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A pilot randomised trial of a brief virtual reality scenario in smokers unmotivated to quit: Assessing the feasibility of recruitment [1]

['Olga Perski', 'Department Of Behavioural Science', 'Health', 'University College London', 'London', 'United Kingdom', 'Spectrum Consortium', 'Trupti Jambharunkar', 'Jamie Brown', 'Dimitra Kale']

Date: 2022-08 

The CONSORT checklist of pilot trials [ 22 ] was used to inform the study design and write-up (see S1 CONSORT Checklist ). This was a parallel-arm, pilot randomised trial conducted remotely with unmotivated, adult smokers randomised to the intervention and control arms in a 1:1 ratio using block randomisation (block size = 5). The random sequence was generated by the first author in R v.3.6.3 using the blockrand package [ 23 ]. According to the National Institute for Health Research, pilot studies are “a smaller version of the main study used to test whether the components of the main study can all work together” [ 24 ]. The study protocol and analysis plan were pre-registered on the Open Science Framework (osf.io/95tus). We aimed to recruit a total of 60 participants (30 in each arm). For pilot studies, sample sizes between 24 and 50 participants have been recommended [ 25 – 27 ]. We aimed to recruit an additional 10 participants to account for potential study dropout. This study was single blinded (i.e., participants were not aware of the group allocation).

Given the nature of the hospital-based VR scenario, which aimed to increase smokers’ perceived susceptibility to cancer (described in detail in section 2.5 below), we did not judge it ethical to include participants with a cancer diagnosis. Therefore, these participants were not eligible to take part, assessed by asking: “Have you been diagnosed with cancer?”. For a similar reason, participants with severe health anxiety were not eligible, determined by a score of ≥5 on the validated 14-item Whitely Index [ 29 , 30 ].

Due to a slower than expected recruitment rate, the inclusion criteria were amended in April 2021 (registered on the OSF prior to implementation; osf.io/5xzru/) to no longer restrict recruitment to participants with access to a VR headset. Instead, participants residing in the United Kingdom (UK) who were willing to be gifted an inexpensive headset (i.e., Google Cardboard worth ~£7) via post were also eligible to take part. The geographical limit was set to reduce postal costs, reduce delay between consenting and receipt of the headset, and minimise the testing burden caused by time differences between researchers and participants in different time zones.

Participants were eligible to take part if they: i) were aged 18+ years; ii) were a fluent English speaker; iii) were a daily or non-daily smoker; iii) were considered ‘unmotivated’ to stop smoking in the next three months (i.e., a Motivation To Stop Scale (MTSS) score of ≤5; [ 3 , 28 ]); iv) had access to a VR headset capable of running the YouTube app (without or with the help of a smartphone); v) were willing and able to meet with a researcher to complete the online testing via teleconferencing software (e.g., Microsoft Teams, Zoom); and vi) had corrected-to-normal vision.

Participants were recruited by adverts stating that the researchers were looking for smokers to provide feedback on a brief VR scenario, which mentioned a gift voucher to reimburse participants for their time. Adverts were placed on social media (i.e., Twitter, Facebook, Reddit), Prolific ( www.prolific.co ), e-mails sent through university mailing lists, and the researchers’ networks.

2.4 Measures and procedure

Interested participants were asked to complete screening questions relating to the above eligibility criteria via a brief online survey, hosted by Qualtrics. They were also asked to provide information about their i) country of residence, ii) gender (male, female, in another way), iii) occupational status (manual, non-manual, other), iv) whether they owned a VR headset (no, yes), v) type of VR headset (free text response), vi) experience with VR headsets (none, limited, some, substantial), vii) cigarettes smoked per day (CPD), viii) time to first cigarette (TTFC), ix) whether they had made any serious attempts to stop smoking in the past year, and x) whether they had ever used one or more behavioural and/or pharmacological stop smoking aids from a list of options (i.e., nicotine replacement therapy, varenicline, bupropion, e-cigarettes, group counselling, individual counselling, telephone helpline, written materials, website, app).

In the first recruitment phase (prior to the amendment to send headsets), eligible participants were randomised via Qualtrics’ block randomisation function to the intervention or control arms. They were subsequently invited via e-mail to complete the online testing with a researcher present via videoconferencing software. When booking the meeting, participants received instructions to have their smartphone and/or VR headset charged and ready for the online testing. Instructions were identical for intervention and control participants. Reminders to book a meeting were sent to control and intervention participants with equal frequency (i.e., two reminders).

In the second recruitment phase (following the amendment to send headsets), participants who indicated that they did not have access to a VR headset were asked to meet with the researcher twice: first to provide their personal details (i.e., name, postal address, contact number) to enable the researcher to order a VR headset via Amazon to be delivered to the participant, and second to complete the online testing. After having booked a meeting to complete the online testing (irrespective of whether participants were sent a headset), participants were randomised to the intervention or control arms.

During the online testing, participants allocated to the intervention arm were asked to search for and view the active VR scenario within the YouTube app. Participants allocated to the control arm were asked to search for and view the ‘sham’ scenario. Immediately after viewing the VR scenario, participants were asked to complete a post-test survey, hosted by Qualtrics.

First, acceptability was examined by assessing participants’ affective and cognitive attitudes towards the respective scenarios [21]. As both the intervention and control scenarios were delivered in VR, we aimed to assess the acceptability of the specific content delivered in VR format (i.e., there were no 2D controls to examine the comparative acceptability of VR per se). Although there is no consensus definition of acceptability, we recently proposed that acceptability may usefully be considered an emergent property of a complex, adaptive system of multiple, interacting components (e.g., beliefs, knowledge), which is experienced by the individual as a gut reaction or sudden insight [20]. Until further questionnaire development and validation work has been conducted, we reasoned that this sudden insight may be usefully operationalised as affective and cognitive attitudes. Affective attitude was measured by asking participants to rate their agreement with the following statements on a 7-point Likert scale (i.e., ‘strongly disagree’ to ‘strongly agree’): “The scenario made me feel angry”; “The scenario made me feel distressed”. Cognitive attitude was measured by asking participants to rate their agreement with the following statement on a 7-point Likert scale (i.e., ‘strongly disagree’ to ‘strongly agree’): “The scenario was useful to me”. Responses were coded as ‘acceptable’ if participants selected ‘disagree’ or ‘strongly disagree’ for the affective attitude, and ‘agree’ or ‘strongly agree’ for the cognitive attitude, and ‘unacceptable’ otherwise. These items were developed for the purposes of the present study and have not been validated.

Second, participants were asked to provide a rating of their perceived susceptibility to smoking-related diseases, perceived response-efficacy and perceived quitting self-efficacy. Perceived susceptibility was measured with three items: “What do you think your likelihood is of developing (or if you have, the worsening of) the following diseases if you continue smoking?” i) cancer, ii) heart disease, and iii) lung disease. Each were assessed on a 5-point Likert scale (i.e., ‘not at all’ to ‘very likely’) [31]. Responses were coded as ‘susceptible’ (‘moderately likely’ or ‘very likely’) or ‘not susceptible’ (all other response options). Perceived response-efficacy was measured on a 5-point Likert scale (‘strongly disagree’ to ‘strongly agree’) with the following items: “Quitting smoking is an effective protector against cancer”; “Quitting smoking is an effective protector against heart disease”; and “Quitting smoking is an effective protector against lung disease.” Due to a coding error when setting up the Qualtrics survey, 7-point (rather than 5-point) Likert scales were used (‘strongly disagree’ to ‘strongly agree’). Responses were coded as ‘confident’ (‘agree’ or ‘strongly agree’) or ‘not confident’ (all other response options). Perceived quitting self-efficacy was measured on a 5-point Likert scale (i.e., ‘not at all’ to ‘extremely’) with the following item: “How confident are you in your ability to abstain from smoking?” [32]. Responses were coded as ‘confident’ (‘very’ or ‘extremely’) or ‘not confident’ (all other response options).

Participants were then presented with a link to a website with additional, evidence-based information about smoking cessation (http://www.nhs.uk/smokefree). A record was made if a participant clicked on the link provided–the act of clicking was interpreted as a behavioural indicator of intention to stop smoking.

As compensation for their time, participants with their own headset received a £5 gift voucher (or equivalent payment via Prolific) upon completion of the study. Participants without a headset were gifted a cardboard headset (~£7).

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[1] Url: https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000060

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