Clinical trial NCT05654545: Smoking Cessation Coaching in High-Risk Situations: A Virtual Reality Study
Official title: Examining the Effect of Personalized Advice of a Conversational Agent for Smoking Cessation in High Risk Situations: An Experimental Study Using Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Coaching
Chatbot
High-Risk situations
eHealth
Virtual Reality
Smoking
Relapse prevention
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A repeated measures within-subjects design will be employed. Conditions (the type of dialog) will be counterbalanced to minimize carryover effects. Baseline questionnaires measuring demographic characteristics, previous experience with VR, and smoking-specific characteristics will be administered at the start of the experiment. In addition, questionnaires measuring abstinence self-efficacy (i.e., the endpoint for the primary objective), phasic (state) tobacco craving, positive and negative affect, and sense of presence will be administered after every VR session (four times in total) to investigate the study objectives. Positive and negative affect will also be assessed before the VR sessions as a baseline measure. Finally, questionnaires measuring acceptance of the conversational agent and user-experiences will be administered after the last VR session.
Primary purpose: PREVENTION

Brief summary: Smoking tobacco is an important preventable risk factor for chronic illnesses and premature death and is most prevalent among groups with a lower socio-economic position (SEP). High relapse rates show that smoking cessation interventions are often not sufficiently effective on the long-term. Potential reasons for this limited effectiveness are that these interventions are not tailored to lower-SEP smokers and do not provide sufficient support in situations when the (re)lapse risk is high; that is, high-risk situations (HRSs). A mobile phone application using an automated conversational agent could be a useful approach to promote long-term smoking cessation, as it can be tailored to lower-SEP smokers and provide support at any time of the day (also in HRSs). However, evidence on the effectiveness of this kind of applications is scarce and it is still unclear how automated conversational agents can effectively promote lapse prevention. Therefore, it is important to explore what type of lapse prevention strategies these conversational agents should use in HRSs and how these different types of support are experienced by smokers.

This virtual reality (VR) experiment will examine the preliminary effectiveness and usability of a conversational agent that supports smokers in personal HRSs. More specifically, the investigators primarily aim to examine whether the three different lapse prevention dialogs increase abstinence self-efficacy in adult smokers from different SEP groups during simulated HRSs, compared to a neutral dialog (i.e., control condition). In addition, the investigators examine the effect of the lapse prevention dialogs, compared to the neutral dialog, in simulated HRSs on subjective craving and affect. Finally, the investigators examine how adult smokers from different SEP groups experience the personalized support of a simulated conversational agent in simulated HRSs.

VR will be used to expose smokers to their personal HRSs and let them interact with a conversational agent via a simulated mobile phone. Using computer-based VR technology, three-dimensional environments can be created based on environments that smokers encounter in their daily lives (e.g., their living room or the train station from where they travel to work). This way, controlled but at the same time natural-looking environments can be used to expose smokers to their personal HRSs and measure their responses in this situation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Being able to read and understand Dutch
* Smoking ≥ 10 cigarettes a day
* Intention to quit smoking sometime in the future
* Being able to wear a VR helmet for approximately 30 minutes, with breaks in between
* Willingness to take and send videos and audio of three locations where the participant is most likely to smoke (i.e., highest chance of smoking when in the environment)

Exclusion Criteria:

* Visual problems (e.g., limited visibility without glasses) that affect viewing VR environments (based on self-report)
* Currently involved in smoking cessation activity or therapy (based on self-report)
* When patients are deemed unfit to participate (due to, for example, psychological problems or medication). This decision is left to the discretion of the responsible researcher.

Primary outcomes:
measure: Abstinence self-efficacy
timeFrame: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
Secondary outcomes:
measure: Phasic (state) tobacco craving
timeFrame: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
measure: Positive and negative affect
timeFrame: At the start of the experiment (baseline) and four times during the experiment, which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4)
measure: Acceptance of the conversational agent
timeFrame: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
measure: User-experience / usability
timeFrame: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
Other outcomes:
measure: Sense of presence
timeFrame: Four times during the experiment, which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4)
measure: Demographic characteristics
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
measure: Previous experience with VR
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
measure: Intention to quit smoking
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
measure: Tonic (trait) tobacco craving
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
measure: Physical nicotine dependence.
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
measure: Latency since last cigarette smoked
timeFrame: At the start of the experiment (baseline); experiment has a duration of 1.5 hours
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center (LUMC)
name: Anke Versluis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center (LUMC)
name: Eline Meijer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: