Dickson‐Spillmann 2013.
Methods | Setting: Swiss Institute for Research in Public Health and Addictions, which is associated with the University of Zurich, Switzerland. Study period: April 2011 to February 2012. Recruitment: through advertisements in online and print newspapers. Sample size calculation: described for initial planned simple RCT and then redone as authors realized the study is a cluster‐RCT. |
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Participants | Number of participants: 223 smokers (hypnosis: 116; relaxation: 107). Inclusion criteria: current smokers prepared to stop smoking; smoking ≥ 5 cigarettes per day; aged 18 to 65 years; not using other cessation aids; understand and speak German; no history of psychotic disorders; not be intoxicated before or during the intervention. Exclusion criteria: using other cessation aids; history of psychotic disorders; intoxicated before or during the intervention. Overall demographics: women (47%); mean age = 37.5 (SD 11.8); Swiss (86.1%) years; mean FTND = 4.7. | |
Interventions | a) Hypnosis b) Relaxation Both groups received a 40‐minute psychoeducation session before their intervention, a 20‐minute debriefing after the intervention, and a CD for use at home. Both interventions comprised a single 40‐minute session of group treatment. Participants were required to pay CHF 40 to participate in the study. |
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Outcomes | Definition of smoking cessation: biochemically validated (saliva cotinine < 5 ng/mL undertaken by post) 30‐day point prevalence of smoking abstinence at a 6‐month follow up. Adverse events: collected at 2‐week telephone follow‐up interview and at 6‐month postal follow‐up questionnaire. | |
Notes | Funding: Swiss Tobacco Prevention Fund. Author declaration of interest: "The authors declare that they have no competing interests". The study was initially planned as an individually‐randomized RCT but analysis was changed to that suitable for a cluster‐RCT when it was realized that the unit of recruitment was clusters (e.g. groups of work colleagues). Cluster randomization was accounted for in the analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence of 20 sessions generated using an online programme with ratio of 1:1 for number of sessions per intervention; one additional last session was randomly allocated by the same programme. Does not state if a block size was used or not |
Allocation concealment (selection bias) | Low risk | Therapist blinded until delivery of intervention; therapist was informed by text immediately prior as to which intervention should be delivered. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated so differential misreport judged unlikely |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Those with absent saliva sample (n = 1), and those with saliva cotinine higher than usual for occasional smokers (n = 3), were classed as smokers. At 6 months, LTFU for the hypnosis and relaxation groups was 14.7% and 17.1%, respectively. |
Selective reporting (reporting bias) | Unclear risk | Primary outcome variable reported and information provided on numbers without biochemical validation. However, 2‐week, but not 6‐month, AE data reported and reason for this omission is unclear. |