|Year : 2020 | Volume
| Issue : 1 | Page : 25-30
Effectiveness of cognitive-behavioral therapy compared with basic health education for tobacco cessation among smokers: A randomized controlled trial
Mohammed Umar Farooq, Manjunath P Puranik, SR Uma
Department of Public Health Dentistry, Government Dental College and Research Institute, Bengaluru, Karnataka, India
|Date of Submission||14-Oct-2019|
|Date of Decision||27-Jan-2020|
|Date of Acceptance||03-Feb-2020|
|Date of Web Publication||2-Mar-2020|
Dr. Mohammed Umar Farooq
Department of Public Health Dentistry, Government Dental College and Research Institute, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Tobacco is a risk factor for oral cancer, adult periodontal diseases, and cleft lip and palate in children. Tobacco cessation counseling has been shown to improve the likelihood of achieving success for quitting the habits. Aim: This study aimed to assess the effectiveness of cognitive-behavioral therapy (CBT) compared with basic health education (BHE) for tobacco cessation among smokers in Bengaluru city. Materials and Methods: A randomized controlled trial was conducted over a period of 6 months among smokers attending a tobacco cessation center in a dental college in Bengaluru city. The participants were assigned to either CBT or BHE groups with 1:1 allocation sequence ratio. Randomization and allocation concealment were done by an investigator who had no clinical involvement in the trial. Nicotine dependence was assessed using the Fagerstrom's Addiction Scale for smokers, while motivational levels were assessed using Transtheoretical model. The groups were followed up for 4 and 12 weeks. Statistical analysis was done using the Statistical Package for Social Sciences (SPSS 22.0, IBM, Armonk, NY, USA). Paired and unpaired “t“-tests, Chi-square test, Fisher's exact test, and analysis of variance test were applied. Statistical significance was considered atP < 0.05. Results: Majority of the study participants started smoking at an early age and had long duration and cigarette smoking years. Among CBT group, the mean Fagerstrom's addiction score at baseline (4.8 ± 7.3) significantly reduced (3.8 ± 3.1) at the 1st follow-up and at the 2nd follow-up (3.5 ± 8.9) (P < 0.001). The proportion of smokers with frequency more than ten cigarettes per day reduced from baseline (P = 0.16) to the 2nd follow-up (P = 0.07) in CBT group compared to BHE group. Conclusion: CBT is effective in reducing tobacco habits and addiction levels when compared to BHE among smokers. Tobacco cessation counseling using CBT has been found to reduce smoking habits, thereby improving the possibility of quitting the habits.
Keywords: Cognitive-behavioral therapy, health education, smokers, tobacco
|How to cite this article:|
Farooq MU, Puranik MP, Uma S R. Effectiveness of cognitive-behavioral therapy compared with basic health education for tobacco cessation among smokers: A randomized controlled trial. J Indian Assoc Public Health Dent 2020;18:25-30
|How to cite this URL:|
Farooq MU, Puranik MP, Uma S R. Effectiveness of cognitive-behavioral therapy compared with basic health education for tobacco cessation among smokers: A randomized controlled trial. J Indian Assoc Public Health Dent [serial online] 2020 [cited 2020 Apr 4];18:25-30. Available from: http://www.jiaphd.org/text.asp?2020/18/1/25/279812
| Introduction|| |
Globally, tobacco is responsible for death of one in ten adults (about 5 million deaths each year), with 2.41 (1.80–3.15) million deaths occurring in developing countries and 2.43 (2.13–2.78) million occurring in developed countries. If the existing smoking trends continue, the annual mortality will surpass 10 million by the year 2030 (WHO). In India, about 5% of all deaths in women and 20% of all deaths in men aged 30–69 years, which totaled to 1 million deaths per year, were caused by cigarette and beedi smoking.
Tobacco use post diagnosis diminishes the efficacy of medical treatment and increases the rate and severity of treatment-related complications such as pulmonary and circulatory problems, infections, impaired wound healing, mucositis, and xerostomia. Tobacco is a risk factor for oral cancer, adult periodontal diseases, and congenital defects such as cleft lip and palate in children whose mothers smoke during their pregnancies. It also increases the risk for recurrence and a second primary tumor and reduces survival time. Hence, there is a need for interventions for the prevention and control of tobacco use. The smoking control interventions array from behavioral support (counseling and advice) to medicinal therapies. Behavioral intervention combined with pharmacotherapy is the standard of care for treating tobacco dependence.
Cognitive-behavioral therapy (CBT) is, in fact, an umbrella term for many different therapies that share some common elements. Two of the earliest forms of CBT were rational emotive behavior therapy and cognitive therapy. Cognitive therapy helps people to develop alternative ways of thinking and behaving, which aims to reduce their psychological distress. Whereas, CBT aims to help people become aware of when they make negative interpretations, and of behavioral patterns which reinforce the distorted thinking.
CBT includes cessation of the habit, risk perceptions (e.g., for recurrence), quitting self-efficacy, fatalistic beliefs, pros and cons of quitting, and emotional distress. This provides encouragement and support, education, and coping skills training for quitting the deleterious habits of the individuals. Well-established CBT techniques help in the psychological correlates of substance use, self-monitoring, and cognitive restructuring. On the other hand, basic health education (BHE) improves the knowledge of individuals of the danger of cigarette smoking and encourages quitting of tobacco use.
However, few studies have been done in India elucidating the significance of CBT in tobacco cessation habit.
In a study conducted in Lucknow it was concluded though CBT performed better than BHE, mean score reduction was found to be more in CBT than in BHE. Hence, this study was conducted to assess the effectiveness of CBT compared with BHE for tobacco cessation among smokers in Bengaluru city. The research hypothesis was CBT is effective in reducing tobacco habits and addiction levels when compared to BHE among smokers.
| Methodology|| |
A randomized controlled trial was conducted among smokers visiting a dental college in Bengaluru from August 2018 to January 2019. A protocol of the intended study was submitted to the institutional ethical committee and review board, and the ethical clearance was obtained (ethical approval number GDCRI/IEC-ACM (20)/9/2018-19). Necessary permission was obtained from the head of the institute, before conducting the study. Written informed consent was obtained from the participants after explaining the purpose clearly. This study was carried out in accordance with the ethical standards of the World Medical Association for Human Experimentation 2008 version of Helsinki declaration. This study was in agreement with the Consolidated Standards of Reporting Trials guidelines for reporting clinical trials.
The investigator was trained in the department of public health dentistry, for providing CBT and BHE. The training included theoretical aspects of well-established CBT techniques used to address the psychological correlates of tobacco use, including counseling, prompts, web and media supplements, smoking cessation materials, and modeling. The content of the sessions was tailored to address the particular barriers to cessation that were exhibited by the patient visiting tobacco cessation center. Cognition variables thought to be predictors of smoking behavior were assessed. BHE provided information on the negative effects of smoking and were advised to refrain from tobacco usage. The trained investigator was calibrated with the execution of intervention using study screens (laptops), pamphlets, and information material on cessation of habits for few of the patients visiting tobacco cessation center before commencing the research.
The sample size was calculated using G Power software (version 220.127.116.11, Heinrich-Heine-Universität, Düsseldorf, Germany) with a statistical power of 90% at 95% confidence interval and effect size (d) of 0.89. The sample size was 24 that was rounded off to 30 for each group CBT or BHE considering dropouts. Thus, a total of sixty individuals were included in the study. The study participants were recruited from the tobacco cessation center at a dental college in Bengaluru. Current smokers attending tobacco cessation center were included. Participants with mental and cognitive problems, those who received tobacco cessation counseling previously, and those under nicotine replacement therapy (NRT) were excluded from the study.
The participants were assigned to either CBT or BHE group using simple randomization technique with random allocation sequence of a 1:1 allocation ratio generated by Randomizer online software (RANDOM.ORG. Randomness and Integrity Services Ltd. Dublin – Ireland). The allocation sequence was concealed from the primary researcher using sequentially numbered, opaque, sealed, and stapled envelopes. Randomization and allocation concealment were done by an investigator who had no clinical involvement in the trial. Once allocated to a particular arm, neither the primary researcher nor the participants were blind to the participant's arm assignment.
Data collection and intervention were performed at baseline and at follow-up (4 and 12 weeks). Data were collected using a structured proforma which included demographic profile, details of smoking (age of onset, average number of cigarettes used per day, number of years of regular tobacco use, cigarette years, and average number of cigarettes smoked per day [CPD] in the last 1-month) followed by the assessment of Fagerstrom's Addiction Scale for Smokers and motivational levels using the Transtheoretical model.
Interventions for the study groups included CBT and BHE.
Cognitive behavioral therapy
Participants in this group were taught cognitive behavioral cessation and relapse prevention strategies. These included discussions on barriers to cessation, quitting, self-efficacy, previous quit attempts, risk perceptions, and pros and cons of quitting. The sessions were designed to target the psychological factors linked to tobacco cessation including risk perceptions (e.g., for recurrence), fatalistic beliefs, and emotional distress. This therapy provided encouragement and support and training on educational and coping skills, and it was repeated at every follow-up.,
Basic health education
This intervention served as a control arm and provided information on the harmful effects of tobacco use. The participants were advised to think positively, keep themselves busy, and remove tobacco products from his/her surroundings. All these motivational messages were repeated at every follow-up.
The data collected were entered into MS Excel spreadsheet. Data were analyzed using the Statistical Package for Social Sciences (SPSS 22.0, IBM, Armonk, NY, USA). Descriptive and inferential analyses were done. The Shapiro–Wilk test was used to test the normality of the data. The data followed normal distribution, hence appropriate parametric tests were used to compare the groups. Paired and unpaired “t̶XS0;-tests, Chi-square test, Fisher's exact test, and analysis of variance tests were used for intragroup and intergroup comparisons. Statistical significance was considered at P < 0.05.
| Results|| |
The current study group consisted of participants aged 18–74 years. The mean age of the study participants in the CBT group was 38.4 ± 3.2 years, whereas in the BHE group, it was 41.8 ± 2.48 years. Almost all participants were males and belonged to low socioeconomic status with lesser education and income levels [Table 1]. Smoking characteristics revealed early age of onset (16 years of age) and long duration (>10 years) and cigarette-years (>10 cigarette-years). The proportion of smokers with frequency more than ten cigarettes per day reduced from baseline (P = 0.16) to the 2nd follow-up (P = 0.07) in CBT group compared to BHE group [Table 2]. Similarly, the average number of cigarettes smoked in the last 1 month reduced in both groups although the difference was not statistically significant. The Mean Fagerstrom's score reduction was found to be significantly higher in the CBT group (3.5 ± 8.9) than that in the BHE group (4.0 ± 9.8), and the difference was found to be statistically significant from baseline to the 2nd follow-up (P < 0.001) [Table 3]. At the end of the 2nd follow–up, majority of the participants in both the groups had moved to contemplation stage, whereas some participants in the CBT group had reached preparation stage compared to BHE group [Table 4].
|Table 2: Number and percentage of the study groups by the average number of cigarettes smoked per day at baseline and follow-ups|
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|Table 3: Distribution of the study groups according to mean Fagerstrom's addiction scale for smokers at baseline and follow ups|
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|Table 4: Number and percentage of the study groups by motivational stage assessments at baseline and follow-ups|
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| Discussion|| |
Tobacco use is a risk factor for many diseases, especially those affecting the heart, liver, and lungs, as well as many cancers. In 2008, the WHO named tobacco use as the world's single-greatest preventable cause of death. Tobacco contains the stimulant alkaloid nicotine. Dried tobacco leaves are mainly used for smoking in cigarettes, cigars, pipes, shishas as well as E-Cigarettes (both rechargeable and disposable), E-Cigars, E-Pipes, and Vaporizers.
Tobacco cessation counseling has been shown to improve the likelihood of achieving success. Counseling programs provide information and resources to help tobacco users develop a quit plan, address specific barriers to quitting, seek support for their efforts, and manage withdrawal symptoms and stress to prevent relapse. The most effective counseling is tailored to meet individual needs and preferences. The methods and intensity vary based on the type and amount of support needed. CBT helps to deal with overwhelming problems in a more positive way by breaking them down into smaller parts and focuses on current problems, rather than focusing on issues from the past.
Twelve randomized controlled trial studies were carried out to assess the effectiveness of various educational techniques in tobacco cessation.,,,,,,,,,,, Studies have assessed the effectiveness of CBT with BHE, general health education CBT self-help program virtual cue exposure therapy (CET) nortriptyline hydrochloride sustained-release bupropion NRT and bupropion transdermal NRT, motivational interviewing and self-control training and counseling, NRT, and a combination of the both. Duration of the trials ranged 2–64 weeks.,,,,,,,,,,, The results of the current study are compared with those of earlier studies wherever possible.
In this study, participants were in the age group of 18–74 years. Previous studies have included age groups between 14 and 65 years.,,,,,, The mean age in literature ranged from 19–48.32 years, for CBT group. The mean age in the present study was comparable with that of the existing literature and similar to one study (42.7 ± 7.9 years). Men are more likely to smoke cigarettes to control their emotions than women. Smoking had been reported to reduce anger and sadness in men. Majority were males,,,,,, and one study had recruited males only in earlier studies. In this study, almost all the participants in CBT and BHE groups were male. Socioeconomic factors, together with poorer participant's levels of education and income, increase the likelihood of smoking habit.
The socioeconomic condition of the population does play a major role in the prevalence of tobacco habits. The fact that the tobacco habits are the causation of lack of social and emotional security can be linked to the low socioeconomic group parents, the working-class parents, and the large family groups. The degree of modernization and the ability to cope with such a society without mental tension is the major factor in determining the presence or absence of habit, as the habits act as mental stress releasers. Education and awareness of the individuals matters a lot in controlling tobacco habits in the community. In this study, most of the study participants in both of the groups had education for 7 years or more. This is in accordance with studies.,,,,,,, The current study had skilled workers and their family income per month was from '11,606 to '17,408. Majority belonged to lower middle class.
Tobacco product use begins and gets established primarily during adolescence. Nearly nine out of ten cigarette smokers first try cigarette smoking by the age of 18 years. In this study, two-fifth of the study participants in both the groups started smoking at 16–20 years, whereas other studies showed lower age of onset (14.7–15.7 years)., For most smokers, duration plays a critical role in quitting as it is a difficult process. Many smokers try to quit repeatedly before they succeed, with some relapsing even after a lengthy period of abstinence. In earlier studies,,,, the duration ranged from 2.5% to 72%. In the current study, majority of the study participants smoked for more than 10 years. The average duration of smoking was higher among CBT group (8.3 ± 3.3 years) than BHE group (7.5 ± 2.9 years). Cigarette-years refer to smoking index (CPD × years of tobacco use). Majority of the study participants belonged to 5-year or more cigarette-years. Among CBT group, the average cigarette-years were 13.6 ± 11.08, whereas for BHE group, they were 14.11 ± 12.01.
Three-fourth of the study participants smoked <10 cigarettes per day in the current study, which is in contrast with a previous study where less number of participants (10%) smoked <10 cigarettes per day. This is because their study group included smokeless tobacco also. In other studies, the mean number of cigarettes per day ranged from 13 to 38.,,,,,,,xs In the present study, majority of the study participants smoked up to 250 cigarettes in the previous 1 month. On follow-up, the average number of CPD reduced from baseline to the 2nd follow-up in both the groups, however the difference was statistically significant in CBT group.
In the current study, the Fagerström Test for Nicotine Dependence score at baseline was 4.8 ± 7.3 in CBT group, which is comparable to studies reported in literature (4 ± 2.0,,,, 4.87 ± 1.06, and 5.4 ± 2.2–5.6 ± 2.1).
Highly significant difference in the mean Fagerstrom's addiction score was found between baseline and the 1st follow-up and also at the 2nd follow-up (P < 0.001) only in CBT group. Whereas, in a previous study, significant reductions were reported in CBT group and BHE group. It was interesting to note that the mean Fagerstrom's score reduction was more in CBT group than in BHE group, despite the interventions having equivalent levels of contact. This suggested that the differences in the interventions were caused by strategies which were adopted. The only vital thing that mattered was the patient motivation. Both the groups demonstrated migration from precontemplation stage to contemplation stage. However, about 13% of the participants had moved to preparation stage in CBT group compared to 3% in BHE group, which could be attributed to the high impact of CBT compared to BHE. However, this finding is lower when compared to a study in literature (45.5%). CBT was found to be effective than BHE in previous literature,,,,,, and only one study showed virtual CET to be more effective than CBT for nicotine dependence.
Various efficacious methods are available for interfering with the reinforcement of smoking cessation. Effective treatments pooled with behavioral support (CBT) and the 5 As framework of smoking cessation should be presented to every smoker who is interested in stopping smoking. Although the use of pharmacologic methods available for smoking cessation substantively improves the probability of achieving fruitful abstinence, the best consequences for cessation are realized when pharmacologic agents are combined with behavioral methodologies to treatment, such as tobacco dependence counseling.
This study had some limitations. Tobacco habits were assessed using questionnaires, hence biases pertaining to questionnaire studies could be present. Shorter study duration and follow-ups, unequal gender distribution, and only smoking form of tobacco use were considered. The findings from the present study point out the requisite for establishing an appropriate educational, preventive, and treatment measure coupled with efficient surveillance for smoking cessation. Future investigations are warranted to test the effectiveness of CBT with the combination of BHE in community settings and should include long-term follow-up assessments with gender distribution and objective assessment of tobacco habits.
| Conclusion|| |
CBT is effective in reducing tobacco habits and addiction levels when compared to BHE among smokers. Hence, CBT can be incorporated in tobacco cessation interventions in clinical practice.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]