Waterpipe Cessation Intervention Study
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      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: 
      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.
    

Intervention name(s): Waterpipe smoking cessation
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation, Waterpipe