Waterpipe Cessation Intervention Study

Study Overview
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Brief Summary
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The study is a two-group parallel arm randomized clinical trial, to be conducted at the Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria.

Detailed Description
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The study is a two-group parallel arm randomized clinical trial, to be conducted at the Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria. Subjects will be recruited by flyers, ads, and word of mouth. Smokers who are interested in receiving free stop-smoking assistance as part of a research study will be asked to contact the study office at the SCTS. Eligibility will be determined by a brief phone screen to determine age, number of years as a smoker and current amount smoked per week, and medical history. Individuals who meet these requirements will be invited to an orientation/screening session at the SCTS to learn more about the study. At the orientation/screening session, the study will be described to interested individuals, their questions will be answered, and those interested in participating will be asked to sign the informed consent document. Participants then will provide baseline demographic information (age, gender, ethnicity, residence, marital status, education, occupation, income) and smoking related information (smoking history, level of dependence, interest in quitting, medical history), and answer other study questionnaires (e.g., self-efficacy, stages of change, and withdrawal symptoms, depression or mood scale). Body weight will be assessed with a calibrated balance-beam scale. Participants will then be randomized to one of two intervention groups. Subjects in arm A will receive a brief (approximately 15 minute) motivational and educational intervention, delivered by a trained physician from the SCTS, plus written self-help materials. The self-help materials will be adapted and translated into Arabic from existing validated materials from the American Cancer Society and the University of Memphis School of Public Health. Subjects in Arm B will receive behavioral counseling intervention conducted by a trained physician at the SCTS cessation clinic. Both self-help materials and behavioral intervention will be adapted from established clinical practice guidelines for cigarette smokers (Fiore et al., 2008), experience gained at SCTS with cigarette smokers, and information about the waterpipe gained from previous epidemiological, ethnographic, and clinical studies conducted by the SCTS. Subjects will be requested to do homework before the session to facilitate this process. Subjects will be asked to identify high-risk situations and difficulties in previous cessation attempts and will be walked through a series of suggestions in the event of a slip. We also will provide 3 brief (approximately 10 minute) phone calls to subjects during the 90 day follow-up period. These calls are used to identify early relapse, encourage participants, and provide support. In addition, they are used to review materials and information provided during the sessions. All subjects (Arms A and B) will undergo follow-up assessment at 3 months post-cessation. Data collected at the 3-month follow-up will include expired air carbon monoxide level and several self-report measures, including smoking status, stage of change, and depressive symptomatology. In addition, subjects will be administered a semi-structured questionnaire to assess the perceived usefulness and appropriateness of several features of the cessation intervention (e.g., helpfulness of the interventionist and self-help materials, convenience of the timing and location of the sessions, and usefulness of the phone calls), along with suggestions for improving the intervention. All subjects will receive reminder phone call before the follow-up visits. All intervention providers will undergo six hours of training for smoking cessation intervention counseling. This training will include general training on intervention delivery, based on current clinical practice standards in developed countries and specific training on study protocols using standardized intervention training materials developed at the University of Memphis.

Official Title
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Pilot Test of a Cessation Intervention for Waterpipe Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Waterpipe smoking cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-60 years) regular water pipe smokers in Aleppo(at least twice per week for past year) interested in quitting access to a telephone Exclusion Criteria: unstable cardiovascular, psychiatric, or other debilitating diseases inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Motivational and educational intervention, delivered by a trained physician from the SCTS plus written self-help materials. | Behavioral: Waterpipe smoking cessation<br>* The main objective of this study is to compare two levels of intensity of a behavioral intervention for waterpipe smoking cessation, using a randomized controlled trial design. In this trial, brief motivational intervention with self-help materials will be compared with intensive behavioral counseling with four sessions, in order to test the efficacy of each of these interventions. This pilot testing will help us; 1) test the potential efficacy of the developed intervention, 2) fine-tune the intervention in terms of content and format, and 3) assess issues related to recruitment and retention. Thus, feedback from participants and intervention staff will form an essential part of this pilot study to assess the adopted approaches and suggest appropriate modifications.<br>|
| Experimental: Arm B<br>Behavioral counseling intervention conducted by a trained physician at the SCTS cessation clinic. Subjects complete homework before the session to facilitate this process. Subjects are asked to identify high-risk situations and difficulties in previous cessation attempts and are walked through a series of suggestions in the event of a slip. Three brief (approximately 10 minute) phone calls are provided to subjects during the 90 day follow-up period. These calls are used to identify early relapse, encourage participants, and provide support. In addition, they are used to review materials and information provided during the sessions. | Behavioral: Waterpipe smoking cessation<br>* The main objective of this study is to compare two levels of intensity of a behavioral intervention for waterpipe smoking cessation, using a randomized controlled trial design. In this trial, brief motivational intervention with self-help materials will be compared with intensive behavioral counseling with four sessions, in order to test the efficacy of each of these interventions. This pilot testing will help us; 1) test the potential efficacy of the developed intervention, 2) fine-tune the intervention in terms of content and format, and 3) assess issues related to recruitment and retention. Thus, feedback from participants and intervention staff will form an essential part of this pilot study to assess the adopted approaches and suggest appropriate modifications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | The endpoint of cessation will be defined as no self-reported tobacco use, confirmed by expired carbon monoxide of less than 10ppm, at the 3 month post-cessation follow-up visit. Three indicators of cessation will be assessed, including prolonged abstinence (no smoking after two weeks post-quit date), continuous abstinence (no smoking after the quit date), and point-prevalent abstinence (no smoking for the past 7 days). | 3 months post-cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of change | Stage of change in the cessation process (pre-contemplation, contemplation, preparation, action, relapse) based on Prochaska & DiClemente's transtheoretical model. | 3 months post-cessation | 
| Depressive symptomatology | Self-reported symptoms of depression, based on the CES-D | 3 months post-cessation | 
| Intervention acceptability | Self-report process measures will be used to assess subject perceptions of helpfulness of the interventionist and self-help materials, convenience of the timing and location of intervention sessions, and usefulness of brief phone intervention contacts. | 3 months post-cessation | 
| Fagerström Test for Nicotine Dependence (FTND) | To assess smokers'degree of nicotine dependence. Based on Heatherton TF et al. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86:1119-1127. | 3 months post-cessation | 
| Social Support | To assess smokers'perceived social support. Based on Procidano ME & Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983;11:1-24. | 3 months post-cessation | 
| Smoking-specific self-efficacy | To assess smokers' confidence in his/her ability to keep from smoking in a range of different situations. Based on Velicer WF et al. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15:271-283. | 3 months post-cessation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Waterpipe