Exploring the Experiences of Individuals Allocated to a Control Setting: Findings From a Mobile Health Smoking Cessation Trial.

backgroundTobacco smoking is the primary cause of preventable premature disease and death worldwide. Evidence of the efficacy of text messaging interventions to reduce smoking behavior is well established, but there is still a need for studies targeting young people, especially because young adult smokers are less likely to seek treatment than older adults. A mobile health intervention, Nicotine Exit (NEXit), targeting smoking among university students was developed to support university students to quit smoking. Short-term effectiveness was measured through a randomized controlled trial, which found that immediately after the 12-week intervention, 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group.

objectiveThe objective of this study was to explore the experience of being allocated to the control group in the NEXit smoking cessation intervention.

methodsWe asked students who were allocated to the control group in the main NEXit randomized controlled trial to report their experiences. An email was sent to the participants with an electronic link to a short questionnaire. We assessed the distribution of the responses to the questionnaire by descriptive analysis. We analyzed free-text comments to 4 questions.

resultsThe response rate for the questionnaire was 33.8% (258/763), and we collected 143 free-text comments. Of the responders, 60.9% (157/258) experienced frustration, disappointment, and irritation about being allocated to the control group; they felt they were being denied support by having to wait for the intervention. Monthly text messages during the waiting period thanking them for taking part in the trial were perceived as negative by 72.3% (189/258), but for some the messages served as a reminder about the decision to quit smoking. Of the responders, 61.2% (158/258) chose to wait to quit smoking until they had access to the intervention, and 29.8% (77/258) decided to try to quit smoking without support. Of the respondents, 77.5% (200/258) claimed they were still smoking and had signed up or were thinking about signing up for the smoking cessation program at the time of the questionnaire.

conclusionsMost of the respondents reported negative feelings about having to wait for the support of the intervention and that they had decided to continue smoking. A similar number decided to wait to quit smoking until they had access to the intervention, and these respondents reported a high interest in the intervention. Free-text comments indicated that some control group participants believed that they had been excluded from the trial, while others were confused when asked to sign up for the intervention again.

trial registrationISRCTN Registry ISRCTN75766527; http://www.isrctn.com/ISRCTN75766527 (Archived by WebCite at http://www.webcitation.org/7678sUKbR).