its treatment go far beyond the economical benefits from producing and commercializing tobacco.

It's estimated that in 2025, there will be 10 million people dying from tobacco consumption if the world panorama stays as it is. 90% of the teenagers who starts smoking become addicted by they are 19 years old.

According to the Smoking cessation guidelines - 2008 to stop smoking the addiction is recognized as a chronic condition and the interventions to change habits tends to be repeated as it's hard to get a efficient treatment. Even though, the stop smoking is associated in an increase of life quality and that's why it should be stimulated.

Three main mechanisms influence smoking, the first one is positive reinforcement, which is related to the release of acetylcholine, norepinephrine, serotonin, and GABA in the nervous central system caused by the action of nicotine that reduces appetite, improves mood and concentration and generate feelings of pleasure. The second is negative reinforcement, which generates the maintenance of cigarette use to prevent the symptoms of withdrawal symptoms like anxiety, increased appetite, dysphoria, irritability and difficulty in concentrating. The third is the respondent conditioning, which is stimulated by environmental factors, negative emotions and positive that lead to the act of smoke. Thus smoking is a complex behavior that is related to lifestyle, while trying to quit smoking many individuals experience symptoms of withdrawal syndrome which is a major cause of relapse. Deep breathing technique is cited by smokers as a strategy to alleviate these symptoms abstinence.

Mcclernon et al. They found results suggesting that guided deep breathing exercises relieve the symptoms of abstinence nicotine.

According to Tharion et al. deep breathing decreases respiratory rate and increase the variability of heart rate, stimulates the autonomic parasympathetic nervous system and increase the relaxing substances such as endorphins, so it is recommended as a relaxation technique, as well as decreasing tension, anger and depression.

Initially, in addition to clinical assessment of the smoker and assessing the degree of dependence, to assess the degree of motivation is fundamental to start therapy approach.

Prochaska and Diclemente described a stage of readiness model for change (motivation), with the steps of pre-contemplation, contemplation, preparation, action and maintenance (prevent the return behavior, undertaking measures to prevent relapse). First described as a linear model and later as a spiral model, since patients often have relapses, and remain long periods in maintenance stage.

Thus, motivational interventions are critical in smoker's approach in all clinical situations, even when participants need medical support. The self-help books can be effective and have important implications for public health. These psycho-educational interventions are complex and usually contains multiple components that interact and involve behavioral changes of people.

Self-help materials, according to Song et.al., can be effective and less costly than individual therapy or group sessions, which for many people is hard to get. Currently there are materials available in audio, video and computer programs, though the writings are the most commons.

A literature review by Boyce et al. And published by the Cochrane Library, concluded that materials that are tailored individually, eg for pregnant women or young, are more effective than non-adapted materials and both are effective for smoking cessation compared to individuals who did not use the self help material.

In this review, there was no additional benefit of evidence of the use of self-help material associated with other interventions such as advice from a health professional or replacement therapy nicotine and no selected study in the review used the deep breathing technique associated with reading self help material.

However, such evidence is tested in developed countries and more research is needed to investigate its effects in countries where support to smokers are not easily available.

Polonio I.B et al. , Published in 2013 a self-help book with smokers auxiliary order containing the principles of behavioral intervention conducted on Santa Casa de Sao Paulo smoking clinic.

Finally, the hypothesis of the study is that the book will be an effective tool to reduce anxiety, depression and increased motivation to quit smoking, the investigators believe that the addition of deep breathing to read the book will enhance these effects.

Eligibility criteria: Inclusion Criteria:

* students from the Anhembi Morumbi University.
* minimum age of 18 years.

Exclusion Criteria:

* serious chronic diseases
* use of beta blockers.
* pregnant women.

Primary outcomes:
measure: Motivation measured with the Portuguese version of the "URICA" (Scale University of Rhode Island Change Assessment)
timeFrame: 2 weeks
Secondary outcomes:
measure: Nicotine addiction measured whit the Portuguese version of the Fagerstrom test
timeFrame: 2 weeks
measure: Depression measured with the portuguese version of the "BDI" ( The Beck Depression Inventory).
timeFrame: 2 weeks
measure: Anxiety measured with the Portuguese version of the "BAI" ( The Beck Anxiety Inventory)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Anhembi Morumbi University
Study officials:
affiliation: Anhembi Morumbi University
name: Iris Ueda
role: PRINCIPAL_INVESTIGATOR
affiliation: Anhembi Morumbi University
name: Igor Polonio
role: STUDY_DIRECTOR
References:
citation: Muller F, Wehbe L. Smoking and smoking cessation in Latin America: a review of the current situation and available treatments. Int J Chron Obstruct Pulmon Dis. 2008;3(2):285-93. doi: 10.2147/copd.s2654.
citation: McClernon FJ, Westman EC, Rose JE. The effects of controlled deep breathing on smoking withdrawal symptoms in dependent smokers. Addict Behav. 2004 Jun;29(4):765-72. doi: 10.1016/j.addbeh.2004.02.005.
citation: Tharion E, Samuel P, Rajalakshmi R, Gnanasenthil G, Subramanian RK. Influence of deep breathing exercise on spontaneous respiratory rate and heart rate variability: a randomised controlled trial in healthy subjects. Indian J Physiol Pharmacol. 2012 Jan-Mar;56(1):80-7.
citation: Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
citation: Shields RW Jr. Heart rate variability with deep breathing as a clinical test of cardiovagal function. Cleve Clin J Med. 2009 Apr;76 Suppl 2:S37-40. doi: 10.3949/ccjm.76.s2.08.
citation: Song F, Holland R, Barton GR, Bachmann M, Blyth A, Maskrey V, Aveyard P, Sutton S, Leonardi-Bee J, Brandon TH. Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial. Trials. 2012 May 30;13:69. doi: 10.1186/1745-6215-13-69.