Materials and Methods
Design
The study was designed as a randomized controlled trial between March 2010 and December 2011. It was performed at the Ondokuz Mayıs University Medical Faculty Department of Family Practice Smoking Quittance Clinic, Turkey. Before the study began, a power analysis was conducted to calculate the number of participants within different treatment groups. Based on the literature, we assumed standard deviation of 22, 8 levels, a target power of 0.8, and a maximum difference of 20. Based on that analysis, we calculated a minimum number of 28 participants in each treatment group. To minimize the risk of affecting the study outcomes, we decided to investigate the effects of this program on smokers who had never tried to quit before. Relapsed smokers might have experienced some of the cessation strategies and had a negative attitude toward the methods they had used previously. The other criteria for inclusion in the study were willingness to take part in and attend all sessions, age >18 years, intent to quit smoking within 6 months, smoking >10 cigarettes a day, not taking any psycho-regulatory medication (antidepressants, anxiolytics, or antipsychotics), not having any psychiatric illnesses, not being pregnant or breastfeeding, and applying all the program session content for 6 months.
In our clinic, smokers are placed on a waiting list for the following month after their initial sociodemographic, health, and smoking features are investigated. After we announced that a cognitive behavioral therapy—oriented anger management and stress control program aiming to increase these skills of smokers was to be implemented, we selected smokers who fulfilled the research criteria for the study and control groups from these waiting lists. Each month, a new study group (a total of 12 different study groups) and control group (a total of 12 different control groups) were added to the research; participants were selected from the previous month's waiting list.
To obtain optimal efficiency from cognitive behavioral treatment (enough experiences to be shared, stimuli for discussion, etc.), the number of participants in the groups had to be limited to approximately 20. This would have limited our research to a single study and control group. Therefore we decided to form each month new study (12 in total) and control (12 in total) groups limited to approximately 20 participants selected at random from our clinic's waiting list. The first study and control subgroups were selected from the waiting list of February 2010, and the 12th and last subgroups from the January 2011 list. The total study population consisted of 2348 smokers admitted to our clinic between February 2010 and January 2011. Of these, 350 smokers (175 smokers in each group) were selected for the research. To perform basic randomization in groups, participants who fulfilled the study criteria and were on the previous month's waiting list were divided into 2 different lists by sex in order of application. First, the male and female smokers at the top of both lists were assigned to the study subgroup, the second smokers on both lists to the control subgroup, the third to the study subgroup, the fourth to the control subgroup, and so on, until they were equally divided. The remaining smokers on the waiting list who did not meet the study criteria (n = 1418) or who were not interested in participating in the research (n = 580) were administered our clinic's standard treatment procedure (control group treatment program), consisting of approximately 3 months of treatment and follow-up. An informed consent form was obtained from each participant, and a confidentiality contract was signed by study group members.
At the beginning of the program, each participant in the study and control subgroups was asked to respond to the Fagerstrom Test for Nicotine Dependence (FNDT), the State Trait Anger Inventory, and the Styles of Coping with Stress Inventory (pretests). Pretests were collected from subgroups between March 2010 (first study and control subgroups) and January 2011 (12th study and control subgroups). Our clinic's standard quitting procedure was applied to both subgroups, whereas the 5-week anger management and stress control coping program was applied to the study subgroups alone. Smoking status of participants in both subgroups, together with their skills, were compared and recorded as soon as the program ended, 30 to 35 days from their first visits (post-test results). Post-test results were collected from subgroups between May 2010 (first study and control subgroups) and March 2011 (12th study and control subgroups). The same data were collected the third and sixth months after post-tests were administered to both subgroups (first and second follow-up tests). First follow-up tests were collected between September 2010 (first study and control subgroups) and August 2011 (12th study and control subgroups) and the second follow-up tests between November 2010 and December 2011 (including relapsed participants). At the end of the study, the results from the participants in these subgroups were pooled and evaluated as a single study group and single control group. Although the participants in the study subgroups knew that they were in the anger management and stress control program, the data collectors were blind when applying the tests. Relapsed participants reenlisted in our clinic for a new round of treatment 6 months later.
The participants were expected not to smoke for any reason after the contracted quit day. Smoking status of patients was established by self-report and assessment of carbon monoxide with an inhaler. Participants who relapsed on just 1 or 2 occasions were not excluded from the study. Participants with readings of ≤10 ppm carbon monoxide were regarded as smoking free. Participants' smoking status was investigated 4 times. The first investigation was performed between the 7th and 10th days after the contracted quit day (post-test). The second investigation was the 30th day after the quit day, the 3rd was at the 90th day (1st follow-up test), and the 4th was at approximately the 180th day (2nd follow-up test). A flowchart of the study procedure administered to all study and control subgroups is shown in Figure 1. The study was performed in all subgroups in this chronological order, with no more than 3 or 4 days' delay because of differences in quitting times and some national holidays.
(Enlarge Image)
Figure 1.
Flowchart of the study procedure administered to all participants in the study and control groups (a total of 12 groups); a new study and control group were included every month between March 2010 and February 2011.
Both groups received a 40-minute session of the same workshop on their first visit. Participants in the control group received nearly 150 minutes of individualized face-to-face treatment (in approximately 10 visits) for 6 months (control groups' treatment program). Participants in the study group received 630 minutes of group (5 + 2 sessions) and 100 minutes of individualized (10 visits) face-to-face treatment for 6 months (anger management and stress control program). We calculated that approximately 440 work hours (for 175 participants) were needed for the control group and nearly 420 work hours were needed for the study group in 6 months.
Control Group Treatment Program (Clinic's Standard Program)
All subjects took part in several types of smoking cessation activities according to their smoking status, dependency level, and indications. This program includes a group workshop, face-to-face interventions aimed at maintaining lifestyle changes, NRT, and pharmacotherapy. Patients who apply to the Ondokuz Mayıs University Family Practice Smoking Cessation Clinic are enrolled in an average 3-month smoking cessation program. Approximately 10 interviews (4 in the first month, 3 in the second, and 3 in the third) are conducted during the program. If necessary, one visit per month can be planned. Appointments are made to form groups of 20 patients each.
During the first meeting, a workshop is held at which smoking cessation techniques and nicotine addiction are discussed with the group for approximately 1 hour. At this workshop, members share previous smoking cessation experiences. All group members are encouraged to share their experiences and thoughts concerning how they started smoking, the benefits of quitting, any close friends or relatives who were harmed by smoking, any close friends or relatives who successfully quit smoking, and previous attempts to quit (How long did you quit for? What went wrong? Which method was used?). In the next step, a short, interactive presentation is given to consolidate negative emotions against smoking and reinforce the desire to quit. In this part of the session, strategies for smoking cessation, drug therapies including NRT and behavioral approaches to dealing with addiction, are discussed. To avoid withdrawal symptoms (mostly coping with anger and stress), basic techniques (increase physical activity, change one's environment, the effect of relaxing music, hobbies, and deep breathing, etc.) are discussed for at least 20 minutes. Patients first are asked to perform some lifestyle modifications and change their smoking habits (discussion and handouts). These changes aim to prepare the patient for the quitting day. They include changing the cigarette brand used, not smoking for 90 minutes after waking up, smoking only after meals or with tea or coffee (if these usually accompany smoking), avoiding offering and accepting cigarettes from other people, smoking alone (if being in a group triggers smoking), changing one's usual smoking places (at home, work, etc.), refraining from alcohol intake for 3 months (if smoking accompanies alcohol use), and, finally, increasing the amount of daily physical exercise (half hour, moderate). They are finally asked to find a quit buddy from their workshop group for the future quitting process; then the workshop is concluded.
On the same day, each patient is privately interviewed for a minimum of 20 minutes, and a general physical examination (anthropometric parameters included) is performed. The principles of motivational interviewing are used during this session. Each smoker is given an individualized behavioral counseling session lasting 20 minutes. In this first step, the smoker is encouraged to make lifestyle changes, and the next appointment is scheduled, usually for a week to 10 days later. At the second appointment, lifestyle changes are evaluated, the basic techniques for withdrawal symptoms are revised face to face, and a quit day is agreed on (generally 10 to 12 days later). Pharmacological treatment (drugs) begins here. If the patient wishes to use NRT, he or she is recommended to start on the quit day. On the quit day, a telephone call is made to the patient in an attempt to increase motivation. After 2 days of quitting, another interview is conducted if possible. In these interviews, nicotine withdrawal symptoms, strategies to overcome them, side effects or any other problems associated with drugs (if used), and reinforcement of motivation are discussed. Subsequently, similar interviews are conducted every 10 to 15 days.
Treatment Groups
There were 4 different treatment groups. The first group was treated with behavioral counseling (BC; motivational interviewing with lifestyle modification) only, the second group received BC with NRT, the third received BC with bupropion, and the fourth BC with varenicline. Smokers' choice of treatment group was discussed with them based on their smoking history, FNDT scores, and indications and contraindications set out by the Turkish Ministry of Health. NRT is mostly used with smokers with FNDT scores <3, and varenicline or bupropion with smokers with FNDT scores ≥3. All drugs were provided free for 3 months during the study period by the Ministry of Health. Written consent was obtained from all patients before initiating pharmacotherapy. NRT is used in doses of 21 mg, either as gum or patches, for as long as necessary. Bupropion is recommended at 150 mg for the first 3 days of therapy and 300 mg from the fourth day, usually for 3 months. Varenicline is used at 500 mg for the first 3 days, 1000 mg between the fourth and seventh days, and 2000 mg from the eighth day, usually for 3 months.
Anger Management and Stress Control Skills Training Program
The cognitive behavioral therapy—oriented anger management and stress control program was applied to the study group for 5 weeks in 90-minute sessions as soon as the standard cessation program was initiated (2 days after the first interview). We designed a 5-session program (90 minutes each). The program is structured along eclectic, educational, and didactic experimental principals in accordance with time limitations. Many resources were used to design the program, as mentioned elsewhere. The program content is presented in Appendix 1. Participants are expected to acquire the following skills: ability to notice clues to anger and stress; ability to recognize physical, emotional, and behavioral responses to sources of stress and anger; ability to learn and use techniques of relaxation and proper breathing for the control of stress in daily life; to gain awareness of anger and stress-related situations, such as uncontrolled behavior, physical assaults, or regrettable behavior; to gain awareness of the damaging effects of stress and anger on relationships, overeating, smoking, or drug use to appease anger and stress together with associated physical and legal problems; ability to recognize anger and stress-related negative automatic thoughts, and core and adjacent beliefs, and the ability to detect and define negative emotions that accompany these as they arise; ability to use various skills and cognitive restructuring to control stress and anger; ability to recognize cognitive diversions; ability to share emotions without aggression; ability to use effective communication, social interaction, time management, use of humor, changes in the environment, and so on; ability to express anger and other negative emotions with "I" language; ability to use effective listening skills and notice inappropriate listening reactions; ability to control stress and anger and to display willingness to maintain communication and create empathy in an attempt to establish understanding at times of conflict. As usual in cognitive behavioral—oriented therapy, 2 additional sessions were held at the third and sixth months aiming to overview the content of the anger management and stress control program and share participants' experiences. Before these sessions, the first and second follow-ups using the Trait Anger Scale (TAS) of the State and Trait Anger Scale and the Self-Confident subscale (SCS) and Hopeless subscale (HS) of the Stress Coping Styles Inventory were applied to the participants in the study group.
Tools
Fagerstrom Test for Nicotine Dependency. The FNDT is a 6-item self-report scale frequently used worldwide to determine levels of nicotine addiction. Although the test is actually modified from the Fagerstrom Tolerance Questionnaire, it has better internal consistency and is more easily answered. In terms of the overall logic of this test, it is based on number of cigarettes smoked and length of smoking-free periods. The instrument yields a dependency score between 0 (low) and 10 (high).
State Trait Anger Scale. Developed by Spielberger et al, the State Trait Anger Scale has 2 main subscales, the TAS, consisting of 10 self-reported items, and the Anger Expression Scale, which has 3 different subscales of 8 self-reported items (a total of 24 items). We used TAS scores as variables indicating trait anger level for this research. An individual can score between 0 and 40 on the TAS. Higher scores on the TAS indicate that the individual's trait anger level is high. Validity and reliability of the Turkish version of the test was investigated by Ozer. Cronbach α values have been calculated as 0.90 for the State Trait Anger Scale and between 0.82 and 0.90 for the subscales.